{"title":"Nurofen","description":"\u003cp\u003eFarmaci della linea Nurofen a base di ibuprofene, per abbassare la febbre e calmare il dolore. Disponibili in compresse rivestite, capsule molli a rapido assorbimento, bustine da sciogliere, compresse orosolubili e sospensione orale al gusto fragola per i bambini. Utili per mal di testa, mal di denti, dolori mestruali, influenza e raffreddore. Spedizione veloce in 24\/48 ore.\u003c\/p\u003e","products":[{"product_id":"nurofen-febbre-e-dolore-200mg-5ml-sospensione-orale-gusto-fragola-senza-zucchero-100ml","title":"Nurofen Fever and Pain 200mg\/5ml oral suspension strawberry flavour sugar free 100ml","description":"\u003cp\u003e\u003cstrong\u003eINDICATIONS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eSymptomatic treatment of fever and mild or moderate pain.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eACTIVE INGREDIENTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eNUROFEN FEVER AND PAIN 200 mg\/5ml Oral Suspension Each ml of oral suspension contains active ingredient: ibuprofen 40 mg. Excipients with known effects: liquid maltitol, propylene glycol (present in the strawberry flavour), wheat starch (present in the orange flavour) and sodium. For the full list of excipients, see section 6.1.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eEXCIPIENTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cu\u003eNurofen Fever and Pain 200mg\/5ml oral suspension orange flavor without sugar \u003c\/u\u003e Polysorbate 80, glycerin, maltitol syrup, sodium saccharin, citric acid, sodium citrate, xanthan gum, sodium chloride, orange flavor, domiphene bromide, purified water. \u003cu\u003eNurofen Fever and Pain 200mg\/5ml oral suspension strawberry flavor without sugar \u003c\/u\u003e Polysorbate 80, glycerin, maltitol syrup, sodium saccharin, citric acid, sodium citrate, xanthan gum, sodium chloride, strawberry flavor, domiphene bromide, purified water.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eCONTRAINDICATIONS AND SIDE EFFECTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e• Hypersensitivity to ibuprofen or to any of the excipients listed in section 6.1. • Children under 2 years of age or weighing less than 10 kg. • The medicinal specialty is contraindicated in patients who show or have previously shown hypersensitivity (e.g. asthma, rhinitis, angioedema or urticaria) to acetylsalicylic acid or other analgesics, antipyretics, non-steroidal anti-inflammatory drugs (NSAIDs), in particular when hypersensitivity is associated with nasal polyposis and asthma. • Active peptic ulcer. • Severe renal or hepatic impairment (see section 4.4). • Severe heart failure (see section 4.4). • History of gastrointestinal bleeding or perforation related to previous NSAID-based therapy. • History of recurrent peptic hemorrhage\/ulcer (two or more distinct episodes of demonstrated ulceration or bleeding). • Concomitant use of NSAIDs, including specific COX-2 inhibitors. • During the last trimester of pregnancy (see section 4.6).\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eDOSAGE\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cu\u003eDosage \u003c\/u\u003e Undesirable effects can be minimized by using the lowest effective dose for the shortest possible treatment duration needed to control symptoms (see section 4.4). \u003cb\u003e \u003cu\u003eAdults and adolescents over 12 years old\u003c\/u\u003e (\u003c\/b\u003e \u003cu\u003e≥ 43 kg body weight)\u003c\/u\u003e: 200-400 mg of ibuprofen (corresponding to 5 - 10 ml of oral suspension), 2-3 times a day. The interval between doses should not be less than 4 hours. Do not exceed the maximum dose of 1200 mg (30 ml) in 24 hours. Use in adults is especially indicated in patients with dysphagia. \u003cb\u003e \u003cu\u003eElderly\u003c\/u\u003e:\u003c\/b\u003e No changes to the dosage schedule are required. \u003cb\u003e \u003cu\u003ePediatric population\u003c\/u\u003e \u003c\/b\u003e \u003cb\u003e \u003cu\u003eChildren between 2 - 12 years (10 - 43 kg body weight)\u003c\/u\u003e \u003c\/b\u003e The daily dose is structured based on the weight and age of the patient. The daily dose of 20-30 mg\/kg of body weight, divided 3 times a day at 6-8 hour intervals, can be administered based on the following schedule (do not exceed the recommended doses).\u003c\/p\u003e\n\u003cp\u003eWeight: From 10 Kg - Approximate age: 2 - 3 years. Single dose in ml: 2.5 ml. maximum number of administrations\/day: 3 in 24 hours.\u003c\/p\u003e\n\u003cp\u003eWeight: From 15 Kg - Approximate age: 4 - 6 years. Single dose in ml: 3.75 ml. maximum number of administrations\/day: 3 in 24 hours.\u003c\/p\u003e\n\u003cp\u003eWeight: From 20 kg - Approximate age: 7 - 9 years. Single dose in ml: 5 ml. maximum number of administrations\/day: 3 in 24 hours.\u003c\/p\u003e\n\u003cp\u003eWeight: From 28 to 43 Kg - Approximate age: 10 - 12 years. Single dose in ml: 7.5 ml. maximum number of administrations\/day: 3 in 24 hours.\u003c\/p\u003e\n\u003cp\u003eSpecial populations: in the case of post-vaccination fever, refer to the dosage indicated above, the administration of a single dose (2.5 ml) followed, if necessary, by another dose after 6 hours is recommended. Do not administer more than two doses in 24 hours. Consult your doctor if fever does not decrease. The product is intended for short-term treatments. If the use of the medicine is necessary for more than 3 days in children over 2 years of age, in adolescents and adults, or in the case of worsening of symptoms, a doctor should be consulted. \u003cu\u003eMethod of administration \u003c\/u\u003e Oral administration should take place using the measuring syringe or measuring spoon supplied with the product. The graduated scale on the body of the syringe highlights the marks for the different dosages: in particular the 2.5 ml mark corresponding to 100 mg of ibuprofen, the 3.75 ml mark corresponding to 150 mg of ibuprofen and the 5 ml mark corresponding to 200 mg of ibuprofen. The measuring spoon has two concave blades at the ends for the different doses: the 1.25 ml mark corresponding to 50 mg of ibuprofen, the 2.5 ml mark corresponding to 100 mg of ibuprofen and the 5 ml mark corresponding to 200 mg of ibuprofen. Patients suffering from stomach problems can take the medicine with meals. \u003cu\u003eInstructions for using the dosing syringe\u003c\/u\u003e: 1 - Unscrew the cap by pushing it downwards and turning it to the left. 2 - Insert the tip of the syringe fully into the hole in the undercap. 3 - Shake well. 4 - Turn the bottle upside down, then, holding the syringe firmly, gently pull the plunger downwards, allowing the suspension to flow into the syringe up to the mark corresponding to the desired dose. 5 - Put the bottle back in a vertical position and remove the syringe by rotating it gently. 6 - Introduce the tip of the syringe into your mouth and apply slight pressure on the plunger to let the suspension flow out. 7- After use, screw the cap to close the bottle and wash the syringe with hot water. Leave it to dry, keeping it out of the sight and reach of children.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eCONSERVATION\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eDo not store above 30°C.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eWARNINGS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eSide effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see paragraphs below on gastrointestinal and cardiovascular risks). The use of Nurofen Fever and Pain must be avoided in conjunction with NSAIDs, including selective COX-2 inhibitors. Analgesics, antipyretics, non-steroidal anti-inflammatory drugs can cause potentially serious hypersensitivity reactions (anaphylactoid reactions), even in subjects not previously exposed to this type of drugs. The risk of hypersensitivity reactions after taking ibuprofen is greater in subjects who have experienced such reactions after the use of other analgesics, antipyretics, non-steroidal anti-inflammatory drugs and in subjects with bronchial hyperreactivity (asthma), nasal polyposis or previous episodes of angioedema (see section 4.2 and section 4.8). Gastrointestinal haemorrhage, ulceration and perforation: Gastrointestinal haemorrhage, ulceration and perforation, which may be fatal, have been reported at any time during treatment with all NSAIDs, with or without warning symptoms or previous history of serious gastrointestinal events. In dehydrated children and adolescents there is a risk of impaired renal function (see sections 4.3 and 4.8). Elderly: Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which may be fatal (see section 4.2). In the elderly and in patients with a history of ulcer, especially if complicated by haemorrhage or perforation (see section 4.3), the risk of gastrointestinal haemorrhage, ulceration or perforation is higher with increased doses of NSAIDs. These patients should start treatment with the lowest available dose. The concomitant use of protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients and also for patients taking low doses of aspirin or other drugs that may increase the risk of gastrointestinal events (see section 4.5). Patients with a history of gastrointestinal toxicity, particularly the elderly, should report any unusual gastrointestinal symptoms (especially gastrointestinal haemorrhage) particularly in the initial stages of treatment. Caution should be exercised in patients taking concomitant medications that may increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or antiplatelet agents such as acetylsalicylic acid (aspirin) (see section 4.5). When gastrointestinal bleeding or ulceration occurs in patients taking Nurofen Fever and Pain, treatment should be discontinued. NSAIDs should be administered with caution to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated (see section 4.8). Severe skin reactions: Severe skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported rarely in association with the use of NSAIDs (see section 4.8). Patients appear to be at higher risk in the early stages of therapy: the onset of the reaction occurs in most cases within the first month of treatment. Acute generalized exanthematous pustulosis (PEAG) has been reported in connection with ibuprofen-containing medicinal products. Ibuprofen should be discontinued at the first appearance of signs and symptoms of severe skin reactions, such as rash, mucosal lesions or any other sign of hypersensitivity. Masking symptoms of underlying infections: Nurofen Fever and Pain may mask symptoms of infection, which could delay the start of adequate treatment and therefore worsen the outcome of the infection. This has been observed in community-acquired bacterial pneumonia and bacterial complications of chickenpox. When Nurofen Fever and Pain is administered for the relief of infection-related fever or pain, monitoring of the infection is advised. In non-hospital settings, the patient should seek medical attention if symptoms persist or worsen. Chickenpox can exceptionally cause serious infectious complications to the skin and soft tissues. To date, the contribution of NSAIDs in the worsening of these infections cannot be excluded, therefore it is advisable to avoid the use of Nurofen Fever and Pain in case of chickenpox. Caution is required (discuss with your doctor or pharmacist) before starting treatment in patients with a positive history of hypertension and\/or heart failure since fluid retention, hypertension and edema have been found in association with treatment with NSAIDs. Clinical studies and epidemiological data suggest that the use of ibuprofen, especially at high doses (2400 mg\/day) and for long-term treatments, may be associated with a modest increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke). In general, epidemiological studies do not suggest that low doses of ibuprofen (e.g. ≤ 1200 mg\/day) are associated with an increased risk of myocardial infarction. Patients with uncontrolled hypertension, congestive heart failure, established ischemic heart disease, peripheral arterial disease, and\/or cerebrovascular disease should be treated with ibuprofen only after careful consideration. Similar considerations must be made before starting long-term treatment in patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidemia, diabetes mellitus, smoking). The use of ibuprofen, acetylsalicylic acid or other analgesics, antipyretics, non-steroidal anti-inflammatories requires particular caution: • in case of current or previous asthma or allergic diseases: possible deterioration of bronchoconstriction; • in the presence of coagulation defects: reduction of coagulability; • in the presence of kidney disease, heart disease or hypertension: possible critical reduction in renal function (especially in subjects with impaired renal or hepatic function, heart failure or being treated with diuretics), nephrotoxicity or fluid retention; • in the presence of liver disease: possible hepatotoxicity; • rehydrate the subject before starting and during treatment in case of dehydration (for example due to fever, vomiting or diarrhea). The following precautions become relevant during prolonged treatments: • monitor for signs or symptoms of gastrointestinal ulceration or bleeding; • monitor for signs or symptoms of hepatotoxicity; • monitor for signs or symptoms of nephrotoxicity; • if visual disturbances occur (blurred or reduced vision, scotomas, alteration of color perception): stop treatment and consult your ophthalmologist; • if signs or symptoms of meningitis arise: evaluate the rare possibility that it is due to the use of ibuprofen (aseptic meningitis; more frequent in subjects suffering from systemic lupus erythematosus and mixed connective tissue disease or other collagenopathies) (see section 4.8). Since Nurofen Fever and Pain contains \u003cb\u003eliquid maltitol\u003c\/b\u003e, patients with rare hereditary problems of fructose intolerance should not take this medicine. May have a mild laxative effect. The caloric value of maltitol is 2.3 kcal\/g. Nurofen Fever and Pain does not contain sugar and is therefore indicated for those patients who need to control their intake of sugars and calories. This medicinal product contains less than 1 mmol (23 mg) of \u003cb\u003esodium\u003c\/b\u003e for doses up to 12 ml, i.e. essentially \"sodium-free\". This medicine contains approximately 27.6 mg of \u003cb\u003esodium\u003c\/b\u003e for each 15 ml dose, equivalent to approximately 1.4% of the maximum daily intake recommended by the WHO which corresponds to 2 g of sodium for an adult. NUROFEN FEVER AND PAIN 200 mg\/5ml oral suspension strawberry flavor without sugar contains approximately 16.45 mg of \u003cb\u003epropylene glycol\u003c\/b\u003e (present in the strawberry flavour) for 5 ml. NUROFEN FEVER AND PAIN 200 mg\/5ml sugar-free orange flavor oral suspension contains only a very small quantity of gluten (from\u003cb\u003ewheat starch\u003c\/b\u003e present in the orange flavour). This medicine is considered \"gluten-free\" and is very unlikely to cause problems for a celiac patient. A 5 ml dose contains no more than 0.315 micrograms of gluten. If the patient is allergic to wheat (condition other than celiac disease) he should not take this medicine.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eINTERACTIONS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cb\u003eIbuprofen should be avoided in association with\u003c\/b\u003e: • Acetylsalicylic acid (aspirin): unless low-dose acetylsalicylic acid (no more than 75 mg per day), as per common clinical practice, has been advised by your doctor, as it may increase the risk of adverse reactions (see section 4.4). Experimental data indicate that ibuprofen can inhibit the effects of low-dose acetylsalicylic acid on platelet aggregation when the drugs are administered concomitantly. However, the paucity of data and the uncertainties relating to the application of data extrapolated ex vivo to the clinical situation do not allow definitive conclusions to be drawn on the regular use of ibuprofen; Clinically relevant effects resulting from occasional use of ibuprofen are unlikely (see section 5.1). • \u003cb\u003eOther NSAIDs including selective cyclooxygenase-2 inhibitors\u003c\/b\u003e: avoid the simultaneous use of two or more analgesics, antipyretics, non-steroidal anti-inflammatory drugs: increased risk of side effects (see section 4.4). \u003cb\u003eIbuprofen should be used with caution in combination with:\u003c\/b\u003e • corticosteroids: increased risk of gastrointestinal ulceration or haemorrhage (see section 4.4); • quinolone antibiotics: data from animal studies indicate that NSAIDs may increase the risk of seizures associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may have an increased risk of developing seizures; • anticoagulants, such as warfarin: NSAIDs can increase the effects of anticoagulants (see section 4.4); • antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding (see section 4.4); • antidiabetics: possible increase in the effect of sulfonylureas; • antivirals, such as ritonavir: possible increase in the concentration of NSAIDs; • ciclosporin: increased risk of nephrotoxicity; • mifepristone: NSAIDs must not be administered in the 8-12 days following taking mifepristone as they can reduce its effectiveness; • cytotoxics, such as methotrexate: reduction of excretion (increased risk of toxicity); • lithium: reduction of excretion (increased risk of toxicity); • tacrolimus: increased risk of nephrotoxicity; • uricosurics, such as probenecid: slows down the excretion of NSAIDs (increase in plasma concentrations); • methotrexate: potential increase in plasma concentrations of methotrexate; • zidovudine: increased risk of blood toxicity when NSAIDs are used in combination with zidovudine. There are demonstrations of increased risk of haemarthrosis and hematomas in HIV (+) haemophiliacs if treated simultaneously with zidovudine and ibuprofen; • diuretics, ACE inhibitors and angiotensin II antagonists: NSAIDs can reduce the effect of diuretics and other antihypertensive drugs. In some patients with compromised renal function (e.g. dehydrated patients or elderly patients with compromised renal function) co-administration of an ACE inhibitor or an angiotensin II antagonist and agents that inhibit the cyclo-oxygenase system may lead to further deterioration of renal function, including possible acute renal failure, which is usually reversible. These interactions should be considered in patients taking Nurofen Fever and Pain concomitantly with ACE inhibitors or angiotensin II antagonists. Therefore, the combination should be administered with caution, especially in elderly patients. Patients should be adequately hydrated and monitoring of renal function should be considered after initiation of concomitant therapy and periodically; • Cardiac glycosides: NSAIDs can worsen heart failure, reduce GFR (glomerular filtration rate) and increase plasma levels of glycosides.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eSIDE EFFECTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eThe list of the following side effects includes all those that have been recognized during treatment with ibuprofen for short periods of treatment and for daily doses up to a maximum of 1200 mg. In the case of high-dose therapies for chronic or prolonged pathologies, other undesirable effects may occur. Adverse reactions associated with the administration of ibuprofen are listed below according to system organ class and frequency. Frequencies are defined as\u003ci\u003e:\u003c\/i\u003e Very common (≥1\/10); Common (≥1\/100, \u003c1\/10); Uncommon (≥1\/1,000, \u003c1\/100); Rare (≥1\/10,000, \u003c1\/1,000); Very rare (\u003c1\/10,000); Not known (frequency cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.\u003c\/p\u003e\n\u003cp\u003eInfections and infestations - Frequency: Rare. Adverse reaction: Cystitis, rhinitis.\u003c\/p\u003e\n\u003cp\u003eInfections and infestations - Frequency: Very rare. Adverse reaction: Worsening of infection-related inflammation (e.g. development of necrotizing fasciitis), in exceptional cases severe skin infections and soft tissue complications have been reported during a chickenpox infection.\u003c\/p\u003e\n\u003cp\u003eBlood and lymphatic system disorders - Frequency: Very rare. Adverse reaction: Hematopoiesis disorders ¹\u003c\/p\u003e\n\u003cp\u003eImmune system disorders - Frequency: Uncommon. Adverse reaction: Hypersensitivity reactions manifested by urticaria and pruritus²\u003c\/p\u003e\n\u003cp\u003eImmune system disorders - Frequency: Very rare. Adverse reaction: Severe hypersensitivity reactions including swelling of the face, tongue and larynx, dyspnoea, tachycardia, hypotension (anaphylaxis, angioedema or severe shock).\u003c\/p\u003e\n\u003cp\u003eMetabolism and nutrition disorders - Frequency: Not known. Adverse reaction: Fluid retention and decreased appetite³.\u003c\/p\u003e\n\u003cp\u003ePsychiatric disorders - Frequency: Not known. Adverse reaction: Irritability\u003c\/p\u003e\n\u003cp\u003ePsychiatric disorders - Frequency: Rare. Adverse reaction: Depression, insomnia, difficulty concentrating, emotional lability, visual and auditory disturbances.\u003c\/p\u003e\n\u003cp\u003eNervous system disorders - Frequency: Uncommon. Adverse reaction: Headache, dizziness, drowsiness, convulsions.\u003c\/p\u003e\n\u003cp\u003eNervous system disorders - Frequency: Very rare. Adverse reaction: Aseptic meningitis4.\u003c\/p\u003e\n\u003cp\u003eNervous system disorders - Frequency: Rare. Adverse reaction: Cerebrovascular haemorrhage.\u003c\/p\u003e\n\u003cp\u003eEye disorders - Frequency: Rare. Adverse reaction: Dry eyes.\u003c\/p\u003e\n\u003cp\u003eEar and labyrinth disorders - Frequency: Not known. Adverse reaction: Tinnitus.\u003c\/p\u003e\n\u003cp\u003eCardiac disorders - Frequency: Not known. Adverse reaction: Heart failure and edema5.\u003c\/p\u003e\n\u003cp\u003eCardiac disorders - Frequency: Rare. Adverse reaction: Palpitations.\u003c\/p\u003e\n\u003cp\u003eVascular disorders - Frequency: Not known. Adverse reaction: Hypertension5 and shock.\u003c\/p\u003e\n\u003cp\u003eRespiratory, thoracic and mediastinal disorders - Frequency: Not known. Adverse reaction: Respiratory tract reactivity including asthma, laryngeal obstruction, bronchospasm or apnea, dyspnea.\u003c\/p\u003e\n\u003cp\u003eGastrointestinal disorders - Frequency: Uncommon. Adverse reaction: Abdominal pain, nausea and dyspepsia6.\u003c\/p\u003e\n\u003cp\u003eGastrointestinal disorders - Frequency: Rare. Adverse reaction: Diarrhoea, flatulence, dry mouth, constipation and vomiting.\u003c\/p\u003e\n\u003cp\u003eGastrointestinal disorders - Frequency: Very rare. Adverse reaction: Peptic ulcer, gastrointestinal perforation or bleeding, melena and haematemesis7. Mouth ulcerations and gastritis.\u003c\/p\u003e\n\u003cp\u003eGastrointestinal disorders - Frequency: Not known. Adverse reaction: Exacerbation of colitis and Crohn's disease8, pancreatitis, duodenitis, esophagitis.\u003c\/p\u003e\n\u003cp\u003eHepatobiliary disorders - Frequency: Very rare. Adverse reaction: Liver dysfunction, hepatitis, jaundice, hepatorenal syndrome, hepatic necrosis, hepatic failure.\u003c\/p\u003e\n\u003cp\u003eSkin and subcutaneous tissue disorders - Frequency: Uncommon. Adverse reaction: Various skin rashes²\u003c\/p\u003e\n\u003cp\u003eSkin and subcutaneous tissue disorders - Frequency: Very rare. Adverse reaction: Bullous reactions including Stevens-Johnson syndrome, erythema multiforme and toxic epidermal necrolysis².\u003c\/p\u003e\n\u003cp\u003eSkin and subcutaneous tissue disorders - Frequency: Rare. Adverse reaction: Exfoliative dermatitis, alopecia, photosensitivity reactions.\u003c\/p\u003e\n\u003cp\u003eSkin and subcutaneous tissue disorders - Frequency: Not known. Adverse reaction: Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), acute generalized exanthematous pustulosis (PEAG).\u003c\/p\u003e\n\u003cp\u003eRenal and urinary disorders - Frequency: Rare. Adverse reaction: Tubular necrosis, glomerular nephritis, polyuria, hematuria.\u003c\/p\u003e\n\u003cp\u003eRenal and urinary disorders - Frequency: Very rare. Adverse reaction: Acute renal failure9.\u003c\/p\u003e\n\u003cp\u003eDiagnostic tests - Frequency: Rare. Adverse reaction: Decreased hematocrit levels.\u003c\/p\u003e\n\u003cp\u003eDiagnostic tests - Frequency: Very rare. Adverse reaction: Decreased hemoglobin levels.\u003c\/p\u003e\n\u003cp\u003e\u003cb\u003eDescription of some adverse reactions\u003c\/b\u003e \u003csup\u003e1\u003c\/sup\u003e Hematopoiesis disorders including anemia, aplastic anemia, hemolytic anemia (positive Coombs test), leukopenia, neutropenia, thrombocytopenia (with or without purpura), eosinophilia, pancytopenia, and agranulocytosis. The first symptoms may be: fever, sore throat, superficial mouth ulcers, flu-like symptoms, marked fatigue, nosebleeds and bleeding. Rarely congestive heart failure in patients with impaired cardiac function. ² Hypersensitivity reactions: these reactions include a) non-specific allergic reactions and anaphylaxis, fever, chills, b) respiratory tract reactivity including asthma, aggravated asthma, bronchospasm (see section 4.3 and 4.4) or dyspnoea or c) various skin conditions including various skin rashes (including maculopapular in nature), pruritus, urticaria with or without angioedema, purpura, angioedema and much rarely, bullous and exfoliative dermatitis including toxic epidermal necrolysis, Stevens-Johnson syndrome and erythema multiforme. ³ Decreased appetite: generally resolves rapidly upon discontinuation of treatment (see section 4.4). \u003csup\u003e4.\u003c\/sup\u003e The pathogenetic mechanism of drug-induced aseptic meningitis is not completely known. However, the data available on aseptic meningitis related to the administration of NSAIDs leads us to think of an immune reaction (due to a temporal relationship with the intake of the medicine and the disappearance of symptoms after discontinuation of treatment). Of note, individual cases of symptoms of aseptic meningitis (such as stiff neck, neck numbness, headache, nausea, vomiting, fever and disorientation) have been observed during treatment with ibuprofen in patients with autoimmune diseases (such as systemic lupus erythromatosus, mixed connective tissue disease). \u003csup\u003e5\u003c\/sup\u003e Heart failure and edema: Clinical studies and epidemiological data suggest that the use of ibuprofen, especially at high doses (2400 mg\/day) and for long-term treatments, may be associated with a modest increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke) (see section 4.4). Congestive heart failure in patients with impaired cardiac function. \u003csup\u003e6\u003c\/sup\u003e The most commonly observed adverse events are gastrointestinal in nature. Gastric discomfort can be reduced by taking the medicine on a full stomach. \u003csup\u003e7\u003c\/sup\u003e Peptic ulcers, gastrointestinal perforation or hemorrhage, melena, and sometimes fatal hematemesis may occur. \u003csup\u003e8\u003c\/sup\u003e Exacerbation of colitis and Crohn's disease (see section 4.4). \u003csup\u003e9\u003c\/sup\u003e Acute renal failure especially in case of long-term therapy, associated with increased serum urea levels and edema. Papillary necrosis may occur. \u003cb\u003eReporting of suspected adverse reactions\u003c\/b\u003e Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit\/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at: https:\/\/www.aifa.gov.it\/content\/segnalazioni-reazioni-avverse.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eOVERDOSE\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cu\u003eToxicity \u003c\/u\u003e Signs and symptoms of toxicity were generally not observed at doses below 100 mg\/kg in children or adults. However, in some cases supportive treatment may be necessary. Children have been observed to exhibit signs and symptoms of toxicity after ingesting ibuprofen at doses of 400 mg\/kg or greater. The half-life of the drug in case of overdose is 1.5-3 hours. \u003cu\u003eSymptoms \u003c\/u\u003e Most patients who accidentally ingest clinically relevant quantities of ibuprofen will experience symptoms within 4 to 6 hours. The most commonly reported overdose symptoms include: nausea, vomiting, abdominal pain, lethargy, and drowsiness. Central nervous system (CNS) effects include headache, tinnitus, dizziness, seizures, and loss of consciousness. Nystagmus, metabolic acidosis, hypothermia, renal effects, gastrointestinal bleeding, coma, apnea, diarrhea and CNS and respiratory depression have also been reported rarely. Disorientation, arousal, fainting and cardiovascular toxicity including hypotension, bradycardia and tachycardia have been reported. In cases of significant overdose, renal failure and liver damage are possible. In cases of severe poisoning, metabolic acidosis and a prolongation of the prothrombin time (INR) may occur, probably caused by interference with the action of coagulation factors present in the circulation. In asthmatic subjects, an exacerbation of the symptoms of the disease may occur. \u003cu\u003eTreatment \u003c\/u\u003e There is no specific antidote for ibuprofen overdose. In case of overdose, symptomatic and supportive treatment is therefore indicated and must include maintaining a patent airway and monitoring cardiac function and vital signs until the patient is stabilised. Particular attention is due to the control of blood pressure, acid-base balance and any gastrointestinal bleeding. Administration of activated charcoal should be considered within one hour of ingesting a potentially toxic quantity. Alternatively, in adults, gastric lavage should be considered within one hour of ingestion of a potentially life-threatening overdose. Adequate diuresis must be ensured and renal and hepatic functions must be closely monitored. The patient must remain under observation for at least four hours following ingestion of a potentially toxic amount of drug. Any occurrence of frequent or prolonged convulsions should be treated with intravenous diazepam or lorazepam. If ibuprofen has already been absorbed, alkaline substances should be administered to promote excretion of the acidic ibuprofen in the urine. Administer bronchodilators in case of asthma. Depending on the patient's clinical condition, other support measures may be necessary. For more information, contact your local poison control center.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003ePREGNANCY AND BREASTFEEDING\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eChildren under the age of 12 are unlikely to become pregnant or breastfeed. Furthermore, in such circumstances the following considerations must be kept in mind. \u003cu\u003ePregnancy \u003c\/u\u003e During the first and second trimesters of pregnancy, administration of ibuprofen should be avoided. Ibuprofen is contraindicated during the third trimester of pregnancy. Inhibition of prostaglandin synthesis can negatively affect pregnancy and\/or embryo\/foetal development. Results of epidemiological studies suggest an increased risk of miscarriage and cardiac malformation and gastroschisis after the use of a prostaglandin synthesis inhibitor in the early stages of pregnancy. The absolute risk of cardiac malformations increased from less than 1% to approximately 1.5%. The risk was thought to increase with the dose and duration of therapy. In animals, the administration of prostaglandin synthesis inhibitors has been shown to cause an increase in pre- and post-implantation loss and embryo-foetal mortality. Furthermore, an increased incidence of various malformations, including cardiovascular malformations, has been reported in animals administered prostaglandin synthesis inhibitors during the organogenetic period. During the third trimester of pregnancy, all inhibitors of prostaglandin synthesis can expose the fetus to: - cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension); - renal dysfunction which may progress to renal failure with oligo-hydramnios; the mother and the newborn, at the end of pregnancy, to: - possible prolongation of bleeding time, an anti-aggregating effect which can occur even at very low doses; - inhibition of uterine contractions resulting in delayed or prolonged labor. \u003cu\u003eBreastfeeding \u003c\/u\u003e There is limited data showing that ibuprofen can pass in low concentrations into breast milk and is unlikely to have any adverse effects on newborns.\u003cu\u003eFertility \u003c\/u\u003e There is evidence that medicinal products that inhibit the synthesis of cyclooxygenase\/prostaglandins can cause a weakening of female fertility by affecting ovulation. This effect is reversible after discontinuation of treatment. The administration of Nurofen should be suspended in women who have fertility problems or who are undergoing fertility investigations.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eEFFECTS ON DRIVING ABILITY\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eFor short periods of treatment, Nurofen Fever and Pain does not or negligibly alter the ability to drive and use machinery.\u003c\/p\u003e","brand":"Reckitt Benckiser","offers":[{"title":"Default Title","offer_id":51131206107463,"sku":"034102386","price":16.91,"currency_code":"EUR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0564\/4989\/2467\/files\/reckitt-benckiser-h-it-spa-nurofen-febbre-e-dolore-200mg-5ml-sospensione-orale-gusto-fragola-senza-zucchero-100ml-farmacia-dottor-tili-1213792372.jpg?v=1767142149"},{"product_id":"nurofen-influenza-e-raffreddore-200mg-30mg-12-compresse-rivestite","title":"Nurofen Cold and Flu 200mg + 30mg 12 coated tablets","description":"\u003cp\u003e\u003cstrong\u003eINDICATIONS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eNUROFEN FLU AND COLDS 200 mg + 30 mg Coated Tablets, is indicated in adults and adolescents over 12 years of age. Treatment of cold and flu symptoms such as nasal and sinus congestion, pain, fever, sore throat, headache.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eACTIVE INGREDIENTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eOne tablet contains: Ibuprofen 200 mg, Pseudoephedrine hydrochloride 30 mg Excipients with known effects: sodium, sunset yellow FCF (E 110). For the full list of excipients, see section 6.1.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eEXCIPIENTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eTricalcium phosphate, sodium carboxymethylcellulose, microcrystalline cellulose, povidone, methylhydroxypropylcellulose, magnesium stearate, talc, colourants: E 104, E 110, E 171.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eCONTRAINDICATIONS AND SIDE EFFECTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eHypersensitivity to the active substances or to any of the excipients listed in paragraph 6.1. Patients suffering from peptic ulcer. History of gastrointestinal hemorrhage or perforation related to previous active treatments or history of recurrent hemorrhage\/peptic ulcer (two or more distinct episodes of demonstrated ulceration or bleeding). Subjects who have previously shown hypersensitivity reactions (such as nasal polyposis, asthma, rhinitis, angioedema or urticaria) following the use of ibuprofen, acetylsalicylic acid or other analgesics, antipyretics, other non-steroidal anti-inflammatory drugs (NSAIDs). Severe kidney or liver failure. Severe heart failure (NYHA class IV) Patients with serious cardiovascular diseases, tachycardia, hypertension, angina pectoris, hyperthyroidism, diabetes, pheochromocytoma, glaucoma, prostatic syndrome. Pregnancy. Breastfeeding (see section 4.6). Children under 12 years old. Patients taking or have taken monoamine oxidase inhibitors (MAOIs) in the previous 14 days (see section 4.5).\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eDOSAGE\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cu\u003eDosage\u003c\/u\u003e Only for a short period of treatment. • maximum 5 days of therapy for the adult population; • 3 days maximum therapy for the pediatric population (12-18 years). Undesirable effects can be minimized by using the lowest effective dose for the shortest possible treatment duration needed to control symptoms (see section 4.4). If the use of the medicine is necessary for more than 5 days in adults and for more than 3 days in adolescents, or in the case of worsening of symptoms, the doctor should be consulted. \u003cu\u003ePediatric population\u003c\/u\u003e: Do not administer to children under 12 years of age \u003cu\u003eAdults and adolescents over 12 years old\u003c\/u\u003e: The initial dose is 1-2 tablets per day, then, if necessary, 1-2 tablets every 4 hours. Do not exceed the dose of 6 tablets in 24 hours. \u003cu\u003eElderly\u003c\/u\u003e: No changes to the recommended dosage are required in the elderly except in patients with renal or hepatic alterations for whom it is necessary to individually adapt the dosage. \u003cu\u003eMethod of administration\u003c\/u\u003e: Oral use.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eCONSERVATION\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eThis medicinal product does not require any special storage conditions.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eWARNINGS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eSide effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see section 4.2 and the sections below on Gastrointestinal and Cardiovascular Risks). Other NSAIDs: the use of NUROFEN COLD AND FLU should be avoided in conjunction with NSAIDs, including selective COX-2 inhibitors. Avoid the simultaneous use of two or more analgesics, antipyretics, non-steroidal anti-inflammatory drugs, as this leads to an increased risk of side effects. The use of NSAIDs must be carefully evaluated in patients suffering from coagulation disorders as a reduction in coagulability is possible. The same applies to patients being treated with oral anticoagulants, due to the possibility of an enhancement of the anticoagulant effect (see also section 4.5). Gastrointestinal safety: as with all anti-inflammatories, the drug should not be taken if the patient suffers from ulcers or gastric disorders. Gastrointestinal haemorrhage, ulceration and perforation: Gastrointestinal haemorrhage, ulceration and perforation, which may be fatal, have been reported at any time during treatment with all NSAIDs, with or without warning symptoms or previous history of serious gastrointestinal events. In the elderly and in patients with a history of ulcer, especially if complicated by haemorrhage or perforation (see section 4.3), the risk of gastrointestinal haemorrhage, ulceration or perforation is higher with increased doses of NSAIDs. These patients should start treatment with the lowest available dose. The concomitant use of protective agents (misoprostol or proton pump inhibitors) should be considered for these patients and also for patients taking low doses of acetylsalicylic acid or other drugs that may increase the risk of gastrointestinal events (see section 4.5 below). Patients with a history of gastrointestinal toxicity, particularly the elderly, should report any unusual gastrointestinal symptoms (especially gastrointestinal bleeding) particularly in the initial stages of treatment. Caution should be exercised in patients taking concomitant medications that may increase the risk of ulceration or haemorrhage, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or antiplatelet agents such as acetylsalicylic acid (see section 4.5). When gastrointestinal bleeding or ulceration occurs in patients taking NUROFEN FLU AND COLDS, treatment should be discontinued. NSAIDs should be administered with caution to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated (see section 4.8). Cardiovascular and cerebrovascular effects: caution is required (discuss with your doctor or pharmacist) before starting treatment in patients with a positive history of hypertension and\/or heart failure since fluid retention, hypertension and edema have been found in association with treatment with NSAIDs. Clinical studies suggest that the use of ibuprofen, especially at high doses (2400 mg\/day), may be associated with a modest increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke). In general, epidemiological studies do not suggest that low doses of ibuprofen (e.g. ≤ 1200 mg\/day) are associated with an increased risk of arterial thrombotic events. Patients with uncontrolled hypertension, congestive heart failure (NYHA class II-III), established ischemic heart disease, peripheral arterial disease and\/or cerebrovascular disease should be treated with ibuprofen only after careful consideration and high doses (2400 mg\/day) should be avoided. Be careful consideration must also be exercised before starting long-term treatment for patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidemia, diabetes mellitus, cigarette smoking habit), especially if high doses (2400 mg\/day) of ibuprofen are necessary. Skin reactions: Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and Toxic Epidermal Necrolysis, have been reported very rarely in association with the use of NSAIDs (see section 4.8). In the early stages of therapy, patients appear to be at higher risk: the onset of the reaction occurs in most cases in the early stages of treatment. NUROFEN FLU AND COLDS should be discontinued at the first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity. Severe skin reactions: Severe skin reactions, such as acute generalized exanthematous pustulosis (PEAG), may occur with medicines containing ibuprofen and pseudoephedrine. This acute pustular eruption may occur within the first 2 days of treatment, with fever and numerous, small, mostly non-follicular pustules resulting from a widespread edematous erythema and localized mainly on the skin folds, trunk and upper limbs. Patients should be carefully monitored. If signs and symptoms such as pyrexia, erythema or numerous small pustules are observed, the administration of Nurofen Flu and Cold should be stopped and appropriate measures taken if necessary. Respiratory disorders: bronchospasm may occur in patients with bronchial asthma or current or previous allergic diseases. Do not take the product in cases of asthma and allergy to acetylsalicylic acid unless after consulting your doctor (see paragraph 4.3). SLE and mixed connective tissue disease: in case of systemic lupus erythematosus and mixed connective tissue disease it may lead to an increased risk of aseptic meningitis (see section 4.8). Renal function: renal failure, as renal function may be impaired (see sections 4.3 and 4.8). Liver function: liver dysfunction (see sections 4.3 and 4.8). Impaired female fertility: see paragraph 4.6 regarding female fertility. To be used with caution in combination with antihypertensives including neuronal adrenergic blockers and beta blockers (see section 4.5). To be used with caution with other sympathomimetic agents such as decongestants, appetite suppressants and amphetamine psycho-stimulants (see section 4.5). To be used with caution in case of hyperexcitation. If hallucinations, restlessness or sleep disturbances occur during administration of the medicine, use of the medicine should be discontinued. Elderly: Elderly patients present a higher frequency of adverse reactions to NSAIDs, in particular gastrointestinal haemorrhage and perforation which can be fatal (see section 4.2). Pediatric population: In dehydrated adolescents there is a risk of impaired renal function. Ischemic colitis: Some cases of ischemic colitis have been reported with pseudoephedrine. If sudden abdominal pain, rectal bleeding, or other symptoms of ischemic colitis develop, pseudoephedrine should be discontinued and a physician should be consulted. \u003cu\u003eIschemic optic neuropathy\u003c\/u\u003e Cases of ischemic optic neuropathy have been reported with pseudoephedrine. Pseudoephedrine should be discontinued if sudden loss of vision or reduction in visual acuity occurs, for example in the case of a scotoma. \u003cu\u003eMasking of symptoms of underlying infections\u003c\/u\u003e Nurofen Flu and Cold can mask the symptoms of infection, which could delay starting appropriate treatment and therefore worsen the outcome of the infection. This has been observed in community-acquired bacterial pneumonia and bacterial complications of chickenpox. When Nurofen Flu and Cold is administered for the relief of fever or pain related to infection, monitoring of the infection is recommended. In non-hospital settings, the patient should seek medical attention if symptoms persist or worsen. This medicinal product contains: • less than 1 mmol (23 mg) of \u003cb\u003esodium\u003c\/b\u003e per tablet, i.e. essentially “sodium-free”; • \u003cb\u003esunset yellow dye FCF (E 110)\u003c\/b\u003e, which can cause allergic reactions.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eINTERACTIONS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eAnticoagulants: NSAIDs may increase the effects of anticoagulants, such as warfarin (see section 4.4). Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal haemorrhage (see section 4.4). Corticosteroids: increased risk of gastrointestinal ulceration or haemorrhage (see section 4.4). The product must not be taken by patients being treated with monoamine oxidase inhibitors and for 14 days following the cessation of such treatment. The product may enhance the effect of other sympathomimetic agents, such as decongestants. The effect of pseudoephedrine could be reduced by guanethidine, reserpine and methyldopa and could be influenced by tricyclic antidepressants. In turn, pseudoephedrine may reduce the effect of guanethidine and may increase the possibility of arrhythmias in digitized patients, or in patients taking anticholinergics (including tricyclic antidepressants) or quinidine. Diuretics, ACE inhibitors and Angiotensin II antagonists: NSAIDs can reduce the effect of diuretics and other antihypertensive drugs. In some patients with compromised renal function (e.g. dehydrated patients or elderly patients with compromised renal function) co-administration of an ACE inhibitor or an angiotensin II antagonist and agents that inhibit the cyclo-oxygenase system may lead to further deterioration of renal function, including possible acute renal failure, which is usually reversible. These interactions should be considered in patients taking NUROFEN FLU AND COLDS concomitantly with ACE inhibitors or angiotensin II antagonists. Therefore, the combination should be administered with caution, especially in elderly patients. Patients should be adequately hydrated and consideration should be given to monitoring renal function after initiation of concomitant therapy. Acetylsalicylic acid: concomitant administration of ibuprofen and acetylsalicylic acid is generally not recommended due to the potential for increased side effects (see section 4.4). Experimental data suggest that ibuprofen may competitively inhibit the effect of low-dose acetylsalicylic acid on platelet aggregation when the drugs are administered simultaneously. Although there are uncertainties regarding the extrapolation of these data to the clinical situation, the possibility cannot be excluded that regular, long-term use of ibuprofen may reduce the cardioprotective effect of acetylsalicylic acid at low doses. No relevant clinical effects are considered likely following occasional use of ibuprofen (see section 5.1). Other NSAIDs including selective cyclooxygenase-2 inhibitors: concomitant use of two or more NSAIDs should be avoided as it may increase the risk of adverse events (see section 4.4). Cardiac glucosides: NSAIDs can worsen heart failure, reduce GFR (glomerular filtration rate) and plasma levels of glucosides. Lithium. There is evidence of the possibility of a potential increase in lithium levels in the blood. Methotrexate. There is evidence of the possibility of an increase in plasma levels of methotrexate. Cyclosporins: increase the risk of nephrotoxicity. Mifepristone: NSAIDs cannot be administered for 8-12 days following administration of mifepristone as NSAIDs may reduce the effect of mifepristone. Tacrolimus: Possible increased risk of nephrotoxicity when NSAIDs are administered with tacrolimus. Zidovudine: Increased risk of hematological toxicity when NSAIDs are used concomitantly with Zidovudine. There is evidence of increased risk of hemarthrosis and hematoma in HIV-positive haemophilia patients if treated simultaneously with zidovudine and ibuprofen. Quinolone antibiotics: Data from animal studies indicate that NSAIDs may increase the risk of seizures associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may have an increased risk of developing seizures. Ergot alkaloids (ergotamine and methysergide): increased risk of ergotism. Appetite suppressants (anorectics) and amphetamine-like psychostimulants: risk of hypertension. Oxytocin: risk of hypertension\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eSIDE EFFECTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eThe list of the following side effects includes those that have been observed during treatment with ibuprofen at self-medication doses (up to a maximum of 1200mg per day) and with sympathomimetics including pseudoephedrine for short periods of administration. Side effects associated with the administration of ibuprofen and sympathomimetics such as pseudoephedrine are listed below according to system organ class and frequency. \u003ci\u003eFor the frequency of occurrence of side effects, the following expressions are used:\u003c\/i\u003e \u003ci\u003eVery common (\u003c\/i\u003e≥ \u003ci\u003e1\/10)\u003c\/i\u003e \u003ci\u003eMunicipality (\u003c\/i\u003e \u003csub\u003e≥ \u003c\/sub\u003e \u003ci\u003e1\/100, \u0026lt;1\/10)\u003c\/i\u003e \u003ci\u003eUncommon (\u003c\/i\u003e \u003csub\u003e≥ \u003c\/sub\u003e \u003ci\u003e1\/1000, \u0026lt;1\/100)\u003c\/i\u003e \u003ci\u003eRare (\u003c\/i\u003e \u003csub\u003e≥ \u003c\/sub\u003e \u003ci\u003e1\/10.000, \u0026lt;1\/1000)\u003c\/i\u003e \u003ci\u003eVery rare (\u003c1\/10,000)\u003c\/i\u003e \u003ci\u003eNot known (frequency cannot be estimated from the available data)\u003c\/i\u003e \u003ci\u003eWithin each frequency grouping, undesirable effects are presented in order of decreasing seriousness.\u003c\/i\u003e \u003cb\u003eTable of side effects\u003c\/b\u003e\u003c\/p\u003e\n\u003cp\u003eBlood and lymphatic system disorders - Frequency: Uncommon. Adverse Reaction: Hypersensitivity reactions characterized by urticaria and pruritus²\u003c\/p\u003e\n\u003cp\u003eBlood and lymphatic system disorders - Frequency: Very rare. Adverse Reaction: Hematopoietic disorders¹. Severe hypersensitivity reactions. Symptoms may be: swelling of the face, tongue and larynx, dyspnoea, tachycardia, hypotension (anaphylaxis, angioedema or severe shock).²\u003c\/p\u003e\n\u003cp\u003ePsychiatric disorders - Frequency: Not known. Adverse Reaction: Insomnia, anxiety, restlessness, agitation, hallucinations.\u003c\/p\u003e\n\u003cp\u003eNervous system disorders - Frequency: Uncommon. Adverse Reaction: Headache, tremors.\u003c\/p\u003e\n\u003cp\u003eNervous system disorders - Frequency: Very rare. Adverse Reaction: Aseptic meningitis³\u003c\/p\u003e\n\u003cp\u003eEye disorders - Frequency: Not known. Adverse Reaction: Ischemic optic neuropathy.\u003c\/p\u003e\n\u003cp\u003eCardiac disorders - Frequency: Not known. Adverse Reaction: Heart failure and edema4, tachycardia, chest pain, arrhythmia, palpitations.\u003c\/p\u003e\n\u003cp\u003eVascular disorders - Frequency: Not known. Adverse Reaction: Hypertension4.\u003c\/p\u003e\n\u003cp\u003eRespiratory, thoracic and mediastinal disorders - Frequency: Not known. Adverse Reaction: Reactivity of the respiratory system including asthma, bronchospasm or dyspnoea²\u003c\/p\u003e\n\u003cp\u003eGastrointestinal disorders - Frequency: Uncommon. Adverse Reaction: Abdominal pain, nausea and dyspepsia5.\u003c\/p\u003e\n\u003cp\u003eGastrointestinal disorders - Frequency: Rare. Adverse Reaction: Diarrhoea, flatulence, constipation and vomiting.\u003c\/p\u003e\n\u003cp\u003eGastrointestinal disorders - Frequency: Very rare. Adverse Reaction: Peptic ulcer, gastrointestinal perforation or haemorrhage, melena, haematemesis, sometimes fatal, particularly in the elderly (see section 4.4). Ulcerative stomatitis, mouth ulcerations, gastritis.\u003c\/p\u003e\n\u003cp\u003eGastrointestinal disorders - Frequency: Not known. Adverse Reaction: Dry mouth. Exacerbation of colitis and Crohn's disease (see section 4.4). Ischemic colitis.\u003c\/p\u003e\n\u003cp\u003eHepatobiliary disorders - Frequency: Very rare. Adverse Reaction: Liver disorders.\u003c\/p\u003e\n\u003cp\u003eSkin and subcutaneous tissue disorders - Frequency: Uncommon. Adverse Reaction: Skin rashes ²\u003c\/p\u003e\n\u003cp\u003eSkin and subcutaneous tissue disorders - Frequency: Very rare. Adverse Reaction: Bullous reactions including Stevens-Johnson syndrome, erythema multiforme and Toxic Epidermal Necrolysis may occur.\u003c\/p\u003e\n\u003cp\u003eSkin and subcutaneous tissue disorders - Frequency: Not known. Adverse Reaction: Hyperhidrosis. Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome). Severe skin reactions, including acute generalized exanthematous pustulosis (PEAG). Photosensitivity reactions\u003c\/p\u003e\n\u003cp\u003eMusculoskeletal system and connective tissue disorders - Frequency: Not known. Adverse Reaction: Muscle weakness.\u003c\/p\u003e\n\u003cp\u003eRenal and urinary disorders - Frequency: Very rare. Adverse Reaction: Severe renal failure 6.\u003c\/p\u003e\n\u003cp\u003eRenal and urinary disorders - Frequency: Not known. Adverse Reaction: Urinary retention.\u003c\/p\u003e\n\u003cp\u003eGeneral disorders and conditions relating to the administration site - Frequency: Not known. Adverse Reaction: Irritability, thirst.\u003c\/p\u003e\n\u003cp\u003eDiagnostic tests - Frequency: Very rare. Adverse Reaction: Decreased hemoglobin level in the blood.\u003c\/p\u003e\n\u003cp\u003e\u003cb\u003eDescription of some side effects\u003c\/b\u003e 1) Examples of hematopoietic disorders include anemia, leukopenia, thrombocytopenia, pancytopenia, and agranulocytosis. The first symptoms are fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe feeling of tiredness, unexplained bleeding and bruising. 2) Hypersensitivity reactions: these reactions include a) non-specific allergic reactions and anaphylaxis, b) respiratory tract reactivity including asthma, worsening of asthma, bronchospasm or dyspnoea or c) various skin conditions such as various skin rashes, pruritus, urticaria, purpura, angioedema and very rarely bullous and exfoliative dermatitis including toxic epidermal necrolysis, Stevens-Johnson syndrome and erythema multiforme, d) cross-reactivity reactions with pseudoephedrine 3) The pathogenesis of drug-induced aseptic meningitis is not completely known. However, the data available on aseptic meningitis related to the administration of NSAIDs leads us to think of an immune hypersensitivity reaction (due to a temporary relationship with the intake of the medicine and the disappearance of symptoms after discontinuation of treatment). Of note, individual cases of aseptic meningitis symptoms (such as stiff neck, headache, nausea, vomiting, fever and disorientation) have been observed during treatment with ibuprofen in patients with autoimmune disorders (such as systemic lupus erythematosus, mixed connective tissue disease). 4) Clinical studies suggest that the use of ibuprofen, especially at high doses (2400 mg\/day) may be associated with a modest increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke) (see section 4.4) 5) Gastrointestinal: the most commonly observed adverse events are gastrointestinal in nature. Peptic ulcers, perforation or gastrointestinal haemorrhage, sometimes fatal, may occur, particularly in the elderly (see section 4.4). 6) Especially during long treatments, associated with an increase in serum urea and edema. Also includes papillary necrosis. Gastrointestinal intolerance, bleeding, sweating, dizziness, precordial pain, difficulty urinating and insomnia may occur. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit\/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at: https:\/\/www.aifa.gov.it\/content\/segnalazioni-reazioniavverse.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eOVERDOSE\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cu\u003eSymptoms\u003c\/u\u003e Nausea, vomiting, abdominal pain and more rarely diarrhea may occur. Tinnitus, headaches and gastrointestinal bleeding may also occur. In more severe cases of poisoning, central nervous system toxicity is observed, manifested by dizziness, drowsiness, occasionally excitation and disorientation or coma. Occasionally patients develop seizures. In cases of severe poisoning, metabolic acidosis and a prolongation of the prothrombin time\/INR may occur, probably caused by interference with the action of coagulation factors present in the circulation. Acute renal failure, liver damage and respiratory depression may also occur. In asthmatic subjects, asthma exacerbation may occur. As with other sympathomimetics, an excessive dose of pseudoephedrine can cause symptoms related to central nervous system disorders and cardiovascular stimulation, including\u003cb\u003e:\u003c\/b\u003e irritability, restlessness, tremors, thirst, blurred vision, anxiety anxiety, insomnia, fever, sweating, exophthalmos, hallucinations, muscle weakness\u003cb\u003e,\u003c\/b\u003e palpitations, convulsions, urinary retention, hypertension, difficulty urinating, nausea, vomiting, tachycardia and cardiac arrhythmias. \u003cu\u003eTreatment\u003c\/u\u003e Treatment must be symptomatic and supportive, particularly of the cardiovascular and respiratory systems, and must include maintaining a patent airway and monitoring cardiac function and vital signs until the patient is stabilized. Oral administration of activated charcoal should be considered if the patient presents within 1 hour of ingesting a potentially toxic quantity. If necessary, corrective intervention of serum electrolytes should be used. Seizures should be treated with intravenous benzodiazepines if they are frequent or prolonged. Administer bronchodilators in case of asthma. The elimination of pseudoephedrine can be accelerated by acid diuresis or dialysis. Hypertensive phenomena can be treated with IV alpha receptor blocking drugs. Cardiac arrhythmias may require the use of beta-adrenergic blocking agents after administration of alpha-adrenergic blockers. Hyperexcitability and hallucinations can be treated with chlorpromazine.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003ePREGNANCY AND BREASTFEEDING\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eThe product should not be used during pregnancy and breastfeeding. \u003cb\u003ePregnancy:\u003c\/b\u003e Inhibition of prostaglandin synthesis can negatively affect pregnancy and\/or embryo\/foetal development. Results of epidemiological studies suggest an increased risk of miscarriage and cardiac malformation and gastroschisis after the use of a prostaglandin synthesis inhibitor in the early stages of pregnancy. The absolute risk of cardiac malformations increased from less than 1% to approximately 1.5%. The risk was thought to increase with the dose and duration of therapy. In animals, the administration of prostaglandin synthesis inhibitors has been shown to cause an increase in pre- and post-implantation loss and embryo-foetal mortality. Furthermore, an increased incidence of various malformations, including cardiovascular malformations, has been reported in animals to which prostaglandin synthesis inhibitors were administered during the organogenetic period. During the third trimester of pregnancy, all inhibitors of prostaglandin synthesis can expose the fetus to: - cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension); - renal dysfunction which may progress to renal failure with oligo-hydramnios; The mother and newborn, at the end of pregnancy, are exposed to: - possible prolongation of bleeding time, an anti-aggregating effect which can occur even at very low doses; - inhibition of uterine contractions resulting in delayed or prolonged labor. There is the possibility of an association between the onset of fetal anomalies and taking pseudoephedrine in the first trimester of pregnancy. \u003cb\u003eBreastfeeding:\u003c\/b\u003e Although ibuprofen is present in breast milk in very low concentrations, pseudoephedrine is secreted into milk in significant quantities; for this reason the product must not be used during breastfeeding. \u003cb\u003eFertility:\u003c\/b\u003e As with other NSAIDs, the use of NUROFEN FLU AND COLDS can alter female fertility due to its effect on ovulation. It is therefore not recommended in women wishing to conceive.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eEFFECTS ON DRIVING ABILITY\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eNot applicable\u003c\/p\u003e","brand":"Reckitt Benckiser","offers":[{"title":"Default Title","offer_id":51131232026951,"sku":"034246013","price":11.53,"currency_code":"EUR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0564\/4989\/2467\/files\/reckitt-benckiser-h-it-spa-nurofen-influenza-e-raffreddore-200mg-30mg-12-compresse-rivestite-farmacia-dottor-tili-1213792327.jpg?v=1767143169"},{"product_id":"nurofen-influenza-e-raffreddore-200mg-30mg-24-compresse-rivestite","title":"Nurofen Cold and Flu 200mg + 30mg 24 coated tablets","description":"\u003cp\u003e\u003cstrong\u003eINDICATIONS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eNUROFEN FLU AND COLDS 200 mg + 30 mg Coated Tablets, is indicated in adults and adolescents over 12 years of age. Treatment of cold and flu symptoms such as nasal and sinus congestion, pain, fever, sore throat, headache.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eACTIVE INGREDIENTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eOne tablet contains: Ibuprofen 200 mg, Pseudoephedrine hydrochloride 30 mg Excipients with known effects: sodium, sunset yellow FCF (E 110). For the full list of excipients, see section 6.1.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eEXCIPIENTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eTricalcium phosphate, sodium carboxymethylcellulose, microcrystalline cellulose, povidone, methylhydroxypropylcellulose, magnesium stearate, talc, colourants: E 104, E 110, E 171.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eCONTRAINDICATIONS AND SIDE EFFECTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eHypersensitivity to the active substances or to any of the excipients listed in paragraph 6.1. Patients suffering from peptic ulcer. History of gastrointestinal hemorrhage or perforation related to previous active treatments or history of recurrent hemorrhage\/peptic ulcer (two or more distinct episodes of demonstrated ulceration or bleeding). Subjects who have previously shown hypersensitivity reactions (such as nasal polyposis, asthma, rhinitis, angioedema or urticaria) following the use of ibuprofen, acetylsalicylic acid or other analgesics, antipyretics, other non-steroidal anti-inflammatory drugs (NSAIDs). Severe kidney or liver failure. Severe heart failure (NYHA class IV) Patients with serious cardiovascular diseases, tachycardia, hypertension, angina pectoris, hyperthyroidism, diabetes, pheochromocytoma, glaucoma, prostatic syndrome. Pregnancy. Breastfeeding (see section 4.6). Children under 12 years old. Patients taking or have taken monoamine oxidase inhibitors (MAOIs) in the previous 14 days (see section 4.5).\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eDOSAGE\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cu\u003eDosage\u003c\/u\u003e Only for a short period of treatment. • maximum 5 days of therapy for the adult population; • 3 days maximum therapy for the pediatric population (12-18 years). Undesirable effects can be minimized by using the lowest effective dose for the shortest possible treatment duration needed to control symptoms (see section 4.4). If the use of the medicine is necessary for more than 5 days in adults and for more than 3 days in adolescents, or in the case of worsening of symptoms, the doctor should be consulted. \u003cu\u003ePediatric population\u003c\/u\u003e: Do not administer to children under 12 years of age \u003cu\u003eAdults and adolescents over 12 years old\u003c\/u\u003e: The initial dose is 1-2 tablets per day, then, if necessary, 1-2 tablets every 4 hours. Do not exceed the dose of 6 tablets in 24 hours. \u003cu\u003eElderly\u003c\/u\u003e: No changes to the recommended dosage are required in the elderly except in patients with renal or hepatic alterations for whom it is necessary to individually adapt the dosage. \u003cu\u003eMethod of administration\u003c\/u\u003e: Oral use.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eCONSERVATION\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eThis medicinal product does not require any special storage conditions.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eWARNINGS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eSide effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see section 4.2 and the sections below on Gastrointestinal and Cardiovascular Risks). Other NSAIDs: the use of NUROFEN COLD AND FLU should be avoided in conjunction with NSAIDs, including selective COX-2 inhibitors. Avoid the simultaneous use of two or more analgesics, antipyretics, non-steroidal anti-inflammatory drugs, as this leads to an increased risk of side effects. The use of NSAIDs must be carefully evaluated in patients suffering from coagulation disorders as a reduction in coagulability is possible. The same applies to patients being treated with oral anticoagulants, due to the possibility of an enhancement of the anticoagulant effect (see also section 4.5). Gastrointestinal safety: as with all anti-inflammatories, the drug should not be taken if the patient suffers from ulcers or gastric disorders. Gastrointestinal haemorrhage, ulceration and perforation: Gastrointestinal haemorrhage, ulceration and perforation, which may be fatal, have been reported at any time during treatment with all NSAIDs, with or without warning symptoms or previous history of serious gastrointestinal events. In the elderly and in patients with a history of ulcer, especially if complicated by haemorrhage or perforation (see section 4.3), the risk of gastrointestinal haemorrhage, ulceration or perforation is higher with increased doses of NSAIDs. These patients should start treatment with the lowest available dose. The concomitant use of protective agents (misoprostol or proton pump inhibitors) should be considered for these patients and also for patients taking low doses of acetylsalicylic acid or other drugs that may increase the risk of gastrointestinal events (see section 4.5 below). Patients with a history of gastrointestinal toxicity, particularly the elderly, should report any unusual gastrointestinal symptoms (especially gastrointestinal bleeding) particularly in the initial stages of treatment. Caution should be exercised in patients taking concomitant medications that may increase the risk of ulceration or haemorrhage, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or antiplatelet agents such as acetylsalicylic acid (see section 4.5). When gastrointestinal bleeding or ulceration occurs in patients taking NUROFEN FLU AND COLDS, treatment should be discontinued. NSAIDs should be administered with caution to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated (see section 4.8). Cardiovascular and cerebrovascular effects: caution is required (discuss with your doctor or pharmacist) before starting treatment in patients with a positive history of hypertension and\/or heart failure since fluid retention, hypertension and edema have been found in association with treatment with NSAIDs. Clinical studies suggest that the use of ibuprofen, especially at high doses (2400 mg\/day), may be associated with a modest increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke). In general, epidemiological studies do not suggest that low doses of ibuprofen (e.g. ≤ 1200 mg\/day) are associated with an increased risk of arterial thrombotic events. Patients with uncontrolled hypertension, congestive heart failure (NYHA class II-III), established ischemic heart disease, peripheral arterial disease and\/or cerebrovascular disease should be treated with ibuprofen only after careful consideration and high doses (2400 mg\/day) should be avoided. Be careful consideration must also be exercised before starting long-term treatment for patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidemia, diabetes mellitus, cigarette smoking habit), especially if high doses (2400 mg\/day) of ibuprofen are necessary. Skin reactions: Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and Toxic Epidermal Necrolysis, have been reported very rarely in association with the use of NSAIDs (see section 4.8). In the early stages of therapy, patients appear to be at higher risk: the onset of the reaction occurs in most cases in the early stages of treatment. NUROFEN FLU AND COLDS should be discontinued at the first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity. Severe skin reactions: Severe skin reactions, such as acute generalized exanthematous pustulosis (PEAG), may occur with medicines containing ibuprofen and pseudoephedrine. This acute pustular eruption may occur within the first 2 days of treatment, with fever and numerous, small, mostly non-follicular pustules resulting from a widespread edematous erythema and localized mainly on the skin folds, trunk and upper limbs. Patients should be carefully monitored. If signs and symptoms such as pyrexia, erythema or numerous small pustules are observed, the administration of Nurofen Flu and Cold should be stopped and appropriate measures taken if necessary. Respiratory disorders: bronchospasm may occur in patients with bronchial asthma or current or previous allergic diseases. Do not take the product in cases of asthma and allergy to acetylsalicylic acid unless after consulting your doctor (see paragraph 4.3). SLE and mixed connective tissue disease: in case of systemic lupus erythematosus and mixed connective tissue disease it may lead to an increased risk of aseptic meningitis (see section 4.8). Renal function: renal failure, as renal function may be impaired (see sections 4.3 and 4.8). Liver function: liver dysfunction (see sections 4.3 and 4.8). Impaired female fertility: see paragraph 4.6 regarding female fertility. To be used with caution in combination with antihypertensives including neuronal adrenergic blockers and beta blockers (see section 4.5). To be used with caution with other sympathomimetic agents such as decongestants, appetite suppressants and amphetamine psycho-stimulants (see section 4.5). To be used with caution in case of hyperexcitation. If hallucinations, restlessness or sleep disturbances occur during administration of the medicine, use of the medicine should be discontinued. Elderly: Elderly patients present a higher frequency of adverse reactions to NSAIDs, in particular gastrointestinal haemorrhage and perforation which can be fatal (see section 4.2). Pediatric population: In dehydrated adolescents there is a risk of impaired renal function. Ischemic colitis: Some cases of ischemic colitis have been reported with pseudoephedrine. If sudden abdominal pain, rectal bleeding, or other symptoms of ischemic colitis develop, pseudoephedrine should be discontinued and a physician should be consulted. \u003cu\u003eIschemic optic neuropathy\u003c\/u\u003e Cases of ischemic optic neuropathy have been reported with pseudoephedrine. Pseudoephedrine should be discontinued if sudden loss of vision or reduction in visual acuity occurs, for example in the case of a scotoma. \u003cu\u003eMasking of symptoms of underlying infections\u003c\/u\u003e Nurofen Flu and Cold can mask the symptoms of infection, which could delay starting appropriate treatment and therefore worsen the outcome of the infection. This has been observed in community-acquired bacterial pneumonia and bacterial complications of chickenpox. When Nurofen Flu and Cold is administered for the relief of fever or pain related to infection, monitoring of the infection is recommended. In non-hospital settings, the patient should seek medical attention if symptoms persist or worsen. This medicinal product contains: • less than 1 mmol (23 mg) of \u003cb\u003esodium\u003c\/b\u003e per tablet, i.e. essentially “sodium-free”; • \u003cb\u003esunset yellow dye FCF (E 110)\u003c\/b\u003e, which can cause allergic reactions.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eINTERACTIONS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eAnticoagulants: NSAIDs may increase the effects of anticoagulants, such as warfarin (see section 4.4). Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal haemorrhage (see section 4.4). Corticosteroids: increased risk of gastrointestinal ulceration or haemorrhage (see section 4.4). The product must not be taken by patients being treated with monoamine oxidase inhibitors and for 14 days following the cessation of such treatment. The product may enhance the effect of other sympathomimetic agents, such as decongestants. The effect of pseudoephedrine could be reduced by guanethidine, reserpine and methyldopa and could be influenced by tricyclic antidepressants. In turn, pseudoephedrine may reduce the effect of guanethidine and may increase the possibility of arrhythmias in digitized patients, or in patients taking anticholinergics (including tricyclic antidepressants) or quinidine. Diuretics, ACE inhibitors and Angiotensin II antagonists: NSAIDs can reduce the effect of diuretics and other antihypertensive drugs. In some patients with compromised renal function (e.g. dehydrated patients or elderly patients with compromised renal function) co-administration of an ACE inhibitor or an angiotensin II antagonist and agents that inhibit the cyclo-oxygenase system may lead to further deterioration of renal function, including possible acute renal failure, which is usually reversible. These interactions should be considered in patients taking NUROFEN FLU AND COLDS concomitantly with ACE inhibitors or angiotensin II antagonists. Therefore, the combination should be administered with caution, especially in elderly patients. Patients should be adequately hydrated and consideration should be given to monitoring renal function after initiation of concomitant therapy. Acetylsalicylic acid: concomitant administration of ibuprofen and acetylsalicylic acid is generally not recommended due to the potential for increased side effects (see section 4.4). Experimental data suggest that ibuprofen may competitively inhibit the effect of low-dose acetylsalicylic acid on platelet aggregation when the drugs are administered simultaneously. Although there are uncertainties regarding the extrapolation of these data to the clinical situation, the possibility cannot be excluded that regular, long-term use of ibuprofen may reduce the cardioprotective effect of acetylsalicylic acid at low doses. No relevant clinical effects are considered likely following occasional use of ibuprofen (see section 5.1). Other NSAIDs including selective cyclooxygenase-2 inhibitors: concomitant use of two or more NSAIDs should be avoided as it may increase the risk of adverse events (see section 4.4). Cardiac glucosides: NSAIDs can worsen heart failure, reduce GFR (glomerular filtration rate) and plasma levels of glucosides. Lithium. There is evidence of the possibility of a potential increase in lithium levels in the blood. Methotrexate. There is evidence of the possibility of an increase in plasma levels of methotrexate. Cyclosporins: increase the risk of nephrotoxicity. Mifepristone: NSAIDs cannot be administered for 8-12 days following administration of mifepristone as NSAIDs may reduce the effect of mifepristone. Tacrolimus: Possible increased risk of nephrotoxicity when NSAIDs are administered with tacrolimus. Zidovudine: Increased risk of hematological toxicity when NSAIDs are used concomitantly with Zidovudine. There is evidence of increased risk of hemarthrosis and hematoma in HIV-positive haemophilia patients if treated simultaneously with zidovudine and ibuprofen. Quinolone antibiotics: Data from animal studies indicate that NSAIDs may increase the risk of seizures associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may have an increased risk of developing seizures. Ergot alkaloids (ergotamine and methysergide): increased risk of ergotism. Appetite suppressants (anorectics) and amphetamine-like psychostimulants: risk of hypertension. Oxytocin: risk of hypertension\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eSIDE EFFECTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eThe list of the following side effects includes those that have been observed during treatment with ibuprofen at self-medication doses (up to a maximum of 1200mg per day) and with sympathomimetics including pseudoephedrine for short periods of administration. Side effects associated with the administration of ibuprofen and sympathomimetics such as pseudoephedrine are listed below according to system organ class and frequency. \u003ci\u003eFor the frequency of occurrence of side effects, the following expressions are used:\u003c\/i\u003e \u003ci\u003eVery common (\u003c\/i\u003e≥ \u003ci\u003e1\/10)\u003c\/i\u003e \u003ci\u003eMunicipality (\u003c\/i\u003e \u003csub\u003e≥ \u003c\/sub\u003e \u003ci\u003e1\/100, \u0026lt;1\/10)\u003c\/i\u003e \u003ci\u003eUncommon (\u003c\/i\u003e \u003csub\u003e≥ \u003c\/sub\u003e \u003ci\u003e1\/1000, \u0026lt;1\/100)\u003c\/i\u003e \u003ci\u003eRare (\u003c\/i\u003e \u003csub\u003e≥ \u003c\/sub\u003e \u003ci\u003e1\/10.000, \u0026lt;1\/1000)\u003c\/i\u003e \u003ci\u003eVery rare (\u003c1\/10,000)\u003c\/i\u003e \u003ci\u003eNot known (frequency cannot be estimated from the available data)\u003c\/i\u003e \u003ci\u003eWithin each frequency grouping, undesirable effects are presented in order of decreasing seriousness.\u003c\/i\u003e \u003cb\u003eTable of side effects\u003c\/b\u003e\u003c\/p\u003e\n\u003cp\u003eBlood and lymphatic system disorders - Frequency: Uncommon. Adverse Reaction: Hypersensitivity reactions characterized by urticaria and pruritus²\u003c\/p\u003e\n\u003cp\u003eBlood and lymphatic system disorders - Frequency: Very rare. Adverse Reaction: Hematopoietic disorders¹. Severe hypersensitivity reactions. Symptoms may be: swelling of the face, tongue and larynx, dyspnoea, tachycardia, hypotension (anaphylaxis, angioedema or severe shock).²\u003c\/p\u003e\n\u003cp\u003ePsychiatric disorders - Frequency: Not known. Adverse Reaction: Insomnia, anxiety, restlessness, agitation, hallucinations.\u003c\/p\u003e\n\u003cp\u003eNervous system disorders - Frequency: Uncommon. Adverse Reaction: Headache, tremors.\u003c\/p\u003e\n\u003cp\u003eNervous system disorders - Frequency: Very rare. Adverse Reaction: Aseptic meningitis³\u003c\/p\u003e\n\u003cp\u003eEye disorders - Frequency: Not known. Adverse Reaction: Ischemic optic neuropathy.\u003c\/p\u003e\n\u003cp\u003eCardiac disorders - Frequency: Not known. Adverse Reaction: Heart failure and edema4, tachycardia, chest pain, arrhythmia, palpitations.\u003c\/p\u003e\n\u003cp\u003eVascular disorders - Frequency: Not known. Adverse Reaction: Hypertension4.\u003c\/p\u003e\n\u003cp\u003eRespiratory, thoracic and mediastinal disorders - Frequency: Not known. Adverse Reaction: Reactivity of the respiratory system including asthma, bronchospasm or dyspnoea²\u003c\/p\u003e\n\u003cp\u003eGastrointestinal disorders - Frequency: Uncommon. Adverse Reaction: Abdominal pain, nausea and dyspepsia5.\u003c\/p\u003e\n\u003cp\u003eGastrointestinal disorders - Frequency: Rare. Adverse Reaction: Diarrhoea, flatulence, constipation and vomiting.\u003c\/p\u003e\n\u003cp\u003eGastrointestinal disorders - Frequency: Very rare. Adverse Reaction: Peptic ulcer, gastrointestinal perforation or haemorrhage, melena, haematemesis, sometimes fatal, particularly in the elderly (see section 4.4). Ulcerative stomatitis, mouth ulcerations, gastritis.\u003c\/p\u003e\n\u003cp\u003eGastrointestinal disorders - Frequency: Not known. Adverse Reaction: Dry mouth. Exacerbation of colitis and Crohn's disease (see section 4.4). Ischemic colitis.\u003c\/p\u003e\n\u003cp\u003eHepatobiliary disorders - Frequency: Very rare. Adverse Reaction: Liver disorders.\u003c\/p\u003e\n\u003cp\u003eSkin and subcutaneous tissue disorders - Frequency: Uncommon. Adverse Reaction: Skin rashes ²\u003c\/p\u003e\n\u003cp\u003eSkin and subcutaneous tissue disorders - Frequency: Very rare. Adverse Reaction: Bullous reactions including Stevens-Johnson syndrome, erythema multiforme and Toxic Epidermal Necrolysis may occur.\u003c\/p\u003e\n\u003cp\u003eSkin and subcutaneous tissue disorders - Frequency: Not known. Adverse Reaction: Hyperhidrosis. Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome). Severe skin reactions, including acute generalized exanthematous pustulosis (PEAG). Photosensitivity reactions\u003c\/p\u003e\n\u003cp\u003eMusculoskeletal system and connective tissue disorders - Frequency: Not known. Adverse Reaction: Muscle weakness.\u003c\/p\u003e\n\u003cp\u003eRenal and urinary disorders - Frequency: Very rare. Adverse Reaction: Severe renal failure 6.\u003c\/p\u003e\n\u003cp\u003eRenal and urinary disorders - Frequency: Not known. Adverse Reaction: Urinary retention.\u003c\/p\u003e\n\u003cp\u003eGeneral disorders and conditions relating to the administration site - Frequency: Not known. Adverse Reaction: Irritability, thirst.\u003c\/p\u003e\n\u003cp\u003eDiagnostic tests - Frequency: Very rare. Adverse Reaction: Decreased hemoglobin level in the blood.\u003c\/p\u003e\n\u003cp\u003e\u003cb\u003eDescription of some side effects\u003c\/b\u003e 1) Examples of hematopoietic disorders include anemia, leukopenia, thrombocytopenia, pancytopenia, and agranulocytosis. The first symptoms are fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe feeling of tiredness, unexplained bleeding and bruising. 2) Hypersensitivity reactions: these reactions include a) non-specific allergic reactions and anaphylaxis, b) respiratory tract reactivity including asthma, worsening of asthma, bronchospasm or dyspnoea or c) various skin conditions such as various skin rashes, pruritus, urticaria, purpura, angioedema and very rarely bullous and exfoliative dermatitis including toxic epidermal necrolysis, Stevens-Johnson syndrome and erythema multiforme, d) cross-reactivity reactions with pseudoephedrine 3) The pathogenesis of drug-induced aseptic meningitis is not completely known. However, the data available on aseptic meningitis related to the administration of NSAIDs leads us to think of an immune hypersensitivity reaction (due to a temporary relationship with the intake of the medicine and the disappearance of symptoms after discontinuation of treatment). Of note, individual cases of aseptic meningitis symptoms (such as stiff neck, headache, nausea, vomiting, fever and disorientation) have been observed during treatment with ibuprofen in patients with autoimmune disorders (such as systemic lupus erythematosus, mixed connective tissue disease). 4) Clinical studies suggest that the use of ibuprofen, especially at high doses (2400 mg\/day) may be associated with a modest increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke) (see section 4.4) 5) Gastrointestinal: the most commonly observed adverse events are gastrointestinal in nature. Peptic ulcers, perforation or gastrointestinal haemorrhage, sometimes fatal, may occur, particularly in the elderly (see section 4.4). 6) Especially during long treatments, associated with an increase in serum urea and edema. Also includes papillary necrosis. Gastrointestinal intolerance, bleeding, sweating, dizziness, precordial pain, difficulty urinating and insomnia may occur. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit\/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at: https:\/\/www.aifa.gov.it\/content\/segnalazioni-reazioniavverse.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eOVERDOSE\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cu\u003eSymptoms\u003c\/u\u003e Nausea, vomiting, abdominal pain and more rarely diarrhea may occur. Tinnitus, headaches and gastrointestinal bleeding may also occur. In more severe cases of poisoning, central nervous system toxicity is observed, manifested by dizziness, drowsiness, occasionally excitation and disorientation or coma. Occasionally patients develop seizures. In cases of severe poisoning, metabolic acidosis and a prolongation of the prothrombin time\/INR may occur, probably caused by interference with the action of coagulation factors present in the circulation. Acute renal failure, liver damage and respiratory depression may also occur. In asthmatic subjects, asthma exacerbation may occur. As with other sympathomimetics, an excessive dose of pseudoephedrine can cause symptoms related to central nervous system disorders and cardiovascular stimulation, including\u003cb\u003e:\u003c\/b\u003e irritability, restlessness, tremors, thirst, blurred vision, anxiety anxiety, insomnia, fever, sweating, exophthalmos, hallucinations, muscle weakness\u003cb\u003e,\u003c\/b\u003e palpitations, convulsions, urinary retention, hypertension, difficulty urinating, nausea, vomiting, tachycardia and cardiac arrhythmias. \u003cu\u003eTreatment\u003c\/u\u003e Treatment must be symptomatic and supportive, particularly of the cardiovascular and respiratory systems, and must include maintaining a patent airway and monitoring cardiac function and vital signs until the patient is stabilized. Oral administration of activated charcoal should be considered if the patient presents within 1 hour of ingesting a potentially toxic quantity. If necessary, corrective intervention of serum electrolytes should be used. Seizures should be treated with intravenous benzodiazepines if they are frequent or prolonged. Administer bronchodilators in case of asthma. The elimination of pseudoephedrine can be accelerated by acid diuresis or dialysis. Hypertensive phenomena can be treated with IV alpha receptor blocking drugs. Cardiac arrhythmias may require the use of beta-adrenergic blocking agents after administration of alpha-adrenergic blockers. Hyperexcitability and hallucinations can be treated with chlorpromazine.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003ePREGNANCY AND BREASTFEEDING\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eThe product should not be used during pregnancy and breastfeeding. \u003cb\u003ePregnancy:\u003c\/b\u003e Inhibition of prostaglandin synthesis can negatively affect pregnancy and\/or embryo\/foetal development. Results of epidemiological studies suggest an increased risk of miscarriage and cardiac malformation and gastroschisis after the use of a prostaglandin synthesis inhibitor in the early stages of pregnancy. The absolute risk of cardiac malformations increased from less than 1% to approximately 1.5%. The risk was thought to increase with the dose and duration of therapy. In animals, the administration of prostaglandin synthesis inhibitors has been shown to cause an increase in pre- and post-implantation loss and embryo-foetal mortality. Furthermore, an increased incidence of various malformations, including cardiovascular malformations, has been reported in animals to which prostaglandin synthesis inhibitors were administered during the organogenetic period. During the third trimester of pregnancy, all inhibitors of prostaglandin synthesis can expose the fetus to: - cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension); - renal dysfunction which may progress to renal failure with oligo-hydramnios; The mother and newborn, at the end of pregnancy, are exposed to: - possible prolongation of bleeding time, an anti-aggregating effect which can occur even at very low doses; - inhibition of uterine contractions resulting in delayed or prolonged labor. There is the possibility of an association between the onset of fetal anomalies and taking pseudoephedrine in the first trimester of pregnancy. \u003cb\u003eBreastfeeding:\u003c\/b\u003e Although ibuprofen is present in breast milk in very low concentrations, pseudoephedrine is secreted into milk in significant quantities; for this reason the product must not be used during breastfeeding. \u003cb\u003eFertility:\u003c\/b\u003e As with other NSAIDs, the use of NUROFEN FLU AND COLDS can alter female fertility due to its effect on ovulation. It is therefore not recommended in women wishing to conceive.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eEFFECTS ON DRIVING ABILITY\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eNot applicable\u003c\/p\u003e","brand":"Reckitt Benckiser","offers":[{"title":"Default Title","offer_id":51131252539719,"sku":"034246025","price":18.51,"currency_code":"EUR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0564\/4989\/2467\/files\/reckitt-benckiser-h-it-spa-nurofen-influenza-e-raffreddore-200mg-30mg-24-compresse-rivestite-farmacia-dottor-tili-1213792309.jpg?v=1767143529"},{"product_id":"nurofen-febbre-e-dolore-200mg-5ml-sospensione-orale-gusto-arancia-100ml","title":"Nurofen Fever and Pain 200mg\/5ml oral suspension orange flavour 100ml","description":"\u003cp\u003e\u003cstrong\u003eINDICATIONS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eSymptomatic treatment of fever and mild or moderate pain.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eACTIVE INGREDIENTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eNUROFEN FEVER AND PAIN 200 mg\/5ml Oral Suspension Each ml of oral suspension contains active ingredient: ibuprofen 40 mg. Excipients with known effects: liquid maltitol, propylene glycol (present in the strawberry flavour), wheat starch (present in the orange flavour) and sodium. For the full list of excipients, see section 6.1.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eEXCIPIENTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cu\u003eNurofen Fever and Pain 200mg\/5ml oral suspension orange flavor without sugar \u003c\/u\u003e Polysorbate 80, glycerin, maltitol syrup, sodium saccharin, citric acid, sodium citrate, xanthan gum, sodium chloride, orange flavor, domiphene bromide, purified water. \u003cu\u003eNurofen Fever and Pain 200mg\/5ml oral suspension strawberry flavor without sugar \u003c\/u\u003e Polysorbate 80, glycerin, maltitol syrup, sodium saccharin, citric acid, sodium citrate, xanthan gum, sodium chloride, strawberry flavor, domiphene bromide, purified water.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eCONTRAINDICATIONS AND SIDE EFFECTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e• Hypersensitivity to ibuprofen or to any of the excipients listed in section 6.1. • Children under 2 years of age or weighing less than 10 kg. • The medicinal specialty is contraindicated in patients who show or have previously shown hypersensitivity (e.g. asthma, rhinitis, angioedema or urticaria) to acetylsalicylic acid or other analgesics, antipyretics, non-steroidal anti-inflammatory drugs (NSAIDs), in particular when hypersensitivity is associated with nasal polyposis and asthma. • Active peptic ulcer. • Severe renal or hepatic impairment (see section 4.4). • Severe heart failure (see section 4.4). • History of gastrointestinal bleeding or perforation related to previous NSAID-based therapy. • History of recurrent peptic hemorrhage\/ulcer (two or more distinct episodes of demonstrated ulceration or bleeding). • Concomitant use of NSAIDs, including specific COX-2 inhibitors. • During the last trimester of pregnancy (see section 4.6).\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eDOSAGE\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cu\u003eDosage \u003c\/u\u003e Undesirable effects can be minimized by using the lowest effective dose for the shortest possible treatment duration needed to control symptoms (see section 4.4). \u003cb\u003e \u003cu\u003eAdults and adolescents over 12 years old\u003c\/u\u003e (\u003c\/b\u003e \u003cu\u003e≥ 43 kg body weight)\u003c\/u\u003e: 200-400 mg of ibuprofen (corresponding to 5 - 10 ml of oral suspension), 2-3 times a day. The interval between doses should not be less than 4 hours. Do not exceed the maximum dose of 1200 mg (30 ml) in 24 hours. Use in adults is especially indicated in patients with dysphagia. \u003cb\u003e \u003cu\u003eElderly\u003c\/u\u003e:\u003c\/b\u003e No changes to the dosage schedule are required. \u003cb\u003e \u003cu\u003ePediatric population\u003c\/u\u003e \u003c\/b\u003e \u003cb\u003e \u003cu\u003eChildren between 2 - 12 years (10 - 43 kg body weight)\u003c\/u\u003e \u003c\/b\u003e The daily dose is structured based on the weight and age of the patient. The daily dose of 20-30 mg\/kg of body weight, divided 3 times a day at 6-8 hour intervals, can be administered based on the following schedule (do not exceed the recommended doses).\u003c\/p\u003e\n\u003cp\u003eWeight: From 10 Kg - Approximate age: 2 - 3 years. Single dose in ml: 2.5 ml. maximum number of administrations\/day: 3 in 24 hours.\u003c\/p\u003e\n\u003cp\u003eWeight: From 15 Kg - Approximate age: 4 - 6 years. Single dose in ml: 3.75 ml. maximum number of administrations\/day: 3 in 24 hours.\u003c\/p\u003e\n\u003cp\u003eWeight: From 20 kg - Approximate age: 7 - 9 years. Single dose in ml: 5 ml. maximum number of administrations\/day: 3 in 24 hours.\u003c\/p\u003e\n\u003cp\u003eWeight: From 28 to 43 Kg - Approximate age: 10 - 12 years. Single dose in ml: 7.5 ml. maximum number of administrations\/day: 3 in 24 hours.\u003c\/p\u003e\n\u003cp\u003eSpecial populations: in the case of post-vaccination fever, refer to the dosage indicated above, the administration of a single dose (2.5 ml) followed, if necessary, by another dose after 6 hours is recommended. Do not administer more than two doses in 24 hours. Consult your doctor if fever does not decrease. The product is intended for short-term treatments. If the use of the medicine is necessary for more than 3 days in children over 2 years of age, in adolescents and adults, or in the case of worsening of symptoms, a doctor should be consulted. \u003cu\u003eMethod of administration \u003c\/u\u003e Oral administration should take place using the measuring syringe or measuring spoon supplied with the product. The graduated scale on the body of the syringe highlights the marks for the different dosages: in particular the 2.5 ml mark corresponding to 100 mg of ibuprofen, the 3.75 ml mark corresponding to 150 mg of ibuprofen and the 5 ml mark corresponding to 200 mg of ibuprofen. The measuring spoon has two concave blades at the ends for the different doses: the 1.25 ml mark corresponding to 50 mg of ibuprofen, the 2.5 ml mark corresponding to 100 mg of ibuprofen and the 5 ml mark corresponding to 200 mg of ibuprofen. Patients suffering from stomach problems can take the medicine with meals. \u003cu\u003eInstructions for using the dosing syringe\u003c\/u\u003e: 1 - Unscrew the cap by pushing it downwards and turning it to the left. 2 - Insert the tip of the syringe fully into the hole in the undercap. 3 - Shake well. 4 - Turn the bottle upside down, then, holding the syringe firmly, gently pull the plunger downwards, allowing the suspension to flow into the syringe up to the mark corresponding to the desired dose. 5 - Put the bottle back in a vertical position and remove the syringe by rotating it gently. 6 - Introduce the tip of the syringe into your mouth and apply slight pressure on the plunger to let the suspension flow out. 7- After use, screw the cap to close the bottle and wash the syringe with hot water. Leave it to dry, keeping it out of the sight and reach of children.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eCONSERVATION\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eDo not store above 30°C.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eWARNINGS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eSide effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see paragraphs below on gastrointestinal and cardiovascular risks). The use of Nurofen Fever and Pain must be avoided in conjunction with NSAIDs, including selective COX-2 inhibitors. Analgesics, antipyretics, non-steroidal anti-inflammatory drugs can cause potentially serious hypersensitivity reactions (anaphylactoid reactions), even in subjects not previously exposed to this type of drugs. The risk of hypersensitivity reactions after taking ibuprofen is greater in subjects who have experienced such reactions after the use of other analgesics, antipyretics, non-steroidal anti-inflammatory drugs and in subjects with bronchial hyperreactivity (asthma), nasal polyposis or previous episodes of angioedema (see section 4.2 and section 4.8). Gastrointestinal haemorrhage, ulceration and perforation: Gastrointestinal haemorrhage, ulceration and perforation, which may be fatal, have been reported at any time during treatment with all NSAIDs, with or without warning symptoms or previous history of serious gastrointestinal events. In dehydrated children and adolescents there is a risk of impaired renal function (see sections 4.3 and 4.8). Elderly: Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which may be fatal (see section 4.2). In the elderly and in patients with a history of ulcer, especially if complicated by haemorrhage or perforation (see section 4.3), the risk of gastrointestinal haemorrhage, ulceration or perforation is higher with increased doses of NSAIDs. These patients should start treatment with the lowest available dose. The concomitant use of protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients and also for patients taking low doses of aspirin or other drugs that may increase the risk of gastrointestinal events (see section 4.5). Patients with a history of gastrointestinal toxicity, particularly the elderly, should report any unusual gastrointestinal symptoms (especially gastrointestinal haemorrhage) particularly in the initial stages of treatment. Caution should be exercised in patients taking concomitant medications that may increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or antiplatelet agents such as acetylsalicylic acid (aspirin) (see section 4.5). When gastrointestinal bleeding or ulceration occurs in patients taking Nurofen Fever and Pain, treatment should be discontinued. NSAIDs should be administered with caution to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated (see section 4.8). Severe skin reactions: Severe skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported rarely in association with the use of NSAIDs (see section 4.8). Patients appear to be at higher risk in the early stages of therapy: the onset of the reaction occurs in most cases within the first month of treatment. Acute generalized exanthematous pustulosis (PEAG) has been reported in connection with ibuprofen-containing medicinal products. Ibuprofen should be discontinued at the first appearance of signs and symptoms of severe skin reactions, such as rash, mucosal lesions or any other sign of hypersensitivity. Masking symptoms of underlying infections: Nurofen Fever and Pain may mask symptoms of infection, which could delay the start of adequate treatment and therefore worsen the outcome of the infection. This has been observed in community-acquired bacterial pneumonia and bacterial complications of chickenpox. When Nurofen Fever and Pain is administered for the relief of infection-related fever or pain, monitoring of the infection is advised. In non-hospital settings, the patient should seek medical attention if symptoms persist or worsen. Chickenpox can exceptionally cause serious infectious complications to the skin and soft tissues. To date, the contribution of NSAIDs in the worsening of these infections cannot be excluded, therefore it is advisable to avoid the use of Nurofen Fever and Pain in case of chickenpox. Caution is required (discuss with your doctor or pharmacist) before starting treatment in patients with a positive history of hypertension and\/or heart failure since fluid retention, hypertension and edema have been found in association with treatment with NSAIDs. Clinical studies and epidemiological data suggest that the use of ibuprofen, especially at high doses (2400 mg\/day) and for long-term treatments, may be associated with a modest increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke). In general, epidemiological studies do not suggest that low doses of ibuprofen (e.g. ≤ 1200 mg\/day) are associated with an increased risk of myocardial infarction. Patients with uncontrolled hypertension, congestive heart failure, established ischemic heart disease, peripheral arterial disease, and\/or cerebrovascular disease should be treated with ibuprofen only after careful consideration. Similar considerations must be made before starting long-term treatment in patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidemia, diabetes mellitus, smoking). The use of ibuprofen, acetylsalicylic acid or other analgesics, antipyretics, non-steroidal anti-inflammatories requires particular caution: • in case of current or previous asthma or allergic diseases: possible deterioration of bronchoconstriction; • in the presence of coagulation defects: reduction of coagulability; • in the presence of kidney disease, heart disease or hypertension: possible critical reduction in renal function (especially in subjects with impaired renal or hepatic function, heart failure or being treated with diuretics), nephrotoxicity or fluid retention; • in the presence of liver disease: possible hepatotoxicity; • rehydrate the subject before starting and during treatment in case of dehydration (for example due to fever, vomiting or diarrhea). The following precautions become relevant during prolonged treatments: • monitor for signs or symptoms of gastrointestinal ulceration or bleeding; • monitor for signs or symptoms of hepatotoxicity; • monitor for signs or symptoms of nephrotoxicity; • if visual disturbances occur (blurred or reduced vision, scotomas, alteration of color perception): stop treatment and consult your ophthalmologist; • if signs or symptoms of meningitis arise: evaluate the rare possibility that it is due to the use of ibuprofen (aseptic meningitis; more frequent in subjects suffering from systemic lupus erythematosus and mixed connective tissue disease or other collagenopathies) (see section 4.8). Since Nurofen Fever and Pain contains \u003cb\u003eliquid maltitol\u003c\/b\u003e, patients with rare hereditary problems of fructose intolerance should not take this medicine. May have a mild laxative effect. The caloric value of maltitol is 2.3 kcal\/g. Nurofen Fever and Pain does not contain sugar and is therefore indicated for those patients who need to control their intake of sugars and calories. This medicinal product contains less than 1 mmol (23 mg) of \u003cb\u003esodium\u003c\/b\u003e for doses up to 12 ml, i.e. essentially \"sodium-free\". This medicine contains approximately 27.6 mg of \u003cb\u003esodium\u003c\/b\u003e for each 15 ml dose, equivalent to approximately 1.4% of the maximum daily intake recommended by the WHO which corresponds to 2 g of sodium for an adult. NUROFEN FEVER AND PAIN 200 mg\/5ml oral suspension strawberry flavor without sugar contains approximately 16.45 mg of \u003cb\u003epropylene glycol\u003c\/b\u003e (present in the strawberry flavour) for 5 ml. NUROFEN FEVER AND PAIN 200 mg\/5ml sugar-free orange flavor oral suspension contains only a very small quantity of gluten (from\u003cb\u003ewheat starch\u003c\/b\u003e present in the orange flavour). This medicine is considered \"gluten-free\" and is very unlikely to cause problems for a celiac patient. A 5 ml dose contains no more than 0.315 micrograms of gluten. If the patient is allergic to wheat (condition other than celiac disease) he should not take this medicine.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eINTERACTIONS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cb\u003eIbuprofen should be avoided in association with\u003c\/b\u003e: • Acetylsalicylic acid (aspirin): unless low-dose acetylsalicylic acid (no more than 75 mg per day), as per common clinical practice, has been advised by your doctor, as it may increase the risk of adverse reactions (see section 4.4). Experimental data indicate that ibuprofen can inhibit the effects of low-dose acetylsalicylic acid on platelet aggregation when the drugs are administered concomitantly. However, the paucity of data and the uncertainties relating to the application of data extrapolated ex vivo to the clinical situation do not allow definitive conclusions to be drawn on the regular use of ibuprofen; Clinically relevant effects resulting from occasional use of ibuprofen are unlikely (see section 5.1). • \u003cb\u003eOther NSAIDs including selective cyclooxygenase-2 inhibitors\u003c\/b\u003e: avoid the simultaneous use of two or more analgesics, antipyretics, non-steroidal anti-inflammatory drugs: increased risk of side effects (see section 4.4). \u003cb\u003eIbuprofen should be used with caution in combination with:\u003c\/b\u003e • corticosteroids: increased risk of gastrointestinal ulceration or haemorrhage (see section 4.4); • quinolone antibiotics: data from animal studies indicate that NSAIDs may increase the risk of seizures associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may have an increased risk of developing seizures; • anticoagulants, such as warfarin: NSAIDs can increase the effects of anticoagulants (see section 4.4); • antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding (see section 4.4); • antidiabetics: possible increase in the effect of sulphonylureas; • antivirals, such as ritonavir: possible increase in the concentration of NSAIDs; • ciclosporin: increased risk of nephrotoxicity; • mifepristone: NSAIDs must not be administered in the 8-12 days following taking mifepristone as they can reduce its effectiveness; • cytotoxics, such as methotrexate: reduction of excretion (increased risk of toxicity); • lithium: reduction of excretion (increased risk of toxicity); • tacrolimus: increased risk of nephrotoxicity; • uricosurics, such as probenecid: slows down the excretion of NSAIDs (increase in plasma concentrations); • methotrexate: potential increase in plasma concentrations of methotrexate; • zidovudine: increased risk of blood toxicity when NSAIDs are used in combination with zidovudine. There are demonstrations of increased risk of haemarthrosis and hematomas in HIV (+) haemophiliacs if treated simultaneously with zidovudine and ibuprofen; • diuretics, ACE inhibitors and angiotensin II antagonists: NSAIDs can reduce the effect of diuretics and other antihypertensive drugs. In some patients with compromised renal function (e.g. dehydrated patients or elderly patients with compromised renal function) co-administration of an ACE inhibitor or an angiotensin II antagonist and agents that inhibit the cyclo-oxygenase system may lead to further deterioration of renal function, including possible acute renal failure, which is usually reversible. These interactions should be considered in patients taking Nurofen Fever and Pain concomitantly with ACE inhibitors or angiotensin II antagonists. Therefore, the combination should be administered with caution, especially in elderly patients. Patients should be adequately hydrated and monitoring of renal function should be considered after initiation of concomitant therapy and periodically; • Cardiac glycosides: NSAIDs can worsen heart failure, reduce GFR (glomerular filtration rate) and increase plasma levels of glycosides.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eSIDE EFFECTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eThe list of the following side effects includes all those that have been recognized during treatment with ibuprofen for short periods of treatment and for daily doses up to a maximum of 1200 mg. In the case of high-dose therapies for chronic or prolonged pathologies, other undesirable effects may occur. Adverse reactions associated with the administration of ibuprofen are listed below according to system organ class and frequency. Frequencies are defined as\u003ci\u003e:\u003c\/i\u003e Very common (≥1\/10); Common (≥1\/100, \u003c1\/10); Uncommon (≥1\/1,000, \u003c1\/100); Rare (≥1\/10,000, \u003c1\/1,000); Very rare (\u003c1\/10,000); Not known (frequency cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.\u003c\/p\u003e\n\u003cp\u003eInfections and infestations - Frequency: Rare. Adverse reaction: Cystitis, rhinitis.\u003c\/p\u003e\n\u003cp\u003eInfections and infestations - Frequency: Very rare. Adverse reaction: Worsening of infection-related inflammation (e.g. development of necrotizing fasciitis), in exceptional cases severe skin infections and soft tissue complications have been reported during a chickenpox infection.\u003c\/p\u003e\n\u003cp\u003eBlood and lymphatic system disorders - Frequency: Very rare. Adverse reaction: Hematopoiesis disorders ¹\u003c\/p\u003e\n\u003cp\u003eImmune system disorders - Frequency: Uncommon. Adverse reaction: Hypersensitivity reactions manifested by urticaria and pruritus²\u003c\/p\u003e\n\u003cp\u003eImmune system disorders - Frequency: Very rare. Adverse reaction: Severe hypersensitivity reactions including swelling of the face, tongue and larynx, dyspnoea, tachycardia, hypotension (anaphylaxis, angioedema or severe shock).\u003c\/p\u003e\n\u003cp\u003eMetabolism and nutrition disorders - Frequency: Not known. Adverse reaction: Fluid retention and decreased appetite³.\u003c\/p\u003e\n\u003cp\u003ePsychiatric disorders - Frequency: Not known. Adverse reaction: Irritability\u003c\/p\u003e\n\u003cp\u003ePsychiatric disorders - Frequency: Rare. Adverse reaction: Depression, insomnia, difficulty concentrating, emotional lability, visual and auditory disturbances.\u003c\/p\u003e\n\u003cp\u003eNervous system disorders - Frequency: Uncommon. Adverse reaction: Headache, dizziness, drowsiness, convulsions.\u003c\/p\u003e\n\u003cp\u003eNervous system disorders - Frequency: Very rare. Adverse reaction: Aseptic meningitis4.\u003c\/p\u003e\n\u003cp\u003eNervous system disorders - Frequency: Rare. Adverse reaction: Cerebrovascular haemorrhage.\u003c\/p\u003e\n\u003cp\u003eEye disorders - Frequency: Rare. Adverse reaction: Dry eyes.\u003c\/p\u003e\n\u003cp\u003eEar and labyrinth disorders - Frequency: Not known. Adverse reaction: Tinnitus.\u003c\/p\u003e\n\u003cp\u003eCardiac disorders - Frequency: Not known. Adverse reaction: Heart failure and edema5.\u003c\/p\u003e\n\u003cp\u003eCardiac disorders - Frequency: Rare. Adverse reaction: Palpitations.\u003c\/p\u003e\n\u003cp\u003eVascular disorders - Frequency: Not known. Adverse reaction: Hypertension5 and shock.\u003c\/p\u003e\n\u003cp\u003eRespiratory, thoracic and mediastinal disorders - Frequency: Not known. Adverse reaction: Respiratory tract reactivity including asthma, laryngeal obstruction, bronchospasm or apnea, dyspnea.\u003c\/p\u003e\n\u003cp\u003eGastrointestinal disorders - Frequency: Uncommon. Adverse reaction: Abdominal pain, nausea and dyspepsia6.\u003c\/p\u003e\n\u003cp\u003eGastrointestinal disorders - Frequency: Rare. Adverse reaction: Diarrhoea, flatulence, dry mouth, constipation and vomiting.\u003c\/p\u003e\n\u003cp\u003eGastrointestinal disorders - Frequency: Very rare. Adverse reaction: Peptic ulcer, gastrointestinal perforation or bleeding, melena and haematemesis7. Mouth ulcerations and gastritis.\u003c\/p\u003e\n\u003cp\u003eGastrointestinal disorders - Frequency: Not known. Adverse reaction: Exacerbation of colitis and Crohn's disease8, pancreatitis, duodenitis, esophagitis.\u003c\/p\u003e\n\u003cp\u003eHepatobiliary disorders - Frequency: Very rare. Adverse reaction: Liver dysfunction, hepatitis, jaundice, hepatorenal syndrome, hepatic necrosis, hepatic failure.\u003c\/p\u003e\n\u003cp\u003eSkin and subcutaneous tissue disorders - Frequency: Uncommon. Adverse reaction: Various skin rashes²\u003c\/p\u003e\n\u003cp\u003eSkin and subcutaneous tissue disorders - Frequency: Very rare. Adverse reaction: Bullous reactions including Stevens-Johnson syndrome, erythema multiforme and toxic epidermal necrolysis².\u003c\/p\u003e\n\u003cp\u003eSkin and subcutaneous tissue disorders - Frequency: Rare. Adverse reaction: Exfoliative dermatitis, alopecia, photosensitivity reactions.\u003c\/p\u003e\n\u003cp\u003eSkin and subcutaneous tissue disorders - Frequency: Not known. Adverse reaction: Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), acute generalized exanthematous pustulosis (PEAG).\u003c\/p\u003e\n\u003cp\u003eRenal and urinary disorders - Frequency: Rare. Adverse reaction: Tubular necrosis, glomerular nephritis, polyuria, hematuria.\u003c\/p\u003e\n\u003cp\u003eRenal and urinary disorders - Frequency: Very rare. Adverse reaction: Acute renal failure9.\u003c\/p\u003e\n\u003cp\u003eDiagnostic tests - Frequency: Rare. Adverse reaction: Decreased hematocrit levels.\u003c\/p\u003e\n\u003cp\u003eDiagnostic tests - Frequency: Very rare. Adverse reaction: Decreased hemoglobin levels.\u003c\/p\u003e\n\u003cp\u003e\u003cb\u003eDescription of some adverse reactions\u003c\/b\u003e \u003csup\u003e1\u003c\/sup\u003e Hematopoiesis disorders including anemia, aplastic anemia, hemolytic anemia (positive Coombs test), leukopenia, neutropenia, thrombocytopenia (with or without purpura), eosinophilia, pancytopenia, and agranulocytosis. The first symptoms may be: fever, sore throat, superficial mouth ulcers, flu-like symptoms, marked fatigue, nosebleeds and bleeding. Rarely congestive heart failure in patients with impaired cardiac function. ² Hypersensitivity reactions: these reactions include a) non-specific allergic reactions and anaphylaxis, fever, chills, b) respiratory tract reactivity including asthma, aggravated asthma, bronchospasm (see section 4.3 and 4.4) or dyspnoea or c) various skin conditions including various skin rashes (including maculopapular in nature), pruritus, urticaria with or without angioedema, purpura, angioedema and much rarely, bullous and exfoliative dermatitis including toxic epidermal necrolysis, Stevens-Johnson syndrome and erythema multiforme. ³ Decreased appetite: generally resolves rapidly upon discontinuation of treatment (see section 4.4). \u003csup\u003e4.\u003c\/sup\u003e The pathogenetic mechanism of drug-induced aseptic meningitis is not completely known. However, the data available on aseptic meningitis related to the administration of NSAIDs leads us to think of an immune reaction (due to a temporal relationship with the intake of the medicine and the disappearance of symptoms after discontinuation of treatment). Of note, individual cases of symptoms of aseptic meningitis (such as stiff neck, neck numbness, headache, nausea, vomiting, fever and disorientation) have been observed during treatment with ibuprofen in patients with autoimmune diseases (such as systemic lupus erythromatosus, mixed connective tissue disease). \u003csup\u003e5\u003c\/sup\u003e Heart failure and edema: Clinical studies and epidemiological data suggest that the use of ibuprofen, especially at high doses (2400 mg\/day) and for long-term treatments, may be associated with a modest increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke) (see section 4.4). Congestive heart failure in patients with impaired cardiac function. \u003csup\u003e6\u003c\/sup\u003e The most commonly observed adverse events are gastrointestinal in nature. Gastric discomfort can be reduced by taking the medicine on a full stomach. \u003csup\u003e7\u003c\/sup\u003e Peptic ulcers, gastrointestinal perforation or hemorrhage, melena, and sometimes fatal hematemesis may occur. \u003csup\u003e8\u003c\/sup\u003e Exacerbation of colitis and Crohn's disease (see section 4.4). \u003csup\u003e9\u003c\/sup\u003e Acute renal failure especially in case of long-term therapy, associated with increased serum urea levels and edema. Papillary necrosis may occur. \u003cb\u003eReporting of suspected adverse reactions\u003c\/b\u003e Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit\/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at: https:\/\/www.aifa.gov.it\/content\/segnalazioni-reazioni-avverse.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eOVERDOSE\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cu\u003eToxicity \u003c\/u\u003e Signs and symptoms of toxicity were generally not observed at doses below 100 mg\/kg in children or adults. However, in some cases supportive treatment may be necessary. Children have been observed to exhibit signs and symptoms of toxicity after ingesting ibuprofen at doses of 400 mg\/kg or greater. The half-life of the drug in case of overdose is 1.5-3 hours. \u003cu\u003eSymptoms \u003c\/u\u003e Most patients who accidentally ingest clinically relevant quantities of ibuprofen will experience symptoms within 4 to 6 hours. The most commonly reported overdose symptoms include: nausea, vomiting, abdominal pain, lethargy, and drowsiness. Central nervous system (CNS) effects include headache, tinnitus, dizziness, seizures, and loss of consciousness. Nystagmus, metabolic acidosis, hypothermia, renal effects, gastrointestinal bleeding, coma, apnea, diarrhea and CNS and respiratory depression have also been reported rarely. Disorientation, arousal, fainting and cardiovascular toxicity including hypotension, bradycardia and tachycardia have been reported. In cases of significant overdose, renal failure and liver damage are possible. In cases of severe poisoning, metabolic acidosis and a prolongation of the prothrombin time (INR) may occur, probably caused by interference with the action of coagulation factors present in the circulation. In asthmatic subjects, an exacerbation of the symptoms of the disease may occur. \u003cu\u003eTreatment \u003c\/u\u003e There is no specific antidote for ibuprofen overdose. In case of overdose, symptomatic and supportive treatment is therefore indicated and must include maintaining a patent airway and monitoring cardiac function and vital signs until the patient is stabilised. Particular attention is due to the control of blood pressure, acid-base balance and any gastrointestinal bleeding. Administration of activated charcoal should be considered within one hour of ingesting a potentially toxic quantity. Alternatively, in adults, gastric lavage should be considered within one hour of ingestion of a potentially life-threatening overdose. Adequate diuresis must be ensured and renal and hepatic functions must be closely monitored. The patient must remain under observation for at least four hours following ingestion of a potentially toxic amount of drug. Any occurrence of frequent or prolonged convulsions should be treated with intravenous diazepam or lorazepam. If ibuprofen has already been absorbed, alkaline substances should be administered to promote excretion of the acidic ibuprofen in the urine. Administer bronchodilators in case of asthma. Depending on the patient's clinical condition, other support measures may be necessary. For more information, contact your local poison control center.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003ePREGNANCY AND BREASTFEEDING\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eChildren under the age of 12 are unlikely to become pregnant or breastfeed. Furthermore, in such circumstances the following considerations must be kept in mind. \u003cu\u003ePregnancy \u003c\/u\u003e During the first and second trimesters of pregnancy, administration of ibuprofen should be avoided. Ibuprofen is contraindicated during the third trimester of pregnancy. Inhibition of prostaglandin synthesis can negatively affect pregnancy and\/or embryo\/foetal development. Results of epidemiological studies suggest an increased risk of miscarriage and cardiac malformation and gastroschisis after the use of a prostaglandin synthesis inhibitor in the early stages of pregnancy. The absolute risk of cardiac malformations increased from less than 1% to approximately 1.5%. The risk was thought to increase with the dose and duration of therapy. In animals, the administration of prostaglandin synthesis inhibitors has been shown to cause an increase in pre- and post-implantation loss and embryo-foetal mortality. Furthermore, an increased incidence of various malformations, including cardiovascular malformations, has been reported in animals administered prostaglandin synthesis inhibitors during the organogenetic period. During the third trimester of pregnancy, all inhibitors of prostaglandin synthesis can expose the fetus to: - cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension); - renal dysfunction which may progress to renal failure with oligo-hydramnios; the mother and the newborn, at the end of pregnancy, to: - possible prolongation of bleeding time, an anti-aggregating effect which can occur even at very low doses; - inhibition of uterine contractions resulting in delayed or prolonged labor. \u003cu\u003eBreastfeeding \u003c\/u\u003e There is limited data showing that ibuprofen can pass in low concentrations into breast milk and is unlikely to have any adverse effects on newborns.\u003cu\u003eFertility \u003c\/u\u003e There is evidence that medicinal products that inhibit the synthesis of cyclooxygenase\/prostaglandins can cause a weakening of female fertility by affecting ovulation. This effect is reversible after discontinuation of treatment. The administration of Nurofen should be suspended in women who have fertility problems or who are undergoing fertility investigations.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eEFFECTS ON DRIVING ABILITY\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eFor short periods of treatment, Nurofen Fever and Pain does not or negligibly alter the ability to drive and use machinery.\u003c\/p\u003e","brand":"Reckitt Benckiser","offers":[{"title":"Default Title","offer_id":51131258044743,"sku":"034102424","price":16.91,"currency_code":"EUR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0564\/4989\/2467\/files\/reckitt-benckiser-h-it-spa-nurofen-febbre-e-dolore-200mg-5ml-sospensione-orale-gusto-arancia-100ml-farmacia-dottor-tili-1213792296.jpg?v=1767143868"},{"product_id":"nurofen-400mg-12-compresse-rivestite","title":"Nurofen 400mg 12 coated tablets","description":"\u003cp\u003e\u003cstrong\u003eINDICATIONS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003ePain of various kinds: headache, toothache, neuralgia, muscular and osteoarticular pain, menstrual pain. Adjuvant in the symptomatic treatment of feverish and flu states. Nurofen is indicated in adults and adolescents over 12 years of age\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eACTIVE INGREDIENTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e200 mg coated tablets: each tablet contains 200 mg of ibuprofen 400 mg coated tablets: each tablet contains 400 mg of ibuprofen Excipients with known effects: Each 200 mg coated tablet contains: - 116.1 mg of sucrose, equivalent to approximately 0.34 mmol - 17.34 mg of sodium, equivalent to approximately 0.75 mmol Each 400 mg coated tablet contains: - 232.2 mg, equivalent to approximately 0.68 mmol - 34.69 mg sodium, equivalent to approximately 1.51 mmol. For the full list of excipients, see section 6.1.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eEXCIPIENTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cb\u003eNurofen 200 mg coated tablets\u003c\/b\u003e Croscarmellose sodium, \u003cb\u003esodium\u003c\/b\u003e lauryl sulfate, \u003cb\u003esodium\u003c\/b\u003e citrate, stearic acid, colloidal anhydrous silica, carmellose \u003cb\u003esodium\u003c\/b\u003e, talc, dried atomized gum arabic, \u003cb\u003esucrose\u003c\/b\u003e, titanium dioxide, macrogol 6000, ink (shellac, black iron oxide E172, propylene glycol E1520). \u003cb\u003eNurofen 400 mg coated tablets\u003c\/b\u003e Croscarmellose \u003cb\u003esodium\u003c\/b\u003e, \u003cb\u003esodium\u003c\/b\u003e lauryl sulfate, \u003cb\u003esodium\u003c\/b\u003e citrate, stearic acid, colloidal anhydrous silica, carmellose \u003cb\u003esodium\u003c\/b\u003e, talc, dried atomized gum arabic, \u003cb\u003esucrose\u003c\/b\u003e, titanium dioxide, macrogol 6000, ink (shellac, red iron oxide (E 172), propylene glycol (E1520), ammonium hydroxide (E527), simethicone).\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eCONTRAINDICATIONS AND SIDE EFFECTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eHypersensitivity to the active substance or to any of the excipients, listed in paragraph 6.1. Patients who have previously experienced hypersensitivity reactions (e.g. bronchospasm, asthma, rhinitis, angioedema or urticaria) following the use of ibuprofen, acetylsalicylic acid, or other non-steroidal anti-inflammatory products (NSAIDs). Patients with severe hepatic or renal impairment (see section 4.4). Severe heart failure (NYHA class IV) Patients with a history of gastrointestinal bleeding or perforation, related to previous NSAID therapy. Patients with current or previous recurrent peptic ulcers\/haemorrhages (two or more distinct episodes of proven ulceration or bleeding). During the last trimester of pregnancy (see section 4.6). Children under 12 years old. Before or after cardiac surgery.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eDOSAGE\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cu\u003eDosage \u003c\/u\u003e Only for a short period of treatment. Undesirable effects can be minimized by using the lowest effective dose for the shortest possible treatment duration needed to control symptoms (see section 4.4). If symptoms persist or worsen after a short period of treatment, consult your doctor. If the use of the medicine is necessary for more than 3 days in adolescents, or in the case of worsening of symptoms, the doctor should be consulted. \u003cb\u003e \u003cu\u003eNUROFEN 200 mg coated tablets\u003c\/u\u003e \u003c\/b\u003e \u003cb\u003e Pediatric population:\u003c\/b\u003e Do not administer to children under 12 years of age.\u003cb\u003eAdults and adolescents over 12 years old\u003c\/b\u003e: 1-2 tablets, 2-3 times a day. The interval between doses should not be less than 4 hours. Do not exceed a dose of 1200 mg (6 tablets) in 24 hours. \u003cb\u003eElderly\u003c\/b\u003e: No changes to the dosage schedule are required. \u003cb\u003e \u003cu\u003eNUROFEN 400 mg coated tablets\u003c\/u\u003e \u003c\/b\u003e \u003cb\u003ePediatric population:\u003c\/b\u003e Do not administer to children under 12 years of age.\u003cb\u003eAdults and adolescents over 12 years old\u003c\/b\u003e One tablet 2-3 times a day. The interval between doses should not be less than 4 hours. Do not exceed a dose of 1200 mg (3 tablets) in 24 hours. \u003cb\u003eElderly:\u003c\/b\u003e No changes to the dosage schedule are required. \u003cu\u003eMethod of administration \u003c\/u\u003e Oral use Patients with gastric sensitivity problems are advised to take Nurofen on a full stomach.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eCONSERVATION\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eNurofen 400 mg coated tablets: store at a temperature not exceeding 30°C.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eWARNINGS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eCaution is required in patients with coagulation defects. Side effects can be minimized by using the lowest effective dose for the shortest possible treatment duration needed to control symptoms (see gastrointestinal and cardiovascular risks below). \u003cb\u003eElderly\u003c\/b\u003e: Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which may be fatal (see section 4.2). \u003cb\u003ePediatric population\u003c\/b\u003e: in dehydrated adolescents there is a risk of impaired renal function. \u003cb\u003eRespiratory disorders\u003c\/b\u003e: bronchospasm may occur in patients with bronchial asthma or current or previous allergic diseases. \u003cb\u003eOther NSAIDs\u003c\/b\u003e: The use of Nurofen should be avoided concomitantly with other NSAIDs, including selective cyclooxygenase-2 inhibitors. (see paragraph 4.5) \u003cb\u003eSLE and mixed connective tissue disease\u003c\/b\u003e Systemic lupus erythematosus and with mixed connective tissue disease due to increased risk of aseptic meningitis (see section 4.8); \u003cb\u003eCardiovascular and cerebrovascular effects\u003c\/b\u003e: caution is required (discuss with your doctor or pharmacist) before starting treatment in patients with a positive history of hypertension and\/or heart failure since fluid retention, hypertension and edema have been reported in association with treatment with NSAIDs. Clinical studies suggest that the use of ibuprofen, especially at high doses (2400 mg\/day), may be associated with a modest increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke). In general, epidemiological studies do not suggest that low doses of ibuprofen (e.g. ≤ 1200 mg\/day) are associated with an increased risk of arterial thrombotic events. Patients with uncontrolled hypertension, congestive heart failure (NYHA class II-III), established ischemic heart disease, peripheral arterial disease and\/or cerebrovascular disease should be treated with ibuprofen only after careful consideration and high doses (2400 mg\/day) should be avoided. Careful consideration must also be exercised before starting long-term treatment for patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidemia, diabetes mellitus, cigarette smoking habit), especially if high doses (2400 mg\/day) of ibuprofen are necessary. \u003cb\u003eLiver or kidney function:\u003c\/b\u003e • renal failure, as renal function may be compromised (see sections 4.3 and 4.8). In general, the habitual use of analgesics, especially combinations of different analgesic active ingredients, can lead to permanent kidney damage with the risk of the onset of renal failure (analgesic nephropathy). • liver dysfunction (see sections 4.3 and 4.8). Particular caution should be taken when treating patients with reduced hepatic or renal function. In such patients it is advisable to resort to periodic monitoring of clinical and laboratory parameters, especially in case of prolonged treatment. \u003cb\u003eCompromised female fertility\u003c\/b\u003e: Administration of Nurofen should be avoided in women planning pregnancy (see section 4.6). \u003cb\u003eGastrointestinal safety\u003c\/b\u003e: NSAIDs should be administered with caution to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated (see section 4.8). Gastrointestinal haemorrhage, ulceration and perforation, which may be fatal, have been reported during treatment with all NSAIDs at any time, with or without warning symptoms or previous history of serious gastrointestinal events. In the elderly and in patients with a history of ulcer, especially if complicated by haemorrhage or perforation (see section 4.3), the risk of gastrointestinal haemorrhage, ulceration or perforation is higher with increased doses of NSAIDs. These patients should start treatment with the lowest available dose. The concomitant use of protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients and also for patients taking low doses of acetylsalicylic acid or other drugs that may increase the risk of gastrointestinal events (see section 4.5). Patients with a history of gastrointestinal toxicity, particularly the elderly, should report any unusual gastrointestinal symptoms (especially gastrointestinal haemorrhage) particularly in the initial stages of treatment. Caution should be exercised in patients taking concomitant medications that may increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or antiplatelet agents such as acetylsalicylic acid (see section 4.5). When gastrointestinal bleeding or ulceration occurs in patients taking Nurofen, treatment should be discontinued. \u003cb\u003eSevere skin reactions:\u003c\/b\u003e Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported rarely in association with the use of NSAIDs (see section 4.8). Patients appear to be at higher risk in the early stages of therapy: the onset of the reaction occurs in most cases within the first month of treatment. Acute generalized exanthematous pustulosis (PEAG) has been reported in connection with ibuprofen-containing medicinal products. Ibuprofen should be discontinued at the first appearance of signs and symptoms of severe skin reactions, such as rash, mucosal lesions or any other sign of hypersensitivity. \u003cb\u003eMasking of symptoms of underlying infections\u003c\/b\u003e: Nurofen may mask the symptoms of infection, which may delay the initiation of appropriate treatment and therefore worsen the outcome of the infection. This has been observed in community-acquired bacterial pneumonia and bacterial complications of chickenpox. When Nurofen is given for the relief of fever or pain related to infection, monitoring of the infection is advised. In non-hospital settings, the patient should seek medical attention if symptoms persist or worsen. \u003cb\u003eOther:\u003c\/b\u003e during prolonged treatments with analgesic medicinal products at doses higher than those indicated, headaches may occur which must not be treated with higher doses of the product. Alcohol consumption should be avoided as it can intensify the side effects of NSAIDs, especially those affecting the gastrointestinal tract or central nervous system. At the first signs of hypersensitivity reaction after administration of ibuprofen, treatment should be discontinued. Medically assisted measures must be initiated by specialized medical personnel, in line with the symptoms. Acid ibuprofen can cause a prolongation of the bleeding time by reversibly inhibiting the aggregation of platelets. \u003cb\u003eImportant information about some excipients\u003c\/b\u003e \u003cu\u003eNurofen\u003c\/u\u003e contains sucrose: patients suffering from rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase isomaltase insufficiency should not take this medicine. \u003cu\u003eNurofen 200 mg coated tablets\u003c\/u\u003e contains sodium: this medicine contains less than 1 mmol (23 mg) sodium per tablet (17.34 mg), i.e. essentially 'sodium-free' and just over 1 mmol (23 mg) sodium per 2 tablets (34.68 mg), equivalent to 1.73% of the maximum daily intake recommended by the WHO which corresponds to 2 g sodium for an adult. \u003cu\u003eNurofen 400 mg coated tablets contain sodium\u003c\/u\u003e: This medicine contains 34.69 mg sodium per tablet, equivalent to 1.73% of the WHO recommended maximum daily intake of 2 g sodium for an adult.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eINTERACTIONS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eIbuprofen should be avoided in association with: - Acetylsalicylic acid: concomitant administration of ibuprofen and acetylsalicylic acid is generally not recommended due to the potential for increased side effects (see section 4.4). Experimental data suggest that ibuprofen can competitively inhibit the effect of low-dose acetylsalicylic acid on platelet aggregation when the two drugs are administered simultaneously. Although there are uncertainties regarding the extrapolation of these data to the clinical situation, the possibility cannot be excluded that regular, long-term use of ibuprofen may reduce the cardioprotective effect of acetylsalicylic acid at low doses. No relevant clinical effects are considered likely following occasional use of ibuprofen (see section 5.1). - Other NSAIDs including selective cyclooxygenase-2 inhibitors: the concomitant use of two or more NSAIDs should be avoided as they may increase the risk of adverse reactions affecting the gastrointestinal tract (see section 4.4). Ibuprofen (like other NSAIDs) should be used with caution in association with: - Corticosteroids: increased risk of gastrointestinal ulceration or haemorrhage (see section 4.4) - Anticoagulants: NSAIDs may increase the effects of anticoagulants, such as warfarin (see section 4.4) - Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal haemorrhage (see section 4.4). - Antihypertensives (ACE inhibitors and Angiotensin II Antagonists), diuretics and beta blockers: NSAIDs can reduce the effect of diuretics and other antihypertensive drugs. In some patients with compromised renal function (e.g. dehydrated patients or elderly patients with compromised renal function) co-administration of an ACE inhibitor or an angiotensin II antagonist and agents that inhibit the cyclo-oxygenase system may lead to further deterioration of renal function, including possible acute renal failure, which is usually reversible. These interactions should be considered in patients taking a coxib (such as Nurofen) concomitantly with ACE inhibitors or angiotensin II antagonists. Therefore, the combination should be administered with caution, especially in elderly patients. Patients should be adequately hydrated and consideration should be given to monitoring renal function after initiation of concomitant therapy and at regular intervals thereafter. Diuretics may increase the risk of NSAID nephrotoxicity. - Cardiac glycosides: NSAIDs can worsen heart failure, reduce GFR (glomerular filtration rate) and increase plasma levels of glycosides. - Lithium. There are demonstrations of the possibility of a potential increase in lithium levels in the blood, with the possibility of reaching the toxic threshold. If this combination is necessary, monitor lithium levels in order to adapt the lithium dosage during simultaneous treatment with ibuprofen. - Methotrexate. There is evidence of the possibility of an increase in plasma levels of methotrexate. - Cyclosporins: increase the risk of nephrotoxicity. - Mifepristone: NSAIDs should not be taken for 8-12 days after administration of Mifepristone as NSAIDs may reduce the effects of Mifepristone. - Tacrolimus: possible increased risk of nephrotoxicity when NSAIDs are administered with Tacrolimus. - Zidovudine: increased risk of haematological toxicity when NSAIDs are administered with Zidovudine. There is evidence of an increased risk of haemarthrosis and haematoma in HIV-positive haemophilia patients if treated simultaneously with zidovudine and ibuprofen. - Antibiotics quinolones: Data from animal studies indicate that NSAIDs may increase the risk of seizures associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may have an increased risk of developing seizures. - Alcohol, bisphosphonates and pentoxifylline: can potentiate gastrointestinal side effects and the risk of bleeding and ulcers. - Baclofen: high toxicity of baclofen.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eSIDE EFFECTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eThe list of the following side effects includes side effects that have been observed during treatment with ibuprofen at self-medication doses (up to a maximum of 1200mg per day). In case of chronic conditions, additional side effects may occur during long-term treatment. The side effects associated with the administration of ibuprofen are listed below according to system organ classification and frequency. \u003ci\u003eFor the frequency of occurrence of side effects, the following expressions are used:\u003c\/i\u003e \u003ci\u003eVery common (\u003c\/i\u003e≥ \u003ci\u003e1\/10)\u003c\/i\u003e; \u003ci\u003eMunicipality (\u003c\/i\u003e≥ \u003ci\u003e1\/100, \u0026lt;1\/10)\u003c\/i\u003e; \u003ci\u003eUncommon (\u003c\/i\u003e≥ \u003ci\u003e1\/1000, \u0026lt;1\/100)\u003c\/i\u003e; \u003ci\u003eRare (\u003c\/i\u003e≥ \u003ci\u003e1\/10.000, \u0026lt;1\/1000)\u003c\/i\u003e; \u003ci\u003eVery rare (\u003c1\/10,000)\u003c\/i\u003e; \u003ci\u003eNot known (frequency cannot be estimated from the available data)\u003c\/i\u003e. \u003ci\u003eWithin each frequency grouping, undesirable effects are presented in order of decreasing seriousness.\u003c\/i\u003e\u003c\/p\u003e\n\u003cp\u003eBlood and lymphatic system disorders - Frequency: Very Rare. Adverse Reaction: Hematopoietic disorders¹\u003c\/p\u003e\n\u003cp\u003eImmune system disorders - Frequency: Uncommon. Adverse Reaction: Hypersensitivity reactions including urticaria and pruritus²\u003c\/p\u003e\n\u003cp\u003eImmune system disorders - Frequency: Very Rare. Adverse Reaction: Severe hypersensitivity reactions including swelling of the face, tongue and throat, dyspnoea, tachycardia, hypotension (anaphylaxis, angioedema or severe shock)²\u003c\/p\u003e\n\u003cp\u003eNervous system disorders - Frequency: Uncommon. Adverse Reaction: Headache, dizziness.\u003c\/p\u003e\n\u003cp\u003eNervous system disorders - Frequency: Rare. Adverse Reaction: Cerebrovascular accident9.\u003c\/p\u003e\n\u003cp\u003eNervous system disorders - Frequency: Very rare. Adverse Reaction: Aseptic meningitis³\u003c\/p\u003e\n\u003cp\u003eEye disorders - Frequency: Very Rare. Adverse Reaction: Visual disturbances.\u003c\/p\u003e\n\u003cp\u003eCardiac disorders - Frequency: Very rare. Adverse Reaction: Heart failure and edema4.\u003c\/p\u003e\n\u003cp\u003eVascular disorders - Frequency: Very rare. Adverse Reaction: Hypertension4.\u003c\/p\u003e\n\u003cp\u003eRespiratory, thoracic and mediastinal disorders - Frequency: Not known. Adverse Reaction: Respiratory tract reactivity including asthma, worsening of asthma, bronchospasm or dyspnea.\u003c\/p\u003e\n\u003cp\u003eGastrointestinal disorders - Frequency: Uncommon. Adverse Reaction: Dyspepsia, abdominal pain and nausea5.\u003c\/p\u003e\n\u003cp\u003eGastrointestinal disorders - Frequency: Rare. Adverse Reaction: Diarrhoea, flatulence, constipation and vomiting.\u003c\/p\u003e\n\u003cp\u003eGastrointestinal disorders - Frequency: Very rare. Adverse Reaction: Peptic ulcers, gastrointestinal perforation or hemorrhage, melena, hematemesis6, ulcerative stomatitis, gastritis.\u003c\/p\u003e\n\u003cp\u003eGastrointestinal disorders - Frequency: Not known. Adverse Reaction: Exacerbation of colitis and Crohn's disease7, pancreatitis.\u003c\/p\u003e\n\u003cp\u003eHepatobiliary disorders - Frequency: Rare. Adverse Reaction: Hepatotoxicity\u003c\/p\u003e\n\u003cp\u003eHepatobiliary disorders - Frequency: Very rare. Adverse Reaction: Liver disorders, especially following long-term treatment, hepatitis, jaundice.\u003c\/p\u003e\n\u003cp\u003eSkin and subcutaneous tissue disorders - Frequency: Uncommon. Adverse Reaction: Skin rashes².\u003c\/p\u003e\n\u003cp\u003eSkin and subcutaneous tissue disorders - Frequency: Very rare. Adverse Reaction: Erythema multiforme, bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis.²\u003c\/p\u003e\n\u003cp\u003eSkin and subcutaneous tissue disorders - Frequency: Not known. Adverse Reaction: Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), acute generalized exanthematous pustulosis (PEAG), photosensitivity reactions\u003c\/p\u003e\n\u003cp\u003eRenal and urinary disorders - Frequency: Very rare. Adverse Reaction: Acute renal failure8, hematuria, nephritis, nephrotic syndrome9.\u003c\/p\u003e\n\u003cp\u003eDiagnostic tests - Frequency: Rare. Adverse Reaction: Increased transaminases, increased alkaline phosphatase, decreased hematocrit, prolonged bleeding time, decreased blood calcium, increased uric acid.\u003c\/p\u003e\n\u003cp\u003eDiagnostic tests - Frequency: Very rare. Adverse Reaction: Decreased hemoglobin level in the blood.\u003c\/p\u003e\n\u003cp\u003e\u003cb\u003eDescription of some side effects\u003c\/b\u003e \u003csup\u003e1\u003c\/sup\u003e Examples include anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). The first manifestations are: fever, sore throat, superficial ulcers of the oral cavity, flu-like symptoms, severe fatigue, bruises and unexplained bleeding. ² Hypersensitivity reactions: these reactions may include a) non-specific allergic reactions and anaphylaxis, b) respiratory tract reactivity including asthma, worsening of asthma, bronchospasm or dyspnoea or c) various skin conditions such as various skin rashes, pruritus, urticaria, purpura, angioedema and very rarely bullous and exfoliative dermatitis including toxic epidermal necrolysis, Stevens-Johnson syndrome and erythema multiforme. ³ The pathogenesis of drug-induced aseptic meningitis is not completely understood. However, the data available on aseptic meningitis related to the administration of NSAIDs leads us to think of an immune hypersensitivity reaction (due to a temporary relationship with the intake of the medicine and the disappearance of symptoms after discontinuation of treatment). Of note, individual cases of aseptic meningitis symptoms (such as stiff neck, headache, nausea, vomiting, fever and disorientation) have been observed during treatment with ibuprofen in patients with autoimmune disorders (such as systemic lupus erythematosus, mixed connective tissue disease). \u003csup\u003e4\u003c\/sup\u003e Clinical studies suggest that the use of ibuprofen, especially at high doses (2400 mg\/day) may be associated with a modest increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke) (see section 4.4) \u003csup\u003e5\u003c\/sup\u003e The most commonly observed adverse reactions are gastrointestinal in nature. \u003csup\u003e6\u003c\/sup\u003e sometimes fatal, particularly in the elderly \u003csup\u003e7\u003c\/sup\u003e see paragraph 4.4 \u003csup\u003e8\u003c\/sup\u003e particularly following long-term treatment, associated with increased serum urea concentrations. Decreased urea excretion and edema. Also includes papillary necrosis \u003csup\u003e9\u003c\/sup\u003e reported as an effect of NSAID class \u003cb\u003eReporting of suspected adverse reactions\u003c\/b\u003e Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit\/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at: https:\/\/www.aifa.gov.it\/content\/segnalazioni-reazioniavverse.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eOVERDOSE\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cu\u003eToxicity \u003c\/u\u003e Signs and symptoms of toxicity were generally not observed at doses below 100 mg\/kg in children or adults. However, in some cases supportive treatment may be necessary. Children have been observed to exhibit signs and symptoms of toxicity after ingesting ibuprofen at doses of 400 mg\/kg or greater. \u003cu\u003eSymptoms \u003c\/u\u003e Most patients who have ingested significant amounts of ibuprofen will experience symptoms within 4 to 6 hours. The most commonly reported overdose symptoms include: nausea, vomiting, abdominal pain, lethargy, and drowsiness. Central nervous system (CNS) effects include headache, tinnitus, dizziness, seizures, and loss of consciousness. Nystagmus, metabolic acidosis, hypothermia, renal effects, gastrointestinal bleeding, coma, apnea, diarrhea and depression of the CNS and respiratory system, blurring of vision have also been reported rarely. Disorientation, arousal, fainting and cardiovascular toxicity including hypotension, bradycardia and tachycardia have been reported. In cases of significant overdose, renal failure and liver damage are possible. In cases of severe poisoning, metabolic acidosis and a prolongation of the prothrombin time\/INR may occur, probably caused by interference with the action of coagulation factors present in the circulation. In asthmatic subjects, asthma exacerbation may occur. \u003cu\u003eTreatment \u003c\/u\u003e There is no specific antidote for ibuprofen overdose. In case of overdose, symptomatic and supportive treatment is therefore indicated and must include maintaining a patent airway and monitoring cardiac function and vital signs until the patient is stabilised. Particular attention is due to the control of blood pressure, acid-base balance and any gastrointestinal bleeding. Administration of activated charcoal should be considered within one hour of ingesting a potentially toxic quantity. Alternatively, in adults, gastric lavage should be considered within one hour of ingestion of a potentially life-threatening overdose. Adequate diuresis must be ensured and renal and hepatic functions must be closely monitored. The patient must remain under observation for at least four hours following ingestion of a potentially toxic amount of drug. Any occurrence of frequent or prolonged convulsions should be treated with intravenous diazepam. If ibuprofen has already been absorbed, alkaline substances should be administered to promote excretion of the acidic ibuprofen in the urine. Administer bronchodilators in case of asthma. Depending on the patient's clinical condition, other support measures may be necessary. For more information, contact your local poison control center.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003ePREGNANCY AND BREASTFEEDING\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cu\u003ePregnancy\u003c\/u\u003e Inhibition of prostaglandin synthesis can negatively affect the pregnant woman and\/or embryo\/foetal development. Data obtained from epidemiological studies suggest an increased risk of miscarriage, cardiac malformation and gastroschisis after the use of a prostaglandin synthesis inhibitor during early pregnancy. The absolute risk of cardiac malformations increased from less than 1% to approximately 1.5%. The risk is thought to increase with the dose and duration of therapy. In animals, the administration of prostaglandin synthesis inhibitors has been shown to cause an increase in pre- and post-implantation loss and embryo-foetal mortality. Furthermore, an increased incidence of various malformations, including cardiovascular malformations, has been reported in animals to which prostaglandin synthesis inhibitors were administered during the organogenetic period. From the 20th\u003csup\u003ea\u003c\/sup\u003e week of pregnancy onwards, the use of ibuprofen could cause oligohydramnios resulting from fetal renal dysfunction. This condition may be experienced shortly after starting treatment and is usually reversible upon discontinuation of treatment. Additionally, cases of constriction of the ductus arteriosus have been reported following treatment in the second trimester, most of which resolved after treatment was discontinued. Therefore, during the first and second trimester of pregnancy ibuprofen should not be administered unless strictly necessary. If ibuprofen is used by a woman planning pregnancy, or during the first and second trimester of pregnancy, the lowest possible dose should be used for the shortest possible time. Following exposure to ibuprofen for several days from the 20th\u003csup\u003ea\u003c\/sup\u003e week of gestation onwards, antenatal monitoring for oligohydramnios and ductus arteriosus constriction should be considered. In case of oligohydramnios or constriction of the ductus arteriosus, treatment with ibuprofen should be discontinued. During the third trimester of pregnancy, all inhibitors of prostaglandin synthesis can expose the fetus to: - cardiopulmonary toxicity (premature constriction\/closure of the ductus arteriosus and pulmonary hypertension); - renal dysfunction (see above); the mother and the newborn, at the end of pregnancy, to: - possible prolongation of bleeding time, an anti-aggregating effect which can occur even at very low doses; - inhibition of uterine contractions resulting in delayed or prolonged labor. Consequently, Nurofen is contraindicated during the third trimester of pregnancy (see sections 4.3 and 5.3). \u003cu\u003eBreastfeeding \u003c\/u\u003e Ibuprofen and its metabolites can pass in low concentrations into breast milk. No dangerous effects for newborns are known to date, therefore for short treatments with the recommended dose for pain and fever, interruption of breastfeeding is generally not necessary. \u003cu\u003eFertility \u003c\/u\u003e There is evidence that medicinal products that inhibit the synthesis of cyclooxygenase\/prostaglandins can cause a weakening of female fertility by affecting ovulation. This effect is reversible after discontinuation of treatment. The administration of Nurofen should be suspended in women who have fertility problems or who are undergoing fertility investigations.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eEFFECTS ON DRIVING ABILITY\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eFor short periods of treatment, Nurofen has no or negligible influence on the ability to drive and use machinery.\u003c\/p\u003e","brand":"Reckitt Benckiser","offers":[{"title":"Default Title","offer_id":51131274527047,"sku":"025634128","price":10.51,"currency_code":"EUR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0564\/4989\/2467\/files\/reckitt-benckiser-h-it-spa-nurofen-400mg-12-compresse-rivestite-farmacia-dottor-tili-1213792250.jpg?v=1767133411"},{"product_id":"nurofencaps-400mg-10-capsule-molli","title":"Nurofencaps 400mg 10 soft capsules","description":"\u003cp\u003e\u003cstrong\u003eINDICATIONS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eThis medicine is indicated in adults, children and adolescents weighing more than 40 kg (from 12 years of age) for the short-term symptomatic treatment of mild to moderate pain, such as headache, menstrual pain, toothache and pain associated with the common cold.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eACTIVE INGREDIENTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eEach capsule contains Ibuprofen 400 mg Excipients with known effects: Sorbitol (E420) 36.6 mg\/capsule; Ponceau 4R (E124) 0.79 mg\/capsule. For the full list of excipients see section 6.1.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eEXCIPIENTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cu\u003eFilling\u003c\/u\u003e: Macrogol 600, Potassium hydroxide, Purified water. \u003cu\u003eGelatin casing\u003c\/u\u003e: Jelly, \u003cb\u003eLiquid Sorbitol (E420)\u003c\/b\u003e, \u003cb\u003ePonceau 4R (E124)\u003c\/b\u003e. \u003cu\u003eInk\u003c\/u\u003e: Titanium dioxide (E171), Propylene glycol, Hypromellose (E464). \u003cu\u003eProcess aids\u003c\/u\u003e: Triglycerides (medium chain), Lecithin (E322).\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eCONTRAINDICATIONS AND SIDE EFFECTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e• Hypersensitivity to the active substance or to any of the excipients listed in paragraph 6.1. • Patients who have experienced hypersensitivity reactions (such as bronchospasm, asthma, rhinitis, angioedema or urticaria) associated with the use of acetylsalicylic acid (ASA) or other non-steroidal anti-inflammatory products (NSAIDs). • History of gastrointestinal bleeding or perforation related to previous NSAID treatment • Patients with current peptic ulcer\/haemorrhage or history of recurrent peptic ulcer\/haemorrhage (two or more distinct episodes of proven ulceration or bleeding). • Patients with severe hepatic, renal or cardiac insufficiency (NYHA Class IV). See also section 4.4 • Patients with cerebrovascular bleeding or other active bleeding. • Patients with unclear hematopoiesis disorders. • Patients with severe dehydration (caused by vomiting, diarrhea or insufficient fluid intake) • During the last trimester of pregnancy (see section 4.6). • Adolescents weighing less than 40 kg or children under 12 years of age.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eDOSAGE\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cu\u003eDosage\u003c\/u\u003e Only for a short period of treatment. Undesirable effects can be minimized by using the lowest effective dose for the shortest possible treatment duration needed to control symptoms (see section 4.4). \u003cu\u003eAdults, children and adolescents weighing more than 40 kg (from 12 years of age)\u003c\/u\u003e. The initial dose is one capsule to be taken with water. Then, if necessary, one capsule every 6 hours. Do not exceed the dose of 3 capsules (1200 mg) in 24 hours. If the use of the medicine is necessary for more than 3 days in adolescents or in the case of worsening of symptoms, the doctor should be consulted. If in adults it is necessary to administer the product for more than 3 days in case of fever and 4 days for the treatment of pain, or if the symptoms worsen, consult your doctor. The onset of the effect of Nurofencaps may be delayed if the medicine is taken shortly after eating. If this occurs, do not take a higher dose of Nurofencaps than recommended in section 4.2 (dosage) or wait for the necessary time to elapse between one administration and another. \u003cb\u003eSpecial populations\u003c\/b\u003e \u003cu\u003eElderly\u003c\/u\u003e: No special dose adjustment is required. Due to the possible adverse effect profile (see section 4.4) elderly people should be monitored with particular attention. \u003cu\u003eRenal failure\u003c\/u\u003e No dose reduction is required in patients with mild to moderate renal impairment (for patients with severe renal impairment see section 4.3). \u003cu\u003eHepatic failure (see section 5.2)\u003c\/u\u003e No dose reduction is required in patients with mild to moderate hepatic impairment (for patients with severe hepatic impairment see section 4.3). \u003cu\u003eChildren and adolescents\u003c\/u\u003e For use in children and adolescents see section 4.3. \u003cu\u003eMethod of administration\u003c\/u\u003e For oral use. The capsules should not be chewed. It is recommended that patients with gastric sensitivity problems take Nurofencaps on a full stomach.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eCONSERVATION\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eDo not store above 25°C. Store in the original package to protect the medicine from moisture.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eWARNINGS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eSide effects can be minimized by using the lowest effective dose for the shortest possible treatment duration needed to control symptoms (see below for gastrointestinal and cardiovascular risks). Caution is required in patients with the following conditions, which may worsen: • systemic lupus erythematosus and mixed connective tissue disease - for increased risk of aseptic meningitis (see section 4.8) • congenital disorders of porphyrin metabolism (e.g. Acute Intermittent Porphyria) • gastrointestinal disorders and chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease (see section 4.8) • hypertension and\/or heart failure (see sections 4.3 and 4.8) • renal failure, as renal function may be impaired (see sections 4.3 and 4.8) • liver dysfunction (see sections 4.3 and 4.8) • immediately after major surgery • In patients who experience allergic reactions to other substances, as they are at higher risk of developing hypersensitivity reactions even when using Nurofencaps • In patients suffering from hay fever, nasal polyps, respiratory disorders chronic obstructive disorders, or who have a history of allergic diseases, as there is an increased risk for these patients of developing allergic reactions. These can manifest themselves in the form of asthma attacks (so-called \"analgesic asthma\"), Quincke's edema or urticaria. \u003cu\u003eMasking of symptoms of underlying infections\u003c\/u\u003e Nurofencaps may mask the symptoms of infection, which could delay the initiation of appropriate treatment and therefore worsen the outcome of the infection. This has been observed in community-acquired bacterial pneumonia and bacterial complications of chickenpox. When Nurofencaps is administered for the relief of fever or pain related to infection, monitoring of the infection is advised. In non-hospital settings, the patient should seek medical attention if symptoms persist or worsen. \u003cu\u003eGastrointestinal (GI) safety\u003c\/u\u003e: Concomitant use of other NSAIDs, including selective cyclooxygenase-2 inhibitors, increases the risk of adverse reactions (see section 4.5) and should be avoided. \u003cu\u003eElderly\u003c\/u\u003e: Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which may be fatal (see section 4.2). \u003cu\u003eGastrointestinal bleeding, ulceration and perforation\u003c\/u\u003e: Gastrointestinal haemorrhage, ulceration and perforation, which may be fatal, have been reported during treatment with all NSAIDs at any time, with or without warning symptoms or previous history of serious gastrointestinal events. When gastrointestinal bleeding or ulceration occurs following administration of ibuprofen, treatment should be discontinued. In the elderly and in patients with a history of ulcer, especially if complicated by haemorrhage or perforation (see section 4.3), the risk of gastrointestinal haemorrhage, ulceration or perforation is higher with increased doses of NSAIDs. These patients should start treatment with the lowest available dose. Concomitant use of protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients and also for patients taking low doses of acetylsalicylic acid or other drugs that may increase the risk of gastrointestinal events (see section 4.5). Patients with a history of gastrointestinal toxicity, particularly the elderly, should report any unusual gastrointestinal symptoms (especially gastrointestinal bleeding), particularly in the initial stages of treatment. Caution should be advised in patients taking concomitant medications that may increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors (SSRIs) or antiplatelet agents such as acetylsalicylic acid (see section 4.5). NSAIDs should be administered with caution to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated (see section 4.8). \u003cu\u003eSevere skin reactions\u003c\/u\u003e: Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported very rarely in association with the use of NSAIDs (see section 4.8). Patients appear to be at higher risk in the early stages of therapy: the onset of the reaction occurs in most cases within the first month of treatment. Acute generalized exanthematous pustulosis (PEAG) has been reported in connection with ibuprofen-containing medicinal products. Nurofencaps should be discontinued at the first appearance of signs and symptoms of severe skin reactions, such as rash, mucosal lesions or any other sign of hypersensitivity. Chickenpox can exceptionally cause serious infectious complications to the skin and soft tissues. It is advisable to avoid using Nurofencaps in case of chickenpox. \u003cu\u003eCardiovascular and cerebrovascular effects\u003c\/u\u003e: Before starting treatment in patients with a history of hypertension and\/or heart failure, caution is required (consult your doctor or pharmacist) since fluid retention, hypertension and edema have been reported in association with treatment with NSAIDs. Clinical studies suggest that the use of ibuprofen, especially at high doses (2400 mg per day), may be associated with a modest increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke). In general, epidemiological studies do not suggest that low doses of ibuprofen (e.g. ≤1200 mg per day) are associated with an increased risk of arterial thrombotic events. Patients with uncontrolled hypertension, congestive heart failure (NYHA class II-III), established ischemic heart disease, peripheral arterial disease and\/or cerebrovascular disease should be treated with ibuprofen only after careful consideration and high doses (2400 mg\/day) should be avoided. Careful consideration must also be exercised before starting patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidemia, diabetes mellitus, cigarette smoking habit) on long-term treatment, especially if high doses (2400 mg\/day) of ibuprofen are necessary. \u003cu\u003eOther considerations\u003c\/u\u003e Severe acute hypersensitivity reactions (e.g. anaphylactic shock) are observed very rarely. At the first signs of hypersensitivity reaction after administration\/taking of Nurofencaps, therapy should be discontinued. The medical aid measures required based on the symptoms must be undertaken by specialized personnel. Ibuprofen, the active ingredient in Nurofencaps, can temporarily inhibit the function of platelets (thrombocyte aggregation), therefore it is recommended to carefully monitor patients with coagulation disorders. In case of prolonged administration of Nurofencaps, regular monitoring of liver values, renal function and blood counts is required. Prolonged use of any type of pain reliever for headaches can worsen symptoms. If this situation occurs or is suspected, the doctor should be consulted and treatment should be suspended. The diagnosis of headache due to medication abuse (\u003ci\u003emedication overuse headache -MOH\u003c\/i\u003e) should be suspected in patients who experience frequent or daily headaches despite or because of regular use of headache medications. The habitual use of analgesics, especially combinations of different analgesic active ingredients, can lead to permanent kidney damage with the risk of onset of renal failure (analgesic nephropathy). This risk may be increased by salt loss and dehydration. Side effects related to the active ingredient, in particular those relating to the gastrointestinal tract or central nervous system, may be increased by taking NSAIDs in combination with alcohol. There is some evidence that medicinal products that inhibit cyclooxygenase\/prostaglandin synthesis may cause impairment of female fertility through effect on ovulation. This effect is reversible after discontinuation of treatment. (see section 4.6). In dehydrated children and adolescents there is a risk of impaired kidney function. This medicine contains \u003cb\u003esorbitol\u003c\/b\u003e: Patients suffering from rare hereditary problems of fructose intolerance should not take this medicine. This medicine contains \u003cb\u003ePonceau 4R (E124)\u003c\/b\u003e. May cause allergic reactions.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eINTERACTIONS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cu\u003eAcetylsalicylic acid (low dose)\u003c\/u\u003e. Concomitant administration of ibuprofen and acetylsalicylic acid is generally not recommended due to the potential for increased side effects. Experimental data suggest that ibuprofen can competitively inhibit the effects of low-dose acetylsalicylic acid on platelet aggregation when the two drugs are administered simultaneously. Although there are uncertainties regarding the extrapolation of these data to the clinical situation, the possibility cannot be excluded that regular, long-term use of ibuprofen may reduce the cardioprotective effect of acetylsalicylic acid at low doses. No relevant clinical effects are considered likely following occasional use of ibuprofen (see section 5.1). \u003cu\u003eOther NSAIDs including selective cyclooxygenase-2 inhibitors\u003c\/u\u003e. Concomitant administration of several NSAIDs may increase the risk of gastrointestinal ulcers and bleeding due to the synergistic effect. The concomitant use of ibuprofen with other NSAIDs should therefore be avoided (see section 4.4) \u003cu\u003eDigoxin. Phenytoin, Lithium\u003c\/u\u003e. The simultaneous use of Nurofencaps with digoxin, phenytoin or lithium. may increase serum levels of these medicines. With correct use (maximum for 4 days) it is not usually necessary to control the levels of lithium, dioxin, phenytoin in the serum. \u003cu\u003eCorticosteroids\u003c\/u\u003e. Corticosteroids may increase the risk of adverse reactions, especially of the gastrointestinal tract (gastrointestinal ulceration or haemorrhage) (see section 4.3) \u003cu\u003eAntiplatelet agents and selective serotonin reuptake inhibitors (SSRIs)\u003c\/u\u003e: Increased risk of gastrointestinal bleeding (see section 4.4). \u003cu\u003eAnticoagulants\u003c\/u\u003e. NSAIDs may increase the effects of anticoagulants, such as warfarin (see section 4.4) \u003cu\u003eProbenecid and sulfinpyrazone\u003c\/u\u003e. Medicines containing probenecid or sulfinpyrazone may delay the excretion of ibuprofen \u003cu\u003eDiuretics, ACE inhibitors and Angiotensin II antagonists\u003c\/u\u003e. NSAIDs can reduce the effect of diuretics and other antihypertensive drugs. In some patients with compromised renal function (e.g. dehydrated patients or elderly patients with compromised renal function) co-administration of an ACE inhibitor, a beta-blocker or an angiotensin II antagonist and agents that inhibit the cyclo-oxygenase system may lead to further deterioration of renal function, including possible acute renal failure, which is usually reversible. Therefore, the combination should be administered with caution, especially in elderly patients. Patients should be adequately hydrated and monitoring of renal function should be considered after initiation of concomitant therapy, and periodically thereafter \u003cu\u003ePotassium-sparing diuretics\u003c\/u\u003e. Co-administration of Nurofencaps and potassium-sparing diuretics may cause hyperkalemia. \u003cu\u003eMethotrexate\u003c\/u\u003e. Administration of Nurofencaps in the 24 hours before and after the administration of methotrexate may lead to an increase in plasma levels of methotrexate and an increase in its toxic effects. \u003cu\u003eCyclosporine\u003c\/u\u003e. Coadministration with some nonsteroidal anti-inflammatory drugs increases the risk of liver injury from cyclosporine. This effect cannot also be excluded for the association of ciclosporin with ibuprofen. \u003cu\u003eTacrolimus\u003c\/u\u003e. the risk of nephrotoxicity increases if the two medicines are administered simultaneously. \u003cu\u003eZidovudine\u003c\/u\u003e. There is evidence of an increased risk of haemarthrosis and haematoma in HIV-positive haemophilia patients if treated simultaneously with zidovudine and ibuprofen. There is a risk of increased haematological toxicity when NSAIDs are administered with zidovudine. \u003cu\u003eSulfonylureas\u003c\/u\u003e Clinical investigations have highlighted interactions between non-steroidal anti-inflammatory drugs and anti-diabetics (Sulfonylureas). Although no interactions between antidiabetics and ibuprofen have been described so far, it is recommended to monitor plasma glucose levels as a precaution in case of co-administration. \u003cu\u003eQuinolone antibiotics\u003c\/u\u003e Experimental animal data indicate that NSAIDs may increase the risk of seizures associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may have an increased risk of having seizures. \u003cu\u003eMifepristone\u003c\/u\u003e: NSAIDs should not be used for 8-12 days after administration of Mifepristone as NSAIDs may reduce the effect of Mifepristone. \u003cu\u003eCYP2C9 inhibitors\u003c\/u\u003e: Concomitant administration of ibuprofen and CYP2C9 inhibitors may potentiate exposure to ibuprofen (CYP2C9 substrate). In a study with voriconazole and fluconazole (CYP2C9 inhibitors), increased exposure to S(+)-ibuprofen by approximately 80% to 100% was observed. Ibuprofen dose reduction should be considered when potent CYP2C9 inhibitors are administered concomitantly, particularly when high-dose ibuprofen is administered with voriconazole and fluconazole.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eSIDE EFFECTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eThe list of the following side effects includes all side effects that have been recognized during treatment with ibuprofen, even those observed during prolonged high-dose therapy in patients with rheumatism. The frequencies reported, which extend beyond reports of very rare side effects, refer to short periods of treatment for daily doses up to a maximum of 1200 mg of ibuprofen for oral pharmaceutical forms and up to a maximum of 1800 mg for suppositories. It should be taken into account that the following adverse reactions are predominantly dose-dependent and vary from individual to individual. The most commonly observed adverse reactions are gastrointestinal in nature. Peptic ulcers, perforation or gastrointestinal bleeding, sometimes fatal, may occur, particularly in the elderly (see section 4.4). Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease have been reported following administration of ibuprofen (see section 4.4). Less frequently, gastritis was observed. In particular, the risk of gastrointestinal bleeding depends on the dosage and duration of treatment. Edema, hypertension and heart failure have been reported in association with NSAID treatment. Clinical studies suggest that the use of ibuprofen, especially at high doses (2400 mg\/day), may be associated with a modest increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke) (see section 4.4). Hypersensitivity reactions have been reported and may manifest as: (a) non-specific allergic reactions and anaphylaxis; (b) respiratory tract reactivity, such as asthma, aggravated asthma, bronchospasm, dyspnea; (c) various skin reactions, such as pruritus, urticaria, angioedema and more rarely bullous and exfoliative dermatoses (including epidermal necrolysis and erythema multiforme). The patient should be informed to immediately inform the doctor and stop taking Nurofencaps if any of the above-mentioned adverse reactions occur. Please note that for each frequency group, side effects are presented in order of decreasing seriousness:\u003c\/p\u003e\n\u003cp\u003eVery common (≥1\/10).\u003c\/p\u003e\n\u003cp\u003eCommon (≥1\/100, \u003c1\/10).\u003c\/p\u003e\n\u003cp\u003eUncommon (≥1\/1,000, \u003c1\/100).\u003c\/p\u003e\n\u003cp\u003eRare (≥1\/10,000, \u003c1\/1,000).\u003c\/p\u003e\n\u003cp\u003eVery rare (\u003c1\/10,000).\u003c\/p\u003e\n\u003cp\u003eNot known (frequency cannot be estimated from the available data).\u003c\/p\u003e\n\u003cp\u003e\u003cb\u003eInfections and infestations.\u003c\/b\u003e Very rare: Exacerbation of infection-related inflammation (e.g. development of necrotizing fasciitis) has been described with the use of non-steroidal anti-inflammatory drugs. This is potentially associated with the mechanism of action of nonsteroidal anti-inflammatory drugs. If signs of infection appear or worsen while using Nurofencaps, the patient is recommended to contact a doctor immediately. The possible indication for anti-infective\/antibiotic therapy must be evaluated. Symptoms of aseptic meningitis such as stiff neck, headache, nausea, vomiting, fever or disorientation have been observed during treatment with ibuprofen. Patients with autoimmune disorders (systemic lupus erythematosus, mixed connective tissue disease) appear to be predisposed. \u003cb\u003ePathologies of the blood and lymphatic system\u003c\/b\u003e. Very rare: haematopoietic disorders (anaemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). The first manifestations may be: fever, sore throat, superficial ulcers of the oral cavity, flu-like symptoms, severe fatigue, nasal and skin bleeding. In these cases the patient must be informed to immediately suspend therapy, to avoid taking any analgesic or antipyretic self-medication medicines and to consult the doctor. For prolonged therapy the blood count must be checked regularly. \u003cb\u003eImmune system disorders (hypersensitivity)\u003c\/b\u003e. Uncommon: hypersensitivity reactions with urticaria and itching, as well as asthma attacks (possibly with fall in blood pressure). Very rare: severe generalized hypersensitivity reactions. Symptoms may be: swelling of the face, tongue and larynx, dyspnea, tachycardia, hypotension (anaphylaxis, angioedema or severe shock). Exacerbation of asthma and bronchospasm. \u003cb\u003ePsychiatric disorders\u003c\/b\u003e. Very rare: psychotic reactions, depression. \u003cb\u003eNervous system disorders\u003c\/b\u003e. Uncommon: central nervous system disorders such as headache, dizziness, drowsiness, agitation, irritability or tiredness. \u003cb\u003eEye pathologies\u003c\/b\u003e. Uncommon: visual disturbances. \u003cb\u003eEar and labyrinth disorders\u003c\/b\u003e. Rare: tinnitus, hearing impairment. \u003cb\u003eCardiac diseases\u003c\/b\u003e. Very rare: palpitations, heart failure, myocardial infarction. \u003cb\u003eVascular pathologies\u003c\/b\u003e. Very rare: arterial hypertension, vasculitis. \u003cb\u003eGastrointestinal disorders\u003c\/b\u003e. Common: gastrointestinal disorders such as dyspepsia, heartburn, abdominal pain, nausea, vomiting, flatulence, diarrhea, constipation and slight gastrointestinal blood loss which in exceptional cases can cause anemia; Uncommon: Gastrointestinal ulcers, potentially with perforation and gastrointestinal bleeding. Ulcerative stomatitis, exacerbation of colitis and Crohn's disease (see section 4.4), gastritis; Very rare: esophagitis, pancreatitis, formation of diaphragmatic-like intestinal strictures. The patient should be advised to discontinue the medicinal product and seek immediate medical attention if severe upper abdominal pain, melena or haematemesis occurs. \u003cb\u003eHepatobiliary disorders\u003c\/b\u003e. Very rare: liver dysfunction, liver damage, especially following long-term treatment, liver failure, acute hepatitis. \u003cb\u003ePathologies of the skin and subcutaneous tissue.\u003c\/b\u003e Uncommon: various skin rashes; Very rare: bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell's syndrome), alopecia. In exceptional cases, serious skin infections and soft tissue complications may occur during a chickenpox infection (see also “Infections and infestations”). Not known: drug reaction with eosinophilia and systemic symptoms (DRESS syndrome). Acute generalized exanthematous pustulosis (PEAG). Photosensitivity reactions. \u003cb\u003eRenal and urinary disorders\u003c\/b\u003e. Rare: Kidney tissue damage (papillary necrosis) and high concentrations of uric acid in the blood may rarely occur. High concentrations of urea in the blood; Very rare: edema formation, particularly in patients with arterial hypertension or renal failure, nephrotic syndrome, interstitial nephritis which may be accompanied by acute renal failure. Kidney function should therefore be checked regularly. \u003cu\u003eReporting of suspected adverse reactions\u003c\/u\u003e Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit\/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.aifa.gov.it\/content\/segnalazioni-reazioni-avverse. \u003cu\u003eDiagnostic tests\u003c\/u\u003e. Rare: decreased hemoglobin levels.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eOVERDOSE\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eIn adults and adolescents there is no obvious dose-response effect. The half-life in case of overdose is 1.5-3 hours. \u003cu\u003eSymptoms\u003c\/u\u003e Most patients who have ingested clinically relevant quantities of NSAIDs present exclusively nausea, vomiting, epigastric pain, or more rarely diarrhea. You may also experience tinnitus, headache, and gastrointestinal bleeding. In more severe cases of poisoning, central nervous system toxicity is observed, manifested by dizziness, drowsiness, occasionally excitation and disorientation or coma. Occasionally patients develop seizures. In severe cases of poisoning, metabolic acidosis and a prolongation of the prothrombin time\/INR may occur, probably caused by interference with the action of coagulation factors present in the circulation. Acute renal failure and liver damage may also occur. In asthmatic subjects, asthma exacerbation may occur. \u003cu\u003eTreatment\u003c\/u\u003e Treatment should be symptomatic and supportive and should include maintaining a patent airway and monitoring cardiac function and vital signs until the patient is stabilized. Oral administration of activated charcoal should be considered if the patient presents within 1 hour of ingesting a potentially toxic quantity. Seizures should be treated with intravenous diazepam or lorazepam if they are frequent or prolonged. Administer bronchodilators in case of asthma. There is no specific antidote available.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003ePREGNANCY AND BREASTFEEDING\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cu\u003ePregnancy\u003c\/u\u003e Inhibition of prostaglandin synthesis can negatively affect pregnancy and\/or embryo\/foetal development. Data obtained from epidemiological studies suggest an increased risk of miscarriage, cardiac malformation and gastroschisis after the use of a prostaglandin synthesis inhibitor during the early stages of pregnancy. The absolute risk of cardiac malformations increased from less than 1% to approximately 1.5%. The risk is thought to increase with the dose and duration of therapy. In animals, the administration of prostaglandin synthesis inhibitors has been shown to cause an increase in pre- and post-implantation loss and embryo-fetal mortality. Furthermore, an increased incidence of various malformations, including cardiovascular malformations, has been reported in animals to which prostaglandin synthesis inhibitors were administered during the organogenetic period. During the first and second trimester of pregnancy, ibuprofen should not be administered unless strictly necessary. When used by women about to conceive or during the first and second trimester of pregnancy, the dose and duration of treatment should be as low and as short as possible, respectively. During the third trimester of pregnancy, all inhibitors of prostaglandin synthesis can expose the fetus to: - cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension); - renal dysfunction which may progress to renal failure with oligohydramniosis; the mother and newborn, at the end of pregnancy, to: - possible prolongation of bleeding time, an anti-aggregating effect which can occur even at very low doses; - inhibition of uterine contractions resulting in delayed or prolonged labor. Consequently, ibuprofen is contraindicated during the third trimester of pregnancy. \u003cu\u003eBreastfeeding\u003c\/u\u003e Ibuprofen and its metabolites can pass in low concentrations into breast milk. No dangerous effects for newborns are known to date, therefore for short treatments with the recommended dose for pain and fever, interruption of breastfeeding is generally not necessary. \u003cu\u003eFertility\u003c\/u\u003e There is some evidence that drugs that inhibit cyclooxygenase\/prostaglandin synthesis may cause impairment of female fertility with an effect on ovulation. This is reversible upon discontinuation of treatment (see section 4.4).\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eEFFECTS ON DRIVING ABILITY\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003ePatients who experience dizziness, drowsiness, vertigo or visual disturbances during ibuprofen therapy should avoid driving or using machinery. For a single administration or short periods of treatment, ibuprofen does not normally require the adoption of any special precautions. These effects are even more enhanced in case of concomitant alcohol intake.\u003c\/p\u003e","brand":"Reckitt Benckiser","offers":[{"title":"Default Title","offer_id":51131308933447,"sku":"041860053","price":10.51,"currency_code":"EUR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0564\/4989\/2467\/files\/reckitt-benckiser-h-it-spa-nurofencaps-400mg-10-capsule-molli-farmacia-dottor-tili-1213792149.jpg?v=1767135149"},{"product_id":"nurofen-200mg-24-compresse-rivestite","title":"Nurofen 200mg 24 coated tablets","description":"\u003cp\u003e\u003cstrong\u003eINDICATIONS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003ePain of various kinds: headache, toothache, neuralgia, muscular and osteoarticular pain, menstrual pain. Adjuvant in the symptomatic treatment of feverish and flu states. Nurofen is indicated in adults and adolescents over 12 years of age\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eACTIVE INGREDIENTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e200 mg coated tablets: each tablet contains 200 mg of ibuprofen 400 mg coated tablets: each tablet contains 400 mg of ibuprofen Excipients with known effects: Each 200 mg coated tablet contains: - 116.1 mg of sucrose, equivalent to approximately 0.34 mmol - 17.34 mg of sodium, equivalent to approximately 0.75 mmol Each 400 mg coated tablet contains: - 232.2 mg, equivalent to approximately 0.68 mmol - 34.69 mg sodium, equivalent to approximately 1.51 mmol. For the full list of excipients, see section 6.1.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eEXCIPIENTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cb\u003eNurofen 200 mg coated tablets\u003c\/b\u003e Croscarmellose sodium, \u003cb\u003esodium\u003c\/b\u003e lauryl sulfate, \u003cb\u003esodium\u003c\/b\u003e citrate, stearic acid, colloidal anhydrous silica, carmellose \u003cb\u003esodium\u003c\/b\u003e, talc, dried atomized gum arabic, \u003cb\u003esucrose\u003c\/b\u003e, titanium dioxide, macrogol 6000, ink (shellac, black iron oxide E172, propylene glycol E1520). \u003cb\u003eNurofen 400 mg coated tablets\u003c\/b\u003e Croscarmellose \u003cb\u003esodium\u003c\/b\u003e, \u003cb\u003esodium\u003c\/b\u003e lauryl sulfate, \u003cb\u003esodium\u003c\/b\u003e citrate, stearic acid, colloidal anhydrous silica, carmellose \u003cb\u003esodium\u003c\/b\u003e, talc, dried atomized gum arabic, \u003cb\u003esucrose\u003c\/b\u003e, titanium dioxide, macrogol 6000, ink (shellac, red iron oxide (E 172), propylene glycol (E1520), ammonium hydroxide (E527), simethicone).\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eCONTRAINDICATIONS AND SIDE EFFECTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eHypersensitivity to the active substance or to any of the excipients, listed in paragraph 6.1. Patients who have previously experienced hypersensitivity reactions (e.g. bronchospasm, asthma, rhinitis, angioedema or urticaria) following the use of ibuprofen, acetylsalicylic acid, or other non-steroidal anti-inflammatory products (NSAIDs). Patients with severe hepatic or renal impairment (see section 4.4). Severe heart failure (NYHA class IV) Patients with a history of gastrointestinal bleeding or perforation, related to previous NSAID therapy. Patients with current or previous recurrent peptic ulcers\/haemorrhages (two or more distinct episodes of proven ulceration or bleeding). During the last trimester of pregnancy (see section 4.6). Children under 12 years old. Before or after cardiac surgery.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eDOSAGE\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cu\u003eDosage \u003c\/u\u003e Only for a short period of treatment. Undesirable effects can be minimized by using the lowest effective dose for the shortest possible treatment duration needed to control symptoms (see section 4.4). If symptoms persist or worsen after a short period of treatment, consult your doctor. If the use of the medicine is necessary for more than 3 days in adolescents, or in the case of worsening of symptoms, the doctor should be consulted. \u003cb\u003e \u003cu\u003eNUROFEN 200 mg coated tablets\u003c\/u\u003e \u003c\/b\u003e \u003cb\u003e Pediatric population:\u003c\/b\u003e Do not administer to children under 12 years of age.\u003cb\u003eAdults and adolescents over 12 years old\u003c\/b\u003e: 1-2 tablets, 2-3 times a day. The interval between doses should not be less than 4 hours. Do not exceed a dose of 1200 mg (6 tablets) in 24 hours. \u003cb\u003eElderly\u003c\/b\u003e: No changes to the dosage schedule are required. \u003cb\u003e \u003cu\u003eNUROFEN 400 mg coated tablets\u003c\/u\u003e \u003c\/b\u003e \u003cb\u003ePediatric population:\u003c\/b\u003e Do not administer to children under 12 years of age.\u003cb\u003eAdults and adolescents over 12 years old\u003c\/b\u003e One tablet 2-3 times a day. The interval between doses should not be less than 4 hours. Do not exceed a dose of 1200 mg (3 tablets) in 24 hours. \u003cb\u003eElderly:\u003c\/b\u003e No changes to the dosage schedule are required. \u003cu\u003eMethod of administration \u003c\/u\u003e Oral use Patients with gastric sensitivity problems are advised to take Nurofen on a full stomach.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eCONSERVATION\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eNurofen 400 mg coated tablets: store at a temperature not exceeding 30°C.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eWARNINGS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eCaution is required in patients with coagulation defects. Side effects can be minimized by using the lowest effective dose for the shortest possible treatment duration needed to control symptoms (see gastrointestinal and cardiovascular risks below). \u003cb\u003eElderly\u003c\/b\u003e: Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which may be fatal (see section 4.2). \u003cb\u003ePediatric population\u003c\/b\u003e: in dehydrated adolescents there is a risk of impaired renal function. \u003cb\u003eRespiratory disorders\u003c\/b\u003e: bronchospasm may occur in patients with bronchial asthma or current or previous allergic diseases. \u003cb\u003eOther NSAIDs\u003c\/b\u003e: The use of Nurofen should be avoided concomitantly with other NSAIDs, including selective cyclooxygenase-2 inhibitors. (see paragraph 4.5) \u003cb\u003eSLE and mixed connective tissue disease\u003c\/b\u003e Systemic lupus erythematosus and with mixed connective tissue disease due to increased risk of aseptic meningitis (see section 4.8); \u003cb\u003eCardiovascular and cerebrovascular effects\u003c\/b\u003e: caution is required (discuss with your doctor or pharmacist) before starting treatment in patients with a positive history of hypertension and\/or heart failure since fluid retention, hypertension and edema have been reported in association with treatment with NSAIDs. Clinical studies suggest that the use of ibuprofen, especially at high doses (2400 mg\/day), may be associated with a modest increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke). In general, epidemiological studies do not suggest that low doses of ibuprofen (e.g. ≤ 1200 mg\/day) are associated with an increased risk of arterial thrombotic events. Patients with uncontrolled hypertension, congestive heart failure (NYHA class II-III), established ischemic heart disease, peripheral arterial disease and\/or cerebrovascular disease should be treated with ibuprofen only after careful consideration and high doses (2400 mg\/day) should be avoided. Careful consideration must also be exercised before starting long-term treatment for patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidemia, diabetes mellitus, cigarette smoking habit), especially if high doses (2400 mg\/day) of ibuprofen are necessary. \u003cb\u003eLiver or kidney function:\u003c\/b\u003e • renal failure, as renal function may be compromised (see sections 4.3 and 4.8). In general, the habitual use of analgesics, especially combinations of different analgesic active ingredients, can lead to permanent kidney damage with the risk of the onset of renal failure (analgesic nephropathy). • liver dysfunction (see sections 4.3 and 4.8). Particular caution should be taken when treating patients with reduced hepatic or renal function. In such patients it is advisable to resort to periodic monitoring of clinical and laboratory parameters, especially in case of prolonged treatment. \u003cb\u003eCompromised female fertility\u003c\/b\u003e: Administration of Nurofen should be avoided in women planning pregnancy (see section 4.6). \u003cb\u003eGastrointestinal safety\u003c\/b\u003e: NSAIDs should be administered with caution to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated (see section 4.8). Gastrointestinal haemorrhage, ulceration and perforation, which may be fatal, have been reported during treatment with all NSAIDs at any time, with or without warning symptoms or previous history of serious gastrointestinal events. In the elderly and in patients with a history of ulcer, especially if complicated by haemorrhage or perforation (see section 4.3), the risk of gastrointestinal haemorrhage, ulceration or perforation is higher with increased doses of NSAIDs. These patients should start treatment with the lowest available dose. The concomitant use of protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients and also for patients taking low doses of acetylsalicylic acid or other drugs that may increase the risk of gastrointestinal events (see section 4.5). Patients with a history of gastrointestinal toxicity, particularly the elderly, should report any unusual gastrointestinal symptoms (especially gastrointestinal haemorrhage) particularly in the initial stages of treatment. Caution should be exercised in patients taking concomitant medications that may increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or antiplatelet agents such as acetylsalicylic acid (see section 4.5). When gastrointestinal bleeding or ulceration occurs in patients taking Nurofen, treatment should be discontinued. \u003cb\u003eSevere skin reactions:\u003c\/b\u003e Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported rarely in association with the use of NSAIDs (see section 4.8). Patients appear to be at higher risk in the early stages of therapy: the onset of the reaction occurs in most cases within the first month of treatment. Acute generalized exanthematous pustulosis (PEAG) has been reported in connection with ibuprofen-containing medicinal products. Ibuprofen should be discontinued at the first appearance of signs and symptoms of severe skin reactions, such as rash, mucosal lesions or any other sign of hypersensitivity. \u003cb\u003eMasking of symptoms of underlying infections\u003c\/b\u003e: Nurofen may mask the symptoms of infection, which may delay the initiation of appropriate treatment and therefore worsen the outcome of the infection. This has been observed in community-acquired bacterial pneumonia and bacterial complications of chickenpox. When Nurofen is given for the relief of fever or pain related to infection, monitoring of the infection is advised. In non-hospital settings, the patient should seek medical attention if symptoms persist or worsen. \u003cb\u003eOther:\u003c\/b\u003e during prolonged treatments with analgesic medicinal products at doses higher than those indicated, headaches may occur which must not be treated with higher doses of the product. Alcohol consumption should be avoided as it can intensify the side effects of NSAIDs, especially those affecting the gastrointestinal tract or central nervous system. At the first signs of hypersensitivity reaction after administration of ibuprofen, treatment should be discontinued. Medically assisted measures must be initiated by specialized medical personnel, in line with the symptoms. Acid ibuprofen can cause a prolongation of the bleeding time by reversibly inhibiting the aggregation of platelets. \u003cb\u003eImportant information about some excipients\u003c\/b\u003e \u003cu\u003eNurofen\u003c\/u\u003e contains sucrose: patients suffering from rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase isomaltase insufficiency should not take this medicine. \u003cu\u003eNurofen 200 mg coated tablets\u003c\/u\u003e contains sodium: this medicine contains less than 1 mmol (23 mg) sodium per tablet (17.34 mg), i.e. essentially 'sodium-free' and just over 1 mmol (23 mg) sodium per 2 tablets (34.68 mg), equivalent to 1.73% of the maximum daily intake recommended by the WHO which corresponds to 2 g sodium for an adult. \u003cu\u003eNurofen 400 mg coated tablets contain sodium\u003c\/u\u003e: This medicine contains 34.69 mg sodium per tablet, equivalent to 1.73% of the WHO recommended maximum daily intake of 2 g sodium for an adult.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eINTERACTIONS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eIbuprofen should be avoided in association with: - Acetylsalicylic acid: concomitant administration of ibuprofen and acetylsalicylic acid is generally not recommended due to the potential for increased side effects (see section 4.4). Experimental data suggest that ibuprofen can competitively inhibit the effect of low-dose acetylsalicylic acid on platelet aggregation when the two drugs are administered simultaneously. Although there are uncertainties regarding the extrapolation of these data to the clinical situation, the possibility cannot be excluded that regular, long-term use of ibuprofen may reduce the cardioprotective effect of acetylsalicylic acid at low doses. No relevant clinical effects are considered likely following occasional use of ibuprofen (see section 5.1). - Other NSAIDs including selective cyclooxygenase-2 inhibitors: the concomitant use of two or more NSAIDs should be avoided as they may increase the risk of adverse reactions affecting the gastrointestinal tract (see section 4.4). Ibuprofen (like other NSAIDs) should be used with caution in association with: - Corticosteroids: increased risk of gastrointestinal ulceration or haemorrhage (see section 4.4) - Anticoagulants: NSAIDs may increase the effects of anticoagulants, such as warfarin (see section 4.4) - Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal haemorrhage (see section 4.4). - Antihypertensives (ACE inhibitors and Angiotensin II Antagonists), diuretics and beta blockers: NSAIDs can reduce the effect of diuretics and other antihypertensive drugs. In some patients with compromised renal function (e.g. dehydrated patients or elderly patients with compromised renal function) co-administration of an ACE inhibitor or an angiotensin II antagonist and agents that inhibit the cyclo-oxygenase system may lead to further deterioration of renal function, including possible acute renal failure, which is usually reversible. These interactions should be considered in patients taking a coxib (such as Nurofen) concomitantly with ACE inhibitors or angiotensin II antagonists. Therefore, the combination should be administered with caution, especially in elderly patients. Patients should be adequately hydrated and consideration should be given to monitoring renal function after initiation of concomitant therapy and at regular intervals thereafter. Diuretics may increase the risk of NSAID nephrotoxicity. - Cardiac glycosides: NSAIDs can worsen heart failure, reduce GFR (glomerular filtration rate) and increase plasma levels of glycosides. - Lithium. There are demonstrations of the possibility of a potential increase in lithium levels in the blood, with the possibility of reaching the toxic threshold. If this combination is necessary, monitor lithium levels in order to adapt the lithium dosage during simultaneous treatment with ibuprofen. - Methotrexate. There is evidence of the possibility of an increase in plasma levels of methotrexate. - Cyclosporins: increase the risk of nephrotoxicity. - Mifepristone: NSAIDs should not be taken for 8-12 days after administration of Mifepristone as NSAIDs may reduce the effects of Mifepristone. - Tacrolimus: possible increased risk of nephrotoxicity when NSAIDs are administered with Tacrolimus. - Zidovudine: increased risk of haematological toxicity when NSAIDs are administered with Zidovudine. There is evidence of an increased risk of haemarthrosis and haematoma in HIV-positive haemophilia patients if treated simultaneously with zidovudine and ibuprofen. - Antibiotics quinolones: Data from animal studies indicate that NSAIDs may increase the risk of seizures associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may have an increased risk of developing seizures. - Alcohol, bisphosphonates and pentoxifylline: can potentiate gastrointestinal side effects and the risk of bleeding and ulcers. - Baclofen: high toxicity of baclofen.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eSIDE EFFECTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eThe list of the following side effects includes side effects that have been observed during treatment with ibuprofen at self-medication doses (up to a maximum of 1200mg per day). In case of chronic conditions, additional side effects may occur during long-term treatment. The side effects associated with the administration of ibuprofen are listed below according to system organ classification and frequency. \u003ci\u003eFor the frequency of occurrence of side effects, the following expressions are used:\u003c\/i\u003e \u003ci\u003eVery common (\u003c\/i\u003e≥ \u003ci\u003e1\/10)\u003c\/i\u003e; \u003ci\u003eMunicipality (\u003c\/i\u003e≥ \u003ci\u003e1\/100, \u0026lt;1\/10)\u003c\/i\u003e; \u003ci\u003eUncommon (\u003c\/i\u003e≥ \u003ci\u003e1\/1000, \u0026lt;1\/100)\u003c\/i\u003e; \u003ci\u003eRare (\u003c\/i\u003e≥ \u003ci\u003e1\/10.000, \u0026lt;1\/1000)\u003c\/i\u003e; \u003ci\u003eVery rare (\u003c1\/10,000)\u003c\/i\u003e; \u003ci\u003eNot known (frequency cannot be estimated from the available data)\u003c\/i\u003e. \u003ci\u003eWithin each frequency grouping, undesirable effects are presented in order of decreasing seriousness.\u003c\/i\u003e\u003c\/p\u003e\n\u003cp\u003eBlood and lymphatic system disorders - Frequency: Very Rare. Adverse Reaction: Hematopoietic disorders¹\u003c\/p\u003e\n\u003cp\u003eImmune system disorders - Frequency: Uncommon. Adverse Reaction: Hypersensitivity reactions including urticaria and pruritus²\u003c\/p\u003e\n\u003cp\u003eImmune system disorders - Frequency: Very Rare. Adverse Reaction: Severe hypersensitivity reactions including swelling of the face, tongue and throat, dyspnoea, tachycardia, hypotension (anaphylaxis, angioedema or severe shock)²\u003c\/p\u003e\n\u003cp\u003eNervous system disorders - Frequency: Uncommon. Adverse Reaction: Headache, dizziness.\u003c\/p\u003e\n\u003cp\u003eNervous system disorders - Frequency: Rare. Adverse Reaction: Cerebrovascular accident9.\u003c\/p\u003e\n\u003cp\u003eNervous system disorders - Frequency: Very rare. Adverse Reaction: Aseptic meningitis³\u003c\/p\u003e\n\u003cp\u003eEye disorders - Frequency: Very Rare. Adverse Reaction: Visual disturbances.\u003c\/p\u003e\n\u003cp\u003eCardiac disorders - Frequency: Very rare. Adverse Reaction: Heart failure and edema4.\u003c\/p\u003e\n\u003cp\u003eVascular disorders - Frequency: Very rare. Adverse Reaction: Hypertension4.\u003c\/p\u003e\n\u003cp\u003eRespiratory, thoracic and mediastinal disorders - Frequency: Not known. Adverse Reaction: Respiratory tract reactivity including asthma, worsening of asthma, bronchospasm or dyspnea.\u003c\/p\u003e\n\u003cp\u003eGastrointestinal disorders - Frequency: Uncommon. Adverse Reaction: Dyspepsia, abdominal pain and nausea5.\u003c\/p\u003e\n\u003cp\u003eGastrointestinal disorders - Frequency: Rare. Adverse Reaction: Diarrhoea, flatulence, constipation and vomiting.\u003c\/p\u003e\n\u003cp\u003eGastrointestinal disorders - Frequency: Very rare. Adverse Reaction: Peptic ulcers, gastrointestinal perforation or hemorrhage, melena, hematemesis6, ulcerative stomatitis, gastritis.\u003c\/p\u003e\n\u003cp\u003eGastrointestinal disorders - Frequency: Not known. Adverse Reaction: Exacerbation of colitis and Crohn's disease7, pancreatitis.\u003c\/p\u003e\n\u003cp\u003eHepatobiliary disorders - Frequency: Rare. Adverse Reaction: Hepatotoxicity\u003c\/p\u003e\n\u003cp\u003eHepatobiliary disorders - Frequency: Very rare. Adverse Reaction: Liver disorders, especially following long-term treatment, hepatitis, jaundice.\u003c\/p\u003e\n\u003cp\u003eSkin and subcutaneous tissue disorders - Frequency: Uncommon. Adverse Reaction: Skin rashes².\u003c\/p\u003e\n\u003cp\u003eSkin and subcutaneous tissue disorders - Frequency: Very rare. Adverse Reaction: Erythema multiforme, bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis.²\u003c\/p\u003e\n\u003cp\u003eSkin and subcutaneous tissue disorders - Frequency: Not known. Adverse Reaction: Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), acute generalized exanthematous pustulosis (PEAG), photosensitivity reactions\u003c\/p\u003e\n\u003cp\u003eRenal and urinary disorders - Frequency: Very rare. Adverse Reaction: Acute renal failure8, hematuria, nephritis, nephrotic syndrome9.\u003c\/p\u003e\n\u003cp\u003eDiagnostic tests - Frequency: Rare. Adverse Reaction: Increased transaminases, increased alkaline phosphatase, decreased hematocrit, prolonged bleeding time, decreased blood calcium, increased uric acid.\u003c\/p\u003e\n\u003cp\u003eDiagnostic tests - Frequency: Very rare. Adverse Reaction: Decreased hemoglobin level in the blood.\u003c\/p\u003e\n\u003cp\u003e\u003cb\u003eDescription of some side effects\u003c\/b\u003e \u003csup\u003e1\u003c\/sup\u003e Examples include anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). The first manifestations are: fever, sore throat, superficial ulcers of the oral cavity, flu-like symptoms, severe fatigue, bruises and unexplained bleeding. ² Hypersensitivity reactions: these reactions may include a) non-specific allergic reactions and anaphylaxis, b) respiratory tract reactivity including asthma, worsening of asthma, bronchospasm or dyspnoea or c) various skin conditions such as various skin rashes, pruritus, urticaria, purpura, angioedema and very rarely bullous and exfoliative dermatitis including toxic epidermal necrolysis, Stevens-Johnson syndrome and erythema multiforme. ³ The pathogenesis of drug-induced aseptic meningitis is not completely understood. However, the data available on aseptic meningitis related to the administration of NSAIDs leads us to think of an immune hypersensitivity reaction (due to a temporary relationship with the intake of the medicine and the disappearance of symptoms after discontinuation of treatment). Of note, individual cases of aseptic meningitis symptoms (such as stiff neck, headache, nausea, vomiting, fever and disorientation) have been observed during treatment with ibuprofen in patients with autoimmune disorders (such as systemic lupus erythematosus, mixed connective tissue disease). \u003csup\u003e4\u003c\/sup\u003e Clinical studies suggest that the use of ibuprofen, especially at high doses (2400 mg\/day) may be associated with a modest increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke) (see section 4.4) \u003csup\u003e5\u003c\/sup\u003e The most commonly observed adverse reactions are gastrointestinal in nature. \u003csup\u003e6\u003c\/sup\u003e sometimes fatal, particularly in the elderly \u003csup\u003e7\u003c\/sup\u003e see paragraph 4.4 \u003csup\u003e8\u003c\/sup\u003e particularly following long-term treatment, associated with increased serum urea concentrations. Decreased urea excretion and edema. Also includes papillary necrosis \u003csup\u003e9\u003c\/sup\u003e reported as an effect of NSAID class \u003cb\u003eReporting of suspected adverse reactions\u003c\/b\u003e Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit\/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at: https:\/\/www.aifa.gov.it\/content\/segnalazioni-reazioniavverse.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eOVERDOSE\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cu\u003eToxicity \u003c\/u\u003e Signs and symptoms of toxicity were generally not observed at doses below 100 mg\/kg in children or adults. However, in some cases supportive treatment may be necessary. Children have been observed to exhibit signs and symptoms of toxicity after ingesting ibuprofen at doses of 400 mg\/kg or greater. \u003cu\u003eSymptoms \u003c\/u\u003e Most patients who have ingested significant amounts of ibuprofen will experience symptoms within 4 to 6 hours. The most commonly reported overdose symptoms include: nausea, vomiting, abdominal pain, lethargy, and drowsiness. Central nervous system (CNS) effects include headache, tinnitus, dizziness, seizures, and loss of consciousness. Nystagmus, metabolic acidosis, hypothermia, renal effects, gastrointestinal bleeding, coma, apnea, diarrhea and depression of the CNS and respiratory system, blurring of vision have also been reported rarely. Disorientation, arousal, fainting and cardiovascular toxicity including hypotension, bradycardia and tachycardia have been reported. In cases of significant overdose, renal failure and liver damage are possible. In cases of severe poisoning, metabolic acidosis and a prolongation of the prothrombin time\/INR may occur, probably caused by interference with the action of coagulation factors present in the circulation. In asthmatic subjects, asthma exacerbation may occur. \u003cu\u003eTreatment \u003c\/u\u003e There is no specific antidote for ibuprofen overdose. In case of overdose, symptomatic and supportive treatment is therefore indicated and must include maintaining a patent airway and monitoring cardiac function and vital signs until the patient is stabilised. Particular attention is due to the control of blood pressure, acid-base balance and any gastrointestinal bleeding. Administration of activated charcoal should be considered within one hour of ingesting a potentially toxic quantity. Alternatively, in adults, gastric lavage should be considered within one hour of ingestion of a potentially life-threatening overdose. Adequate diuresis must be ensured and renal and hepatic functions must be closely monitored. The patient must remain under observation for at least four hours following ingestion of a potentially toxic amount of drug. Any occurrence of frequent or prolonged convulsions should be treated with intravenous diazepam. If ibuprofen has already been absorbed, alkaline substances should be administered to promote excretion of the acidic ibuprofen in the urine. Administer bronchodilators in case of asthma. Depending on the patient's clinical condition, other support measures may be necessary. For more information, contact your local poison control center.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003ePREGNANCY AND BREASTFEEDING\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cu\u003ePregnancy\u003c\/u\u003e Inhibition of prostaglandin synthesis can negatively affect the pregnant woman and\/or embryo\/foetal development. Data obtained from epidemiological studies suggest an increased risk of miscarriage, cardiac malformation and gastroschisis after the use of a prostaglandin synthesis inhibitor during early pregnancy. The absolute risk of cardiac malformations increased from less than 1% to approximately 1.5%. The risk is thought to increase with the dose and duration of therapy. In animals, the administration of prostaglandin synthesis inhibitors has been shown to cause an increase in pre- and post-implantation loss and embryo-foetal mortality. Furthermore, an increased incidence of various malformations, including cardiovascular malformations, has been reported in animals to which prostaglandin synthesis inhibitors were administered during the organogenetic period. From the 20th\u003csup\u003ea\u003c\/sup\u003e week of pregnancy onwards, the use of ibuprofen could cause oligohydramnios resulting from fetal renal dysfunction. This condition may be experienced shortly after starting treatment and is usually reversible upon discontinuation of treatment. Additionally, cases of constriction of the ductus arteriosus have been reported following treatment in the second trimester, most of which resolved after treatment was discontinued. Therefore, during the first and second trimester of pregnancy ibuprofen should not be administered unless strictly necessary. If ibuprofen is used by a woman planning pregnancy, or during the first and second trimester of pregnancy, the lowest possible dose should be used for the shortest possible time. Following exposure to ibuprofen for several days from the 20th\u003csup\u003ea\u003c\/sup\u003e week of gestation onwards, antenatal monitoring for oligohydramnios and ductus arteriosus constriction should be considered. In case of oligohydramnios or constriction of the ductus arteriosus, treatment with ibuprofen should be discontinued. During the third trimester of pregnancy, all inhibitors of prostaglandin synthesis can expose the fetus to: - cardiopulmonary toxicity (premature constriction\/closure of the ductus arteriosus and pulmonary hypertension); - renal dysfunction (see above); the mother and the newborn, at the end of pregnancy, to: - possible prolongation of bleeding time, an anti-aggregating effect which can occur even at very low doses; - inhibition of uterine contractions resulting in delayed or prolonged labor. Consequently, Nurofen is contraindicated during the third trimester of pregnancy (see sections 4.3 and 5.3). \u003cu\u003eBreastfeeding \u003c\/u\u003e Ibuprofen and its metabolites can pass in low concentrations into breast milk. No dangerous effects for newborns are known to date, therefore for short treatments with the recommended dose for pain and fever, interruption of breastfeeding is generally not necessary. \u003cu\u003eFertility \u003c\/u\u003e There is evidence that medicinal products that inhibit the synthesis of cyclooxygenase\/prostaglandins can cause a weakening of female fertility by affecting ovulation. This effect is reversible after discontinuation of treatment. The administration of Nurofen should be suspended in women who have fertility problems or who are undergoing fertility investigations.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eEFFECTS ON DRIVING ABILITY\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eFor short periods of treatment, Nurofen has no or negligible influence on the ability to drive and use machinery.\u003c\/p\u003e","brand":"Reckitt Benckiser","offers":[{"title":"Default Title","offer_id":51131311653191,"sku":"025634041","price":11.53,"currency_code":"EUR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0564\/4989\/2467\/files\/reckitt-benckiser-h-it-spa-nurofen-200mg-24-compresse-rivestite-farmacia-dottor-tili-1213792139.jpg?v=1767135310"},{"product_id":"nurofen-febbre-e-dolore-bambini-100-mg-5-ml-150-ml-sospensione-senza-zucchero-gusto-arancia-con-siringa","title":"Nurofen fever and pain children 100 mg\/5 ml 150 ml sugar-free suspension orange flavour with syringe","description":"\u003cp\u003e\u003cstrong\u003eINDICATIONS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eSymptomatic treatment of fever, including post-vaccination fever, and mild or moderate pain (such as headache, toothache, sore throat, earache).\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eACTIVE INGREDIENTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eNUROFEN FEVER AND PAIN Children 100mg\/5ml Oral Suspension Each ml of oral suspension contains: Active ingredient: ibuprofen 20 mg. Excipients with known effects: liquid maltitol, propylene glycol (present in the strawberry flavour), wheat starch (present in the orange flavour) and sodium. For the full list of excipients, see section 6.1.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eEXCIPIENTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cu\u003eNurofen Fever and Pain Children 100mg\/5ml oral suspension orange flavor without sugar\u003c\/u\u003e Polysorbate 80, glycerin, maltitol syrup, sodium saccharin, citric acid, sodium citrate, xanthan gum, sodium chloride, orange flavor, domiphene bromide, purified water. \u003cu\u003eNurofen Fever and Pain Children 100mg\/5ml oral suspension strawberry flavor without sugar\u003c\/u\u003e Polysorbate 80, glycerin, maltitol syrup, sodium saccharin, citric acid, sodium citrate, xanthan gum, sodium chloride, strawberry flavor, domiphene bromide, purified water.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eCONTRAINDICATIONS AND SIDE EFFECTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e• Hypersensitivity to ibuprofen or to any of the excipients listed in section 6.1. • Children younger than 3 months or weighing less than 5.6 kg. • The medicine is contraindicated in patients who show or have previously shown hypersensitivity (e.g. asthma, rhinitis, angioedema or urticaria) to acetylsalicylic acid or other analgesics, antipyretics, non-steroidal anti-inflammatory drugs (NSAIDs), in particular when hypersensitivity is associated with nasal polyposis and asthma. • Active peptic ulcer. • Severe renal or hepatic impairment (see section 4.4). • Severe heart failure (see section 4.4). • History of gastrointestinal hemorrhage or perforation, related to previous NSAID-based therapy. History of recurrent hemorrhage\/peptic ulcer (two or more distinct episodes of demonstrated ulceration or bleeding). • Concomitant use of NSAIDs, including specific COX-2 inhibitors. • Patients with a history of cerebrovascular bleeding or other active bleeding. • Patients with unclear blood formation disorders. • Patients with severe dehydration (caused by vomiting, diarrhea or insufficient fluid intake). • During the last trimester of pregnancy (see section 4.6).\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eDOSAGE\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cu\u003eDosage \u003c\/u\u003e The daily dose is structured based on the weight and age of the patient. Undesirable effects can be minimized by using the lowest effective dose for the shortest possible treatment duration needed to control symptoms (see section 4.4). In children aged between 3 and 6 months, limit administration to those weighing more than 5.6 kg. \u003cu\u003eMethod of administration \u003c\/u\u003e Oral administration to infants and children aged between 3 months and 12 years should take place using the measuring syringe or measuring spoon supplied with the product. Patients suffering from stomach problems can take the medicine with meals. The daily dose of 20-30 mg\/kg of body weight, divided 3 times a day at 6-8 hour intervals, can be administered based on the following schedule (do not exceed the recommended doses). The graduated scale on the body of the syringe highlights the notches for the different dosages; in particular the 2.5 ml mark corresponding to 50 mg of ibuprofen and the 5 ml mark corresponding to 100 mg of ibuprofen. The measuring spoon has two marks for two different doses: the 2.5 ml mark corresponding to 50 mg of ibuprofen and the 5 ml mark corresponding to 100 mg of ibuprofen.\u003c\/p\u003e\n\u003cp\u003eWeight: From 5.6 kg - Approximate age: 3 - 6 months. Single dose in ml: 2.5 ml. maximum number of administrations\/day: 3 in 24 hours.\u003c\/p\u003e\n\u003cp\u003eWeight: From 7 Kg - Approximate age: 6 - 12 months. Single dose in ml: 2.5 ml. maximum number of administrations\/day: 3 in 24 hours.\u003c\/p\u003e\n\u003cp\u003eWeight: From 10 Kg - Approximate age: 1 - 3 years. Single dose in ml: 5 ml. maximum number of administrations\/day: 3 in 24 hours.\u003c\/p\u003e\n\u003cp\u003eWeight: From 15 Kg - Approximate age: 4 - 6 years. Single dose in ml: 7.5 ml (5 ml + 2.5 ml). maximum number of administrations\/day: 3 in 24 hours.\u003c\/p\u003e\n\u003cp\u003eWeight: From 20 kg - Approximate age: 7 - 9 years. Single dose in ml: 10 ml. maximum number of administrations\/day: 3 in 24 hours.\u003c\/p\u003e\n\u003cp\u003eWeight: From 28 to 43 Kg - Approximate age: 10 - 12 years. Single dose in ml: 15 ml. maximum number of administrations\/day: 3 in 24 hours.\u003c\/p\u003e\n\u003cp\u003eIn the case of post-vaccination fever, refer to the daily dosage recommended in the table above. The product is intended for short-term treatments. In infants aged between 3 and 5 months, the doctor should be consulted if symptoms persist for more than 24 hours or in the case of worsening of symptoms. If the use of the medicine is necessary for more than 3 days in infants and children over 6 months of age and in adolescents, or in the case of worsening of symptoms, a doctor should be consulted. \u003cu\u003eInstructions for using the dosing syringe\u003c\/u\u003e: 1. Unscrew the cap by pushing it downwards and turning it to the left. 2. Insert the tip of the syringe fully into the hole in the undercap. 3. Shake well. 4. Turn the bottle upside down, then, holding the syringe firmly, gently pull the plunger downwards, allowing the suspension to flow into the syringe up to the mark corresponding to the desired dose. 5. Place the bottle back upright and remove the syringe by gently twisting it. 6. Introduce the tip of the syringe into the child's mouth, and apply slight pressure on the plunger to let the suspension flow out. 7. After use, screw the cap to close the bottle and wash the syringe with hot water. Leave it to dry, keeping it out of the reach and sight of children.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eCONSERVATION\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eNo details.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eWARNINGS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eSide effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see paragraphs below on gastrointestinal and cardiovascular risks). \u003cb\u003eOther NSAIDs:\u003c\/b\u003e the use of Nurofen Fever and Pain should be avoided concomitantly with NSAIDs, including selective COX-2 inhibitors. Analgesics, antipyretics, non-steroidal anti-inflammatories can cause potentially serious hypersensitivity reactions (anaphylactoid reactions), even in subjects not previously exposed to this type of drugs. The risk of hypersensitivity reactions after taking ibuprofen is greater in subjects who have experienced such reactions after the use of other analgesics, antipyretics, non-steroidal anti-inflammatory drugs and in subjects with bronchial hyperreactivity (asthma), hay fever, nasal polyposis, chronic obstructive respiratory diseases or previous episodes of angioedema (see section 4.2 and section 4.8). \u003cb\u003eGastrointestinal (GI) effects:\u003c\/b\u003e Gastrointestinal hemorrhage, ulceration and perforation: Gastrointestinal hemorrhage, ulceration and perforation, which may be fatal, have been reported during treatment with all NSAIDs, at any time, with or without warning symptoms or previous history of serious gastrointestinal events. Elderly: Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which may be fatal (see section 4.2). In the elderly and in patients with a history of ulcer, especially if complicated by haemorrhage or perforation (see section 4.3), the risk of gastrointestinal haemorrhage, ulceration or perforation is higher with increased doses of NSAIDs. These patients should start treatment with the lowest available dose. The concomitant use of protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients and also for patients taking low doses of aspirin or other drugs that may increase the risk of gastrointestinal events (see section 4.5). Patients with a history of gastrointestinal toxicity, particularly the elderly, should report any unusual gastrointestinal symptoms (especially gastrointestinal haemorrhage) particularly in the initial stages of treatment. Caution should be exercised in patients taking concomitant medications that may increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or antiplatelet agents such as acetylsalicylic acid (aspirin) (see section 4.5). When gastrointestinal bleeding or ulceration occurs in patients taking Nurofen Fever and Pain, treatment should be discontinued. NSAIDs should be administered with caution to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated (see section 4.8). \u003cb\u003eDermatological effects: \u003c\/b\u003esevere skin reactions: serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported rarely in association with the use of NSAIDs (see section 4.8). Patients appear to be at higher risk in the early stages of therapy: the onset of the reaction occurs in most cases within the first month of treatment. Acute generalized exanthematous pustulosis (PEAG) has been reported in connection with ibuprofen-containing medicinal products. Ibuprofen should be discontinued at the first appearance of signs and symptoms of severe skin reactions, such as rash, mucosal lesions or any other sign of hypersensitivity. Masking of symptoms of underlying infections: Nurofen Fever and Pain may mask the symptoms of infection, which may delay the initiation of appropriate treatment and therefore worsen the outcome of the infection. This has been observed in community-acquired bacterial pneumonia and bacterial complications of chickenpox. When Nurofen Fever and Pain is administered for the relief of infection-related fever or pain, monitoring of the infection is advised. In non-hospital settings, the patient should seek medical attention if symptoms persist or worsen. Chickenpox can exceptionally cause serious infectious complications to the skin and soft tissues. To date, the contribution of NSAIDs in the worsening of these infections cannot be excluded, therefore it is advisable to avoid the use of Nurofen Fever and Pain in case of chickenpox. \u003cb\u003eCardiovascular and cerebrovascular effects\u003c\/b\u003e: caution is required (discuss with your doctor or pharmacist) before starting treatment in patients with a positive history of hypertension and\/or heart failure since fluid retention, hypertension and edema have been reported in association with treatment with NSAIDs. Clinical studies and epidemiological data suggest that the use of ibuprofen, especially at high doses (2400 mg\/day) and for long-term treatments, may be associated with a modest increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke). In general, epidemiological studies do not suggest that low doses of ibuprofen (e.g. ≤ 1200 mg\/day) are associated with an increased risk of myocardial infarction. Patients with uncontrolled hypertension, congestive heart failure, established ischemic heart disease, peripheral arterial disease, and\/or cerebrovascular disease should be treated with ibuprofen only after careful consideration. Similar considerations must be made before starting long-term treatment in patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidemia, diabetes mellitus, smoking). \u003cb\u003eRenal disorders\u003c\/b\u003e: in general, the habitual use of analgesics, especially the combination of different analgesic substances, can cause permanent kidney damage, with risk of renal failure (analgesic nephropathy). In dehydrated children and adolescents there is a risk of impaired renal function (see sections 4.3 and 4.8). In patients with heart failure, renal or hepatic failure, in those taking diuretics or who have undergone major surgery resulting in dehydration, monitoring of urine output and renal function should be considered. Other considerations: Prolonged use of any type of pain reliever for headaches can make symptoms worse. If this situation occurs or is suspected, the doctor should be consulted and treatment should be suspended. The diagnosis of medication overuse headache (MOH) should be suspected in patients who experience frequent or daily headaches despite or because of regular use of headache medications \u003cb\u003eCompromised female fertility\u003c\/b\u003e: see paragraph 4.6. The use of ibuprofen, acetylsalicylic acid or other analgesics, antipyretics, non-steroidal anti-inflammatories requires particular caution: • in case of current or previous asthma or allergic diseases: possible deterioration of bronchoconstriction; in the presence of coagulation defects as ibuprofen, the active ingredient of Nurofen Fever and Pain, can temporarily inhibit the function of platelets (thrombocyte aggregation). It is therefore recommended to carefully monitor patients with coagulation disorders; • in the presence of kidney disease, heart disease or hypertension: possible critical reduction in renal function (especially in subjects with impaired renal or hepatic function, heart failure or being treated with diuretics), nephrotoxicity or fluid retention; • in the presence of liver disease: possible hepatotoxicity; • rehydrate the subject before starting and during treatment in case of dehydration (for example due to fever, vomiting or diarrhea); • immediately after major surgery; • congenital disorders of porphyrin metabolism (for example, acute intermittent porphyria). The following precautions become relevant during prolonged treatments: • monitor for signs or symptoms of gastrointestinal ulceration or bleeding; • monitor for signs or symptoms of hepatotoxicity; • monitor for signs or symptoms of nephrotoxicity; • if visual disturbances occur (blurred or reduced vision, scotomas, alteration of color perception): stop treatment and consult your ophthalmologist; • if signs or symptoms of meningitis arise: evaluate the rare possibility that it is due to the use of ibuprofen (aseptic meningitis; more frequent in subjects suffering from systemic lupus erythematosus and mixed connective tissue disease or other collagenopathies) (see section 4.8). Since Nurofen Fever and Pain contains \u003cb\u003eliquid maltitol\u003c\/b\u003e, patients with rare hereditary problems of fructose intolerance should not take this medicine. May have a mild laxative effect. The caloric value of maltitol is 2.3 kcal\/g. Nurofen Fever and Pain does not contain sugar and is therefore indicated for those patients who need to control their intake of sugars and calories. This medicine contains 9.08 mg of \u003cb\u003esodium\u003c\/b\u003e per 5 ml equivalent to 0.45% of the WHO recommended maximum daily intake which corresponds to 2 g of sodium for an adult. NUROFEN FEVER AND PAIN Children 100mg\/5ml oral suspension strawberry flavor without sugar contains 11.75 mg of \u003cb\u003epropylene glycol\u003c\/b\u003e (present in the strawberry flavour) in 5 ml. Coadministration with any alcohol dehydrogenase substrate such as ethanol may induce serious adverse effects in neonates. NUROFEN FEVER AND PAIN Children 100mg\/5ml sugar-free orange flavor oral suspension contains only a very small quantity of gluten (from\u003cb\u003ewheat starch\u003c\/b\u003e present in the orange flavour). This medicine is considered (gluten-free) and is very unlikely to cause problems for a celiac patient. A 5 ml dose contains no more than 0.225 micrograms of gluten. If the patient is allergic to wheat (condition other than celiac disease) he should not take this medicine.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eINTERACTIONS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cb\u003eIbuprofen should be avoided in association with\u003c\/b\u003e: • Acetylsalicylic acid: Concomitant administration of ibuprofen and acetylsalicylic acid is generally not recommended due to the potential for increased side effects. Experimental data indicate that ibuprofen can inhibit the effects of low-dose acetylsalicylic acid on platelet aggregation when the drugs are administered concomitantly. However, the paucity of data and the uncertainties relating to the application of data extrapolated ex vivo to the clinical situation do not allow definitive conclusions to be drawn on the regular use of ibuprofen; Clinically relevant effects resulting from occasional use of ibuprofen are unlikely (see section 5.1). • \u003cb\u003eOther NSAIDs including selective cyclooxygenase-2 inhibitors\u003c\/b\u003e: avoid the simultaneous use of two or more analgesics, antipyretics, non-steroidal anti-inflammatory drugs: increased risk of side effects (see section 4.4). \u003cb\u003eIbuprofen should be used with caution in combination with:\u003c\/b\u003e • corticosteroids: increased risk of gastrointestinal ulceration or haemorrhage (see section 4.4); • quinolone antibiotics: data from animal studies indicate that NSAIDs may increase the risk of seizures associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may have an increased risk of developing seizures; • anticoagulants, such as warfarin: NSAIDs can increase the effects of anticoagulants (see section 4.4); • antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding (see section 4.4); • phenytoin: Concomitant use of Nurofen Fever and Pain with phenytoin may increase serum levels of these medicines. Correct use of the drugs (administered for a maximum period of 3 days) does not normally require monitoring of serum phenytoin levels. • antidiabetics: an increase in the hypoglycaemic effect of sulfonylureas is possible. In the case of simultaneous treatment, monitoring of blood glucose levels is recommended. • antivirals, such as ritonavir: possible increase in the concentration of NSAIDs; • ciclosporin: increased risk of nephrotoxicity; • mifepristone: NSAIDs must not be administered in the 8-12 days following taking mifepristone as they can reduce its effectiveness; • cytotoxics, such as methotrexate: reduction of excretion (increased risk of toxicity); • lithium: reduction of excretion (increased risk of toxicity); • tacrolimus: increased risk of nephrotoxicity; • uricosurics, such as probenecid and sulfinpyrazone: slow the excretion of NSAIDs (increase in plasma concentrations); • methotrexate: potential increase in plasma concentrations of methotrexate; • zidovudine: increased risk of blood toxicity when NSAIDs are used in combination with zidovudine. There are demonstrations of increased risk of haemarthrosis and hematomas in HIV (+) haemophiliacs if treated simultaneously with zidovudine and ibuprofen; • anti-hypertensives, (ACE inhibitors and angiotensin II antagonists) and diuretics: NSAIDs can reduce the effect of diuretics and other antihypertensive drugs. In some patients with compromised renal function (e.g. dehydrated patients or elderly patients with compromised renal function) co-administration of an ACE inhibitor or an angiotensin II antagonist and agents that inhibit the cyclo-oxygenase system may lead to further deterioration of renal function, including possible acute renal failure, which is usually reversible. These interactions should be considered in patients taking Nurofen Fever and Pain concomitantly with ACE inhibitors or angiotensin II antagonists. Therefore, the combination should be administered with caution, especially in elderly patients. Patients should be adequately hydrated and consideration should be given to monitoring renal function after initiation of concomitant therapy and periodically. • potassium-sparing diuretics: concomitant administration of Nurofen Fever and Pain and potassium-sparing diuretics may lead to hyperkalaemia • CYP2C9 inhibitors: Concomitant administration of ibuprofen and CYP2C9 inhibitors may increase exposure to ibuprofen (CYP2C9 substrate). In a study with voriconazole and fluconazole (CYP2C9 inhibitors), an increased exposure to S(+)-ibuprofen by approximately 80% to 100% was demonstrated. Reduction of the ibuprofen dose should be considered when strong CYP2C9 inhibitors are coadministered, particularly when high doses of ibuprofen are administered with voriconazole or fluconazole. • cardiac glycosides (Digoxin): NSAIDs can worsen heart failure, reduce VGF (glomerular filtration rate) and increase plasma glycoside levels.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eSIDE EFFECTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eThe list of the following side effects includes all those that have been recognized during treatment with ibuprofen for short periods of treatment and for daily doses up to a maximum of 1200 mg. In the case of high-dose therapies for chronic or prolonged pathologies, other undesirable effects may occur. Adverse reactions associated with the administration of ibuprofen are listed below according to system organ class and frequency. Frequencies are defined as: Very common (≥1\/10); Common (≥1\/100, \u003c1\/10); Uncommon (≥1\/1,000, \u003c1\/100); Rare (≥1\/10,000, \u003c1\/1,000) ; Very rare (\u003c1\/10,000); Not known (frequency cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.\u003c\/p\u003e\n\u003cp\u003eInfections and infestations - Frequency: Rare. Adverse reaction: Cystitis, rhinitis.\u003c\/p\u003e\n\u003cp\u003eInfections and infestations - Frequency: Very rare. Adverse reaction: Worsening of infection-related inflammation (e.g. development of necrotizing fasciitis), in exceptional cases severe skin infections and soft tissue complications have been reported during a chickenpox infection.\u003c\/p\u003e\n\u003cp\u003eBlood and lymphatic system disorders - Frequency: Very rare. Adverse reaction: Hematopoiesis disorders ¹\u003c\/p\u003e\n\u003cp\u003eImmune system disorders - Frequency: Uncommon. Adverse reaction: Hypersensitivity reactions manifested by urticaria and pruritus²\u003c\/p\u003e\n\u003cp\u003eImmune system disorders - Frequency: Very rare. Adverse reaction: Severe hypersensitivity reactions including swelling of the face, tongue and larynx, dyspnoea, tachycardia, hypotension (anaphylaxis, angioedema or severe shock). Asthma exacerbation.\u003c\/p\u003e\n\u003cp\u003eMetabolism and nutrition disorders - Frequency: Not known. Adverse reaction: Fluid retention and decreased appetite³.\u003c\/p\u003e\n\u003cp\u003ePsychiatric disorders - Frequency: Not known. Adverse reaction: Irritability\u003c\/p\u003e\n\u003cp\u003ePsychiatric disorders - Frequency: Rare. Adverse reaction: Depression, insomnia, difficulty concentrating, emotional lability, hearing disorders.\u003c\/p\u003e\n\u003cp\u003eNervous system disorders - Frequency: Uncommon. Adverse reaction: Headache, dizziness, drowsiness, convulsions, agitation, tiredness.\u003c\/p\u003e\n\u003cp\u003eNervous system disorders - Frequency: Very rare. Adverse reaction: Aseptic meningitis4.\u003c\/p\u003e\n\u003cp\u003eNervous system disorders - Frequency: Rare. Adverse reaction: Cerebrovascular haemorrhage.\u003c\/p\u003e\n\u003cp\u003eEye disorders - Frequency: Rare. Adverse reaction: Dry eyes.\u003c\/p\u003e\n\u003cp\u003eEye disorders - Frequency: Uncommon. Adverse reaction: Visual disturbances.\u003c\/p\u003e\n\u003cp\u003eEar and labyrinth disorders - Frequency: Not known. Adverse reaction: Tinnitus.\u003c\/p\u003e\n\u003cp\u003eCardiac disorders - Frequency: Very rare. Adverse reaction: Myocardial infarction.\u003c\/p\u003e\n\u003cp\u003eCardiac disorders - Frequency: Not known. Adverse reaction: Heart failure and edema5.\u003c\/p\u003e\n\u003cp\u003eCardiac disorders - Frequency: Rare. Adverse reaction: Palpitations.\u003c\/p\u003e\n\u003cp\u003eVascular disorders - Frequency: Not known. Adverse reaction: Hypertension5 and shock.\u003c\/p\u003e\n\u003cp\u003eRespiratory, thoracic and mediastinal disorders - Frequency: Not known. Adverse reaction: Respiratory tract reactivity including asthma, laryngeal obstruction, bronchospasm or apnea, dyspnea.\u003c\/p\u003e\n\u003cp\u003eGastrointestinal disorders - Frequency: Uncommon. Adverse reaction: Abdominal pain, nausea and dyspepsia6.\u003c\/p\u003e\n\u003cp\u003eGastrointestinal disorders - Frequency: Rare. Adverse reaction: Diarrhoea, flatulence, dry mouth, constipation and vomiting.\u003c\/p\u003e\n\u003cp\u003eGastrointestinal disorders - Frequency: Very rare. Adverse reaction: Peptic ulcer, gastrointestinal perforation or bleeding, melena and haematemesis7. Mouth ulcerations and gastritis.\u003c\/p\u003e\n\u003cp\u003eGastrointestinal disorders - Frequency: Not known. Adverse reaction: Exacerbation of colitis and Crohn's disease8, pancreatitis, duodenitis, esophagitis.\u003c\/p\u003e\n\u003cp\u003eHepatobiliary disorders - Frequency: Very rare. Adverse reaction: Liver dysfunction, hepatitis, jaundice, hepatorenal syndrome, hepatic necrosis, hepatic failure.\u003c\/p\u003e\n\u003cp\u003eSkin and subcutaneous tissue disorders - Frequency: Uncommon. Adverse reaction: Various skin rashes²\u003c\/p\u003e\n\u003cp\u003eSkin and subcutaneous tissue disorders - Frequency: Very rare. Adverse reaction: Bullous reactions including Stevens-Johnson syndrome, erythema multiforme and toxic epidermal necrolysis².\u003c\/p\u003e\n\u003cp\u003eSkin and subcutaneous tissue disorders - Frequency: Rare. Adverse reaction: Exfoliative dermatitis, alopecia, photosensitivity reactions.\u003c\/p\u003e\n\u003cp\u003eSkin and subcutaneous tissue disorders - Frequency: Not known. Adverse reaction: Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), acute generalized exanthematous pustulosis (PEAG).\u003c\/p\u003e\n\u003cp\u003eRenal and urinary disorders - Frequency: Rare. Adverse reaction: Tubular necrosis, glomerular nephritis, polyuria, hematuria.\u003c\/p\u003e\n\u003cp\u003eRenal and urinary disorders - Frequency: Very rare. Adverse reaction: Acute renal failure9.\u003c\/p\u003e\n\u003cp\u003eDiagnostic tests - Frequency: Rare. Adverse reaction: Decreased hematocrit levels.\u003c\/p\u003e\n\u003cp\u003eDiagnostic tests - Frequency: Very rare. Adverse reaction: Decreased hemoglobin levels.\u003c\/p\u003e\n\u003cp\u003e\u003cb\u003eDescription of some adverse reactions\u003c\/b\u003e \u003csup\u003e1\u003c\/sup\u003e Hematopoiesis disorders including anemia, aplastic anemia, hemolytic anemia (positive Coombs test), leukopenia, neutropenia, thrombocytopenia (with or without purpura), eosinophilia, pancytopenia, and agranulocytosis. The first symptoms may be: fever, sore throat, superficial mouth ulcers, flu-like symptoms, marked fatigue, nosebleeds and bleeding. In these cases the patient should be advised to stop taking the medicine immediately, to avoid any self-medication medicine containing analgesics or antipyretics and to consult his doctor. Rarely congestive heart failure in patients with impaired cardiac function. ² Hypersensitivity reactions: these reactions include a) non-specific allergic reactions and anaphylaxis, fever, chills, b) respiratory tract reactivity including asthma, aggravated asthma, bronchospasm (see section 4.3 and 4.4) or dyspnoea or c) various skin conditions including various skin rashes (including maculopapular in nature), pruritus, urticaria with or without angioedema, purpura, angioedema and much rarely, bullous and exfoliative dermatitis including toxic epidermal necrolysis, Stevens-Johnson syndrome and erythema multiforme. ³ Decreased appetite: generally resolves rapidly upon discontinuation of treatment (see section 4.4). \u003csup\u003e4\u003c\/sup\u003e The pathogenetic mechanism of drug-induced aseptic meningitis is not completely known. However, the data available on aseptic meningitis related to the administration of NSAIDs leads us to think of an immune reaction (due to a temporal relationship with the intake of the medicine and the disappearance of symptoms after discontinuation of treatment). Of note, individual cases of symptoms of aseptic meningitis (such as stiff neck, neck numbness, headache, nausea, vomiting, fever and disorientation) have been observed during treatment with ibuprofen in patients with autoimmune diseases (such as systemic lupus erythromatosus, mixed connective tissue disease).\u003csup\u003e5\u003c\/sup\u003e Heart failure and edema: Clinical studies and epidemiological data suggest that the use of ibuprofen, especially at high doses (2400 mg\/day) and for long-term treatments, may be associated with a modest increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke) (see section 4.4). Congestive heart failure in patients with impaired cardiac function. \u003csup\u003e6\u003c\/sup\u003e The most commonly observed adverse events are gastrointestinal in nature. Gastric discomfort can be reduced by taking the medicine on a full stomach. \u003csup\u003e7\u003c\/sup\u003e Peptic ulcers, gastrointestinal perforation or hemorrhage, melena, and sometimes fatal hematemesis may occur. \u003csup\u003e8\u003c\/sup\u003e Exacerbation of colitis and Crohn's disease (see section 4.4). \u003csup\u003e9\u003c\/sup\u003e Acute renal failure especially in case of long-term therapy, associated with increased serum urea levels and edema. Papillary necrosis may occur. \u003cb\u003eReporting of suspected adverse reactions\u003c\/b\u003e Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit\/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at: https:\/\/www.aifa.gov.it\/content\/segnalazioni-reazioniavverse\u003ci\u003e. \u003c\/i\u003e\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eOVERDOSE\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cu\u003eToxicity \u003c\/u\u003e Signs and symptoms of toxicity were generally not observed at doses below 100 mg\/kg in children or adults. However, in some cases supportive treatment may be necessary. Children have been observed to exhibit signs and symptoms of toxicity after ingesting ibuprofen at doses of 400 mg\/kg or greater. The half-life of the drug in case of overdose is 1.5-3 hours. \u003cu\u003eSymptoms \u003c\/u\u003e Most patients who accidentally ingest clinically relevant quantities of ibuprofen will experience symptoms within 4 to 6 hours. The most commonly reported overdose symptoms include: nausea, vomiting, abdominal pain, lethargy, and drowsiness. Central nervous system (CNS) effects include headache, tinnitus, dizziness, seizures, and loss of consciousness. Nystagmus, metabolic acidosis, hypothermia, renal effects, gastrointestinal bleeding, coma, apnea, diarrhea and CNS and respiratory depression have also been reported rarely. Disorientation, arousal, fainting and cardiovascular toxicity including hypotension, bradycardia and tachycardia have been reported. In cases of significant overdose, renal failure and liver damage are possible. In cases of severe poisoning, metabolic acidosis and a prolongation of the prothrombin time (INR) may occur, probably caused by interference with the action of coagulation factors present in the circulation. In asthmatic subjects, an exacerbation of the symptoms of the disease may occur. \u003cu\u003eTreatment \u003c\/u\u003e There is no specific antidote for ibuprofen overdose. In case of overdose, symptomatic and supportive treatment is therefore indicated and must include maintaining a patent airway and monitoring cardiac function and vital signs until the patient is stabilised. Particular attention is due to the control of blood pressure, acid-base balance and any gastrointestinal bleeding. Administration of activated charcoal should be considered within one hour of ingesting a potentially toxic quantity. Alternatively, in adults, gastric lavage should be considered within one hour of ingestion of a potentially life-threatening overdose. Adequate diuresis must be ensured and renal and hepatic functions must be closely monitored. The patient must remain under observation for at least four hours following ingestion of a potentially toxic amount of drug. Any occurrence of frequent or prolonged convulsions should be treated with intravenous diazepam or lorazepam. If ibuprofen has already been absorbed, alkaline substances should be administered to promote excretion of the acidic ibuprofen in the urine. Administer bronchodilators in case of asthma. Depending on the patient's clinical condition, other support measures may be necessary. For more information, contact your local poison control center.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003ePREGNANCY AND BREASTFEEDING\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eChildren under the age of 12 are unlikely to become pregnant or breastfeed. Furthermore, in such circumstances the following considerations must be kept in mind. \u003cu\u003ePregnancy \u003c\/u\u003e Inhibition of prostaglandin synthesis can negatively affect pregnancy and\/or embryo\/foetal development. Results of epidemiological studies suggest an increased risk of miscarriage and cardiac malformation and gastroschisis after the use of a prostaglandin synthesis inhibitor in the early stages of pregnancy. The absolute risk of cardiac malformations increased from less than 1% to approximately 1.5%. The risk has been thought to increase with dose and duration of therapy. In animals, the administration of prostaglandin synthesis inhibitors has been shown to cause an increase in pre- and post-implantation loss and embryo-foetal mortality. Furthermore, an increased incidence of various malformations, including cardiovascular malformations, has been reported in animals administered prostaglandin synthesis inhibitors during the organogenetic period. From the 20th\u003csup\u003ea\u003c\/sup\u003e week of pregnancy onwards, the use of ibuprofen could cause oligohydramnios resulting from fetal renal dysfunction. This condition may be experienced shortly after starting treatment and is usually reversible upon discontinuation of treatment. Additionally, cases of constriction of the ductus arteriosus have been reported following treatment in the second trimester, most of which resolved after treatment was discontinued. Therefore, during the first and second trimester of pregnancy ibuprofen should not be administered unless strictly necessary. If ibuprofen is used by a woman planning pregnancy, or during the first and second trimester of pregnancy, the lowest possible dose should be used for the shortest possible time. Following exposure to ibuprofen for several days from the 20th\u003csup\u003ea\u003c\/sup\u003e week of gestation onwards, antenatal monitoring for oligohydramnios and ductus arteriosus constriction should be considered. In case of oligohydramnios or constriction of the ductus arteriosus, treatment with ibuprofen should be discontinued. During the third trimester of pregnancy, all inhibitors of prostaglandin synthesis can expose the fetus to: - cardiopulmonary toxicity (premature constriction\/closure of the ductus arteriosus and pulmonary hypertension); - renal dysfunction (see above); the mother and the newborn, at the end of pregnancy, to: - possible prolongation of bleeding time, an anti-aggregating effect which can occur even at very low doses; - inhibition of uterine contractions resulting in delayed or prolonged labor. Consequently, Nurofen Fever and Pain is contraindicated during the third trimester of pregnancy (see sections 4.3 and 5.3). \u003cu\u003eBreastfeeding \u003c\/u\u003e There is limited data showing that ibuprofen can pass in low concentrations into breast milk and is unlikely to have any adverse effects on newborns.\u003cu\u003eFertility \u003c\/u\u003e There is evidence that medicinal products that inhibit cyclooxygenase\/prostaglandin synthesis may cause impairment of female fertility by affecting ovulation. This effect is reversible after discontinuation of treatment.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eEFFECTS ON DRIVING ABILITY\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eNot relevant, considering the age of the patient.\u003c\/p\u003e","brand":"Reckitt Benckiser","offers":[{"title":"Default Title","offer_id":51730202722631,"sku":"034102020","price":13.3,"currency_code":"EUR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0564\/4989\/2467\/files\/reckitt-benckiser-h-it-spa-nurofen-febbre-e-dolore-bambini-100-mg-5-ml-150-ml-sospensione-senza-zucchero-gusto-arancia-con-siringa-farmacia-dottor-tili-1213791445.jpg?v=1767138210"},{"product_id":"nurofen-febbre-e-dolore-bambini-100-mg-5-ml-150-ml-sospensione-orale-senza-zucchero-gusto-fragola","title":"Nurofen fever and pain children 100 mg\/5 ml 150 ml sugar-free oral suspension strawberry flavour","description":"\u003cp\u003e\u003cstrong\u003eINDICATIONS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eSymptomatic treatment of fever, including post-vaccination fever, and mild or moderate pain (such as headache, toothache, sore throat, earache).\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eACTIVE INGREDIENTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eNUROFEN FEVER AND PAIN Children 100mg\/5ml Oral Suspension Each ml of oral suspension contains: Active ingredient: ibuprofen 20 mg. Excipients with known effects: liquid maltitol, propylene glycol (present in the strawberry flavour), wheat starch (present in the orange flavour) and sodium. For the full list of excipients, see section 6.1.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eEXCIPIENTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cu\u003eNurofen Fever and Pain Children 100mg\/5ml oral suspension orange flavor without sugar\u003c\/u\u003e Polysorbate 80, glycerin, maltitol syrup, sodium saccharin, citric acid, sodium citrate, xanthan gum, sodium chloride, orange flavor, domiphene bromide, purified water. \u003cu\u003eNurofen Fever and Pain Children 100mg\/5ml oral suspension strawberry flavor without sugar\u003c\/u\u003e Polysorbate 80, glycerin, maltitol syrup, sodium saccharin, citric acid, sodium citrate, xanthan gum, sodium chloride, strawberry flavor, domiphene bromide, purified water.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eCONTRAINDICATIONS AND SIDE EFFECTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e• Hypersensitivity to ibuprofen or to any of the excipients listed in section 6.1. • Children younger than 3 months or weighing less than 5.6 kg. • The medicine is contraindicated in patients who show or have previously shown hypersensitivity (e.g. asthma, rhinitis, angioedema or urticaria) to acetylsalicylic acid or other analgesics, antipyretics, non-steroidal anti-inflammatory drugs (NSAIDs), in particular when hypersensitivity is associated with nasal polyposis and asthma. • Active peptic ulcer. • Severe renal or hepatic impairment (see section 4.4). • Severe heart failure (see section 4.4). • History of gastrointestinal hemorrhage or perforation, related to previous NSAID-based therapy. History of recurrent hemorrhage\/peptic ulcer (two or more distinct episodes of demonstrated ulceration or bleeding). • Concomitant use of NSAIDs, including specific COX-2 inhibitors. • Patients with a history of cerebrovascular bleeding or other active bleeding. • Patients with unclear blood formation disorders. • Patients with severe dehydration (caused by vomiting, diarrhea or insufficient fluid intake). • During the last trimester of pregnancy (see section 4.6).\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eDOSAGE\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cu\u003eDosage \u003c\/u\u003e The daily dose is structured based on the weight and age of the patient. Undesirable effects can be minimized by using the lowest effective dose for the shortest possible treatment duration needed to control symptoms (see section 4.4). In children aged between 3 and 6 months, limit administration to those weighing more than 5.6 kg. \u003cu\u003eMethod of administration \u003c\/u\u003e Oral administration to infants and children aged between 3 months and 12 years should take place using the measuring syringe or measuring spoon supplied with the product. Patients suffering from stomach problems can take the medicine with meals. The daily dose of 20-30 mg\/kg of body weight, divided 3 times a day at 6-8 hour intervals, can be administered based on the following schedule (do not exceed the recommended doses). The graduated scale on the body of the syringe highlights the notches for the different dosages; in particular the 2.5 ml mark corresponding to 50 mg of ibuprofen and the 5 ml mark corresponding to 100 mg of ibuprofen. The measuring spoon has two marks for two different doses: the 2.5 ml mark corresponding to 50 mg of ibuprofen and the 5 ml mark corresponding to 100 mg of ibuprofen.\u003c\/p\u003e\n\u003cp\u003eWeight: From 5.6 kg - Approximate age: 3 - 6 months. Single dose in ml: 2.5 ml. maximum number of administrations\/day: 3 in 24 hours.\u003c\/p\u003e\n\u003cp\u003eWeight: From 7 Kg - Approximate age: 6 - 12 months. Single dose in ml: 2.5 ml. maximum number of administrations\/day: 3 in 24 hours.\u003c\/p\u003e\n\u003cp\u003eWeight: From 10 Kg - Approximate age: 1 - 3 years. Single dose in ml: 5 ml. maximum number of administrations\/day: 3 in 24 hours.\u003c\/p\u003e\n\u003cp\u003eWeight: From 15 Kg - Approximate age: 4 - 6 years. Single dose in ml: 7.5 ml (5 ml + 2.5 ml). maximum number of administrations\/day: 3 in 24 hours.\u003c\/p\u003e\n\u003cp\u003eWeight: From 20 kg - Approximate age: 7 - 9 years. Single dose in ml: 10 ml. maximum number of administrations\/day: 3 in 24 hours.\u003c\/p\u003e\n\u003cp\u003eWeight: From 28 to 43 Kg - Approximate age: 10 - 12 years. Single dose in ml: 15 ml. maximum number of administrations\/day: 3 in 24 hours.\u003c\/p\u003e\n\u003cp\u003eIn the case of post-vaccination fever, refer to the daily dosage recommended in the table above. The product is intended for short-term treatments. In infants aged between 3 and 5 months, the doctor should be consulted if symptoms persist for more than 24 hours or in the case of worsening of symptoms. If the use of the medicine is necessary for more than 3 days in infants and children over 6 months of age and in adolescents, or in the case of worsening of symptoms, a doctor should be consulted. \u003cu\u003eInstructions for using the dosing syringe\u003c\/u\u003e: 1. Unscrew the cap by pushing it downwards and turning it to the left. 2. Insert the tip of the syringe fully into the hole in the undercap. 3. Shake well. 4. Turn the bottle upside down, then, holding the syringe firmly, gently pull the plunger downwards, allowing the suspension to flow into the syringe up to the mark corresponding to the desired dose. 5. Place the bottle back upright and remove the syringe by gently rotating it. 6. Introduce the tip of the syringe into the child's mouth, and apply slight pressure on the plunger to let the suspension flow out. 7. After use, screw the cap to close the bottle and wash the syringe with hot water. Leave it to dry, keeping it out of the reach and sight of children.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eCONSERVATION\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eNo details.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eWARNINGS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eSide effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see paragraphs below on gastrointestinal and cardiovascular risks). \u003cb\u003eOther NSAIDs:\u003c\/b\u003e the use of Nurofen Fever and Pain should be avoided concomitantly with NSAIDs, including selective COX-2 inhibitors. Analgesics, antipyretics, non-steroidal anti-inflammatories can cause potentially serious hypersensitivity reactions (anaphylactoid reactions), even in subjects not previously exposed to this type of drugs. The risk of hypersensitivity reactions after taking ibuprofen is greater in subjects who have experienced such reactions after the use of other analgesics, antipyretics, non-steroidal anti-inflammatory drugs and in subjects with bronchial hyperreactivity (asthma), hay fever, nasal polyposis, chronic obstructive respiratory diseases or previous episodes of angioedema (see section 4.2 and section 4.8). \u003cb\u003eGastrointestinal (GI) effects:\u003c\/b\u003e Gastrointestinal hemorrhage, ulceration and perforation: Gastrointestinal hemorrhage, ulceration and perforation, which may be fatal, have been reported during treatment with all NSAIDs, at any time, with or without warning symptoms or previous history of serious gastrointestinal events. Elderly: Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which may be fatal (see section 4.2). In the elderly and in patients with a history of ulcer, especially if complicated by haemorrhage or perforation (see section 4.3), the risk of gastrointestinal haemorrhage, ulceration or perforation is higher with increased doses of NSAIDs. These patients should start treatment with the lowest available dose. The concomitant use of protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients and also for patients taking low doses of aspirin or other drugs that may increase the risk of gastrointestinal events (see section 4.5). Patients with a history of gastrointestinal toxicity, particularly the elderly, should report any unusual gastrointestinal symptoms (especially gastrointestinal haemorrhage) particularly in the initial stages of treatment. Caution should be exercised in patients taking concomitant medications that may increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or antiplatelet agents such as acetylsalicylic acid (aspirin) (see section 4.5). When gastrointestinal bleeding or ulceration occurs in patients taking Nurofen Fever and Pain, treatment should be discontinued. NSAIDs should be administered with caution to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated (see section 4.8). \u003cb\u003eDermatological effects: \u003c\/b\u003esevere skin reactions: serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported rarely in association with the use of NSAIDs (see section 4.8). Patients appear to be at higher risk in the early stages of therapy: the onset of the reaction occurs in most cases within the first month of treatment. Acute generalized exanthematous pustulosis (PEAG) has been reported in connection with ibuprofen-containing medicinal products. Ibuprofen should be discontinued at the first appearance of signs and symptoms of severe skin reactions, such as rash, mucosal lesions or any other sign of hypersensitivity. Masking of symptoms of underlying infections: Nurofen Fever and Pain may mask the symptoms of infection, which may delay the initiation of appropriate treatment and therefore worsen the outcome of the infection. This has been observed in community-acquired bacterial pneumonia and bacterial complications of chickenpox. When Nurofen Fever and Pain is administered for the relief of infection-related fever or pain, monitoring of the infection is advised. In non-hospital settings, the patient should seek medical attention if symptoms persist or worsen. Chickenpox can exceptionally cause serious infectious complications to the skin and soft tissues. To date, the contribution of NSAIDs in the worsening of these infections cannot be excluded, therefore it is advisable to avoid the use of Nurofen Fever and Pain in case of chickenpox. \u003cb\u003eCardiovascular and cerebrovascular effects\u003c\/b\u003e: caution is required (discuss with your doctor or pharmacist) before starting treatment in patients with a positive history of hypertension and\/or heart failure since fluid retention, hypertension and edema have been reported in association with treatment with NSAIDs. Clinical studies and epidemiological data suggest that the use of ibuprofen, especially at high doses (2400 mg\/day) and for long-term treatments, may be associated with a modest increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke). In general, epidemiological studies do not suggest that low doses of ibuprofen (e.g. ≤ 1200 mg\/day) are associated with an increased risk of myocardial infarction. Patients with uncontrolled hypertension, congestive heart failure, established ischemic heart disease, peripheral arterial disease, and\/or cerebrovascular disease should be treated with ibuprofen only after careful consideration. Similar considerations must be made before starting long-term treatment in patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidemia, diabetes mellitus, smoking). \u003cb\u003eRenal disorders\u003c\/b\u003e: in general, the habitual use of analgesics, especially the combination of different analgesic substances, can cause permanent kidney damage, with risk of renal failure (analgesic nephropathy). In dehydrated children and adolescents there is a risk of impaired renal function (see sections 4.3 and 4.8). In patients with heart failure, renal or hepatic failure, in those taking diuretics or who have undergone major surgery resulting in dehydration, monitoring of urine output and renal function should be considered. Other considerations: Prolonged use of any type of pain reliever for headaches can make symptoms worse. If this situation occurs or is suspected, the doctor should be consulted and treatment should be suspended. The diagnosis of medication overuse headache (MOH) should be suspected in patients who experience frequent or daily headaches despite or because of regular use of headache medications \u003cb\u003eCompromised female fertility\u003c\/b\u003e: see paragraph 4.6. The use of ibuprofen, acetylsalicylic acid or other analgesics, antipyretics, non-steroidal anti-inflammatories requires particular caution: • in case of current or previous asthma or allergic diseases: possible deterioration of bronchoconstriction; in the presence of coagulation defects as ibuprofen, the active ingredient of Nurofen Fever and Pain, can temporarily inhibit the function of platelets (thrombocyte aggregation). It is therefore recommended to carefully monitor patients with coagulation disorders; • in the presence of kidney disease, heart disease or hypertension: possible critical reduction in renal function (especially in subjects with impaired renal or hepatic function, heart failure or being treated with diuretics), nephrotoxicity or fluid retention; • in the presence of liver disease: possible hepatotoxicity; • rehydrate the subject before starting and during treatment in case of dehydration (for example due to fever, vomiting or diarrhea); • immediately after major surgery; • congenital disorders of porphyrin metabolism (for example, acute intermittent porphyria). The following precautions become relevant during prolonged treatments: • monitor for signs or symptoms of gastrointestinal ulceration or bleeding; • monitor for signs or symptoms of hepatotoxicity; • monitor for signs or symptoms of nephrotoxicity; • if visual disturbances occur (blurred or reduced vision, scotomas, alteration of color perception): stop treatment and consult your ophthalmologist; • if signs or symptoms of meningitis arise: evaluate the rare possibility that it is due to the use of ibuprofen (aseptic meningitis; more frequent in subjects suffering from systemic lupus erythematosus and mixed connective tissue disease or other collagenopathies) (see section 4.8). Since Nurofen Fever and Pain contains \u003cb\u003eliquid maltitol\u003c\/b\u003e, patients with rare hereditary problems of fructose intolerance should not take this medicine. May have a mild laxative effect. The caloric value of maltitol is 2.3 kcal\/g. Nurofen Fever and Pain does not contain sugar and is therefore indicated for those patients who need to control their intake of sugars and calories. This medicine contains 9.08 mg of \u003cb\u003esodium\u003c\/b\u003e per 5 ml equivalent to 0.45% of the WHO recommended maximum daily intake which corresponds to 2 g of sodium for an adult. NUROFEN FEVER AND PAIN Children 100mg\/5ml oral suspension strawberry flavor without sugar contains 11.75 mg of \u003cb\u003epropylene glycol\u003c\/b\u003e (present in the strawberry flavour) in 5 ml. Coadministration with any alcohol dehydrogenase substrate such as ethanol may induce serious adverse effects in neonates. NUROFEN FEVER AND PAIN Children 100mg\/5ml sugar-free orange flavor oral suspension contains only a very small quantity of gluten (from\u003cb\u003ewheat starch\u003c\/b\u003e present in the orange flavour). This medicine is considered (gluten-free) and is very unlikely to cause problems for a celiac patient. A 5 ml dose contains no more than 0.225 micrograms of gluten. If the patient is allergic to wheat (condition other than celiac disease) he should not take this medicine.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eINTERACTIONS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cb\u003eIbuprofen should be avoided in association with\u003c\/b\u003e: • Acetylsalicylic acid: Concomitant administration of ibuprofen and acetylsalicylic acid is generally not recommended due to the potential for increased side effects. Experimental data indicate that ibuprofen can inhibit the effects of low-dose acetylsalicylic acid on platelet aggregation when the drugs are administered concomitantly. However, the paucity of data and the uncertainties relating to the application of data extrapolated ex vivo to the clinical situation do not allow definitive conclusions to be drawn on the regular use of ibuprofen; Clinically relevant effects resulting from occasional use of ibuprofen are unlikely (see section 5.1). • \u003cb\u003eOther NSAIDs including selective cyclooxygenase-2 inhibitors\u003c\/b\u003e: avoid the simultaneous use of two or more analgesics, antipyretics, non-steroidal anti-inflammatory drugs: increased risk of side effects (see section 4.4). \u003cb\u003eIbuprofen should be used with caution in combination with:\u003c\/b\u003e • corticosteroids: increased risk of gastrointestinal ulceration or haemorrhage (see section 4.4); • quinolone antibiotics: data from animal studies indicate that NSAIDs may increase the risk of seizures associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may have an increased risk of developing seizures; • anticoagulants, such as warfarin: NSAIDs can increase the effects of anticoagulants (see section 4.4); • antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding (see section 4.4); • phenytoin: Concomitant use of Nurofen Fever and Pain with phenytoin may increase serum levels of these medicines. Correct use of the drugs (administered for a maximum period of 3 days) does not normally require monitoring of serum phenytoin levels. • antidiabetics: an increase in the hypoglycaemic effect of sulfonylureas is possible. In the case of simultaneous treatment, monitoring of blood glucose levels is recommended. • antivirals, such as ritonavir: possible increase in the concentration of NSAIDs; • ciclosporin: increased risk of nephrotoxicity; • mifepristone: NSAIDs must not be administered in the 8-12 days following taking mifepristone as they can reduce its effectiveness; • cytotoxics, such as methotrexate: reduction of excretion (increased risk of toxicity); • lithium: reduction of excretion (increased risk of toxicity); • tacrolimus: increased risk of nephrotoxicity; • uricosurics, such as probenecid and sulfinpyrazone: slow the excretion of NSAIDs (increase in plasma concentrations); • methotrexate: potential increase in plasma concentrations of methotrexate; • zidovudine: increased risk of blood toxicity when NSAIDs are used in combination with zidovudine. There are demonstrations of increased risk of haemarthrosis and hematomas in HIV (+) haemophiliacs if treated simultaneously with zidovudine and ibuprofen; • anti-hypertensives, (ACE inhibitors and angiotensin II antagonists) and diuretics: NSAIDs can reduce the effect of diuretics and other antihypertensive drugs. In some patients with compromised renal function (e.g. dehydrated patients or elderly patients with compromised renal function) co-administration of an ACE inhibitor or an angiotensin II antagonist and agents that inhibit the cyclo-oxygenase system may lead to further deterioration of renal function, including possible acute renal failure, which is usually reversible. These interactions should be considered in patients taking Nurofen Fever and Pain concomitantly with ACE inhibitors or angiotensin II antagonists. Therefore, the combination should be administered with caution, especially in elderly patients. Patients should be adequately hydrated and consideration should be given to monitoring renal function after initiation of concomitant therapy and periodically. • potassium-sparing diuretics: concomitant administration of Nurofen Fever and Pain and potassium-sparing diuretics may lead to hyperkalaemia • CYP2C9 inhibitors: Concomitant administration of ibuprofen and CYP2C9 inhibitors may increase exposure to ibuprofen (CYP2C9 substrate). In a study with voriconazole and fluconazole (CYP2C9 inhibitors), an increased exposure to S(+)-ibuprofen by approximately 80% to 100% was demonstrated. Reduction of the ibuprofen dose should be considered when strong CYP2C9 inhibitors are coadministered, particularly when high doses of ibuprofen are administered with voriconazole or fluconazole. • cardiac glycosides (Digoxin): NSAIDs can worsen heart failure, reduce VGF (glomerular filtration rate) and increase plasma glycoside levels.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eSIDE EFFECTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eThe list of the following side effects includes all those that have been recognized during treatment with ibuprofen for short periods of treatment and for daily doses up to a maximum of 1200 mg. In the case of high-dose therapies for chronic or prolonged pathologies, other undesirable effects may occur. Adverse reactions associated with the administration of ibuprofen are listed below according to system organ class and frequency. Frequencies are defined as: Very common (≥1\/10); Common (≥1\/100, \u003c1\/10); Uncommon (≥1\/1,000, \u003c1\/100); Rare (≥1\/10,000, \u003c1\/1,000) ; Very rare (\u003c1\/10,000); Not known (frequency cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.\u003c\/p\u003e\n\u003cp\u003eInfections and infestations - Frequency: Rare. Adverse reaction: Cystitis, rhinitis.\u003c\/p\u003e\n\u003cp\u003eInfections and infestations - Frequency: Very rare. Adverse reaction: Worsening of infection-related inflammation (e.g. development of necrotizing fasciitis), in exceptional cases severe skin infections and soft tissue complications have been reported during a chickenpox infection.\u003c\/p\u003e\n\u003cp\u003eBlood and lymphatic system disorders - Frequency: Very rare. Adverse reaction: Hematopoiesis disorders ¹\u003c\/p\u003e\n\u003cp\u003eImmune system disorders - Frequency: Uncommon. Adverse reaction: Hypersensitivity reactions manifested by urticaria and pruritus²\u003c\/p\u003e\n\u003cp\u003eImmune system disorders - Frequency: Very rare. Adverse reaction: Severe hypersensitivity reactions including swelling of the face, tongue and larynx, dyspnoea, tachycardia, hypotension (anaphylaxis, angioedema or severe shock). Asthma exacerbation.\u003c\/p\u003e\n\u003cp\u003eMetabolism and nutrition disorders - Frequency: Not known. Adverse reaction: Fluid retention and decreased appetite³.\u003c\/p\u003e\n\u003cp\u003ePsychiatric disorders - Frequency: Not known. Adverse reaction: Irritability\u003c\/p\u003e\n\u003cp\u003ePsychiatric disorders - Frequency: Rare. Adverse reaction: Depression, insomnia, difficulty concentrating, emotional lability, hearing disorders.\u003c\/p\u003e\n\u003cp\u003eNervous system disorders - Frequency: Uncommon. Adverse reaction: Headache, dizziness, drowsiness, convulsions, agitation, tiredness.\u003c\/p\u003e\n\u003cp\u003eNervous system disorders - Frequency: Very rare. Adverse reaction: Aseptic meningitis4.\u003c\/p\u003e\n\u003cp\u003eNervous system disorders - Frequency: Rare. Adverse reaction: Cerebrovascular haemorrhage.\u003c\/p\u003e\n\u003cp\u003eEye disorders - Frequency: Rare. Adverse reaction: Dry eyes.\u003c\/p\u003e\n\u003cp\u003eEye disorders - Frequency: Uncommon. Adverse reaction: Visual disturbances.\u003c\/p\u003e\n\u003cp\u003eEar and labyrinth disorders - Frequency: Not known. Adverse reaction: Tinnitus.\u003c\/p\u003e\n\u003cp\u003eCardiac disorders - Frequency: Very rare. Adverse reaction: Myocardial infarction.\u003c\/p\u003e\n\u003cp\u003eCardiac disorders - Frequency: Not known. Adverse reaction: Heart failure and edema5.\u003c\/p\u003e\n\u003cp\u003eCardiac disorders - Frequency: Rare. Adverse reaction: Palpitations.\u003c\/p\u003e\n\u003cp\u003eVascular disorders - Frequency: Not known. Adverse reaction: Hypertension5 and shock.\u003c\/p\u003e\n\u003cp\u003eRespiratory, thoracic and mediastinal disorders - Frequency: Not known. Adverse reaction: Respiratory tract reactivity including asthma, laryngeal obstruction, bronchospasm or apnea, dyspnea.\u003c\/p\u003e\n\u003cp\u003eGastrointestinal disorders - Frequency: Uncommon. Adverse reaction: Abdominal pain, nausea and dyspepsia6.\u003c\/p\u003e\n\u003cp\u003eGastrointestinal disorders - Frequency: Rare. Adverse reaction: Diarrhoea, flatulence, dry mouth, constipation and vomiting.\u003c\/p\u003e\n\u003cp\u003eGastrointestinal disorders - Frequency: Very rare. Adverse reaction: Peptic ulcer, gastrointestinal perforation or bleeding, melena and haematemesis7. Mouth ulcerations and gastritis.\u003c\/p\u003e\n\u003cp\u003eGastrointestinal disorders - Frequency: Not known. Adverse reaction: Exacerbation of colitis and Crohn's disease8, pancreatitis, duodenitis, esophagitis.\u003c\/p\u003e\n\u003cp\u003eHepatobiliary disorders - Frequency: Very rare. Adverse reaction: Liver dysfunction, hepatitis, jaundice, hepatorenal syndrome, hepatic necrosis, hepatic failure.\u003c\/p\u003e\n\u003cp\u003eSkin and subcutaneous tissue disorders - Frequency: Uncommon. Adverse reaction: Various skin rashes²\u003c\/p\u003e\n\u003cp\u003eSkin and subcutaneous tissue disorders - Frequency: Very rare. Adverse reaction: Bullous reactions including Stevens-Johnson syndrome, erythema multiforme and toxic epidermal necrolysis².\u003c\/p\u003e\n\u003cp\u003eSkin and subcutaneous tissue disorders - Frequency: Rare. Adverse reaction: Exfoliative dermatitis, alopecia, photosensitivity reactions.\u003c\/p\u003e\n\u003cp\u003eSkin and subcutaneous tissue disorders - Frequency: Not known. Adverse reaction: Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), acute generalized exanthematous pustulosis (PEAG).\u003c\/p\u003e\n\u003cp\u003eRenal and urinary disorders - Frequency: Rare. Adverse reaction: Tubular necrosis, glomerular nephritis, polyuria, hematuria.\u003c\/p\u003e\n\u003cp\u003eRenal and urinary disorders - Frequency: Very rare. Adverse reaction: Acute renal failure9.\u003c\/p\u003e\n\u003cp\u003eDiagnostic tests - Frequency: Rare. Adverse reaction: Decreased hematocrit levels.\u003c\/p\u003e\n\u003cp\u003eDiagnostic tests - Frequency: Very rare. Adverse reaction: Decreased hemoglobin levels.\u003c\/p\u003e\n\u003cp\u003e\u003cb\u003eDescription of some adverse reactions\u003c\/b\u003e \u003csup\u003e1\u003c\/sup\u003e Hematopoiesis disorders including anemia, aplastic anemia, hemolytic anemia (positive Coombs test), leukopenia, neutropenia, thrombocytopenia (with or without purpura), eosinophilia, pancytopenia, and agranulocytosis. The first symptoms may be: fever, sore throat, superficial mouth ulcers, flu-like symptoms, marked fatigue, nosebleeds and bleeding. In these cases the patient should be advised to stop taking the medicine immediately, to avoid any self-medication medicine containing analgesics or antipyretics and to consult his doctor. Rarely congestive heart failure in patients with impaired cardiac function. ² Hypersensitivity reactions: these reactions include a) non-specific allergic reactions and anaphylaxis, fever, chills, b) respiratory tract reactivity including asthma, aggravated asthma, bronchospasm (see section 4.3 and 4.4) or dyspnoea or c) various skin conditions including various skin rashes (including maculopapular in nature), pruritus, urticaria with or without angioedema, purpura, angioedema and much rarely, bullous and exfoliative dermatitis including toxic epidermal necrolysis, Stevens-Johnson syndrome and erythema multiforme. ³ Decreased appetite: generally resolves rapidly upon discontinuation of treatment (see section 4.4). \u003csup\u003e4\u003c\/sup\u003e The pathogenetic mechanism of drug-induced aseptic meningitis is not completely known. However, the data available on aseptic meningitis related to the administration of NSAIDs leads us to think of an immune reaction (due to a temporal relationship with the intake of the medicine and the disappearance of symptoms after discontinuation of treatment). Of note, individual cases of symptoms of aseptic meningitis (such as stiff neck, neck numbness, headache, nausea, vomiting, fever and disorientation) have been observed during treatment with ibuprofen in patients with autoimmune diseases (such as systemic lupus erythromatosus, mixed connective tissue disease).\u003csup\u003e5\u003c\/sup\u003e Heart failure and edema: Clinical studies and epidemiological data suggest that the use of ibuprofen, especially at high doses (2400 mg\/day) and for long-term treatments, may be associated with a modest increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke) (see section 4.4). Congestive heart failure in patients with impaired cardiac function. \u003csup\u003e6\u003c\/sup\u003e The most commonly observed adverse events are gastrointestinal in nature. Gastric discomfort can be reduced by taking the medicine on a full stomach. \u003csup\u003e7\u003c\/sup\u003e Peptic ulcers, gastrointestinal perforation or hemorrhage, melena, and sometimes fatal hematemesis may occur. \u003csup\u003e8\u003c\/sup\u003e Exacerbation of colitis and Crohn's disease (see section 4.4). \u003csup\u003e9\u003c\/sup\u003e Acute renal failure especially in case of long-term therapy, associated with increased serum urea levels and edema. Papillary necrosis may occur. \u003cb\u003eReporting of suspected adverse reactions\u003c\/b\u003e Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit\/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at: https:\/\/www.aifa.gov.it\/content\/segnalazioni-reazioniavverse\u003ci\u003e. \u003c\/i\u003e\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eOVERDOSE\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cu\u003eToxicity \u003c\/u\u003e Signs and symptoms of toxicity were generally not observed at doses below 100 mg\/kg in children or adults. However, in some cases supportive treatment may be necessary. Children have been observed to exhibit signs and symptoms of toxicity after ingesting ibuprofen at doses of 400 mg\/kg or greater. The half-life of the drug in case of overdose is 1.5-3 hours. \u003cu\u003eSymptoms \u003c\/u\u003e Most patients who accidentally ingest clinically relevant quantities of ibuprofen will experience symptoms within 4 to 6 hours. The most commonly reported overdose symptoms include: nausea, vomiting, abdominal pain, lethargy, and drowsiness. Central nervous system (CNS) effects include headache, tinnitus, dizziness, seizures, and loss of consciousness. Nystagmus, metabolic acidosis, hypothermia, renal effects, gastrointestinal bleeding, coma, apnea, diarrhea and CNS and respiratory depression have also been reported rarely. Disorientation, arousal, fainting and cardiovascular toxicity including hypotension, bradycardia and tachycardia have been reported. In cases of significant overdose, renal failure and liver damage are possible. In cases of severe poisoning, metabolic acidosis and a prolongation of the prothrombin time (INR) may occur, probably caused by interference with the action of coagulation factors present in the circulation. In asthmatic subjects, an exacerbation of the symptoms of the disease may occur. \u003cu\u003eTreatment \u003c\/u\u003e There is no specific antidote for ibuprofen overdose. In case of overdose, symptomatic and supportive treatment is therefore indicated and must include maintaining a patent airway and monitoring cardiac function and vital signs until the patient is stabilised. Particular attention is due to the control of blood pressure, acid-base balance and any gastrointestinal bleeding. Administration of activated charcoal should be considered within one hour of ingesting a potentially toxic quantity. Alternatively, in adults, gastric lavage should be considered within one hour of ingestion of a potentially life-threatening overdose. Adequate diuresis must be ensured and renal and hepatic functions must be closely monitored. The patient must remain under observation for at least four hours following ingestion of a potentially toxic amount of drug. Any occurrence of frequent or prolonged convulsions should be treated with intravenous diazepam or lorazepam. If ibuprofen has already been absorbed, alkaline substances should be administered to promote excretion of the acidic ibuprofen in the urine. Administer bronchodilators in case of asthma. Depending on the patient's clinical condition, other support measures may be necessary. For more information, contact your local poison control center.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003ePREGNANCY AND BREASTFEEDING\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eChildren under the age of 12 are unlikely to become pregnant or breastfeed. Furthermore, in such circumstances the following considerations must be kept in mind. \u003cu\u003ePregnancy \u003c\/u\u003e Inhibition of prostaglandin synthesis can negatively affect pregnancy and\/or embryo\/foetal development. Results of epidemiological studies suggest an increased risk of miscarriage and cardiac malformation and gastroschisis after the use of a prostaglandin synthesis inhibitor in the early stages of pregnancy. The absolute risk of cardiac malformations increased from less than 1% to approximately 1.5%. The risk has been thought to increase with dose and duration of therapy. In animals, the administration of prostaglandin synthesis inhibitors has been shown to cause an increase in pre- and post-implantation loss and embryo-foetal mortality. Furthermore, an increased incidence of various malformations, including cardiovascular malformations, has been reported in animals administered prostaglandin synthesis inhibitors during the organogenetic period. From the 20th\u003csup\u003ea\u003c\/sup\u003e week of pregnancy onwards, the use of ibuprofen could cause oligohydramnios resulting from fetal renal dysfunction. This condition may be experienced shortly after starting treatment and is usually reversible upon discontinuation of treatment. Additionally, cases of constriction of the ductus arteriosus have been reported following treatment in the second trimester, most of which resolved after treatment was discontinued. Therefore, during the first and second trimester of pregnancy ibuprofen should not be administered unless strictly necessary. If ibuprofen is used by a woman planning pregnancy, or during the first and second trimester of pregnancy, the lowest possible dose should be used for the shortest possible time. Following exposure to ibuprofen for several days from the 20th\u003csup\u003ea\u003c\/sup\u003e week of gestation onwards, antenatal monitoring for oligohydramnios and ductus arteriosus constriction should be considered. In case of oligohydramnios or constriction of the ductus arteriosus, treatment with ibuprofen should be discontinued. During the third trimester of pregnancy, all inhibitors of prostaglandin synthesis can expose the fetus to: - cardiopulmonary toxicity (premature constriction\/closure of the ductus arteriosus and pulmonary hypertension); - renal dysfunction (see above); the mother and the newborn, at the end of pregnancy, to: - possible prolongation of bleeding time, an anti-aggregating effect which can occur even at very low doses; - inhibition of uterine contractions resulting in delayed or prolonged labor. Consequently, Nurofen Fever and Pain is contraindicated during the third trimester of pregnancy (see sections 4.3 and 5.3). \u003cu\u003eBreastfeeding \u003c\/u\u003e There is limited data showing that ibuprofen can pass in low concentrations into breast milk and is unlikely to have any adverse effects on newborns.\u003cu\u003eFertility \u003c\/u\u003e There is evidence that medicinal products that inhibit cyclooxygenase\/prostaglandin synthesis may cause impairment of female fertility by affecting ovulation. This effect is reversible after discontinuation of treatment.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eEFFECTS ON DRIVING ABILITY\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eNot relevant, considering the age of the patient.\u003c\/p\u003e","brand":"Reckitt Benckiser","offers":[{"title":"Default Title","offer_id":51730205016391,"sku":"034102261","price":13.3,"currency_code":"EUR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0564\/4989\/2467\/files\/reckitt-benckiser-h-it-spa-nurofen-febbre-e-dolore-bambini-100-mg-5-ml-150-ml-sospensione-orale-senza-zucchero-gusto-fragola-farmacia-dottor-tili-1213791387.jpg?v=1767139331"},{"product_id":"nurofen-junior-125-mg-10-supposte-bambini","title":"Nurofen Junior 125 mg 10 suppositories children","description":"\u003cp\u003e\u003cstrong\u003eINDICATIONS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eShort-term symptomatic treatment of mild and moderate pain. Short-term symptomatic treatment of fever. Nurofenjunior suppositories are indicated when oral administration is not recommended, e.g. in case of vomiting. Nurofenjunior is indicated in children from 12.5 kg (2 years) to 20.5 kg (6 years) body weight\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eACTIVE INGREDIENTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eEach suppository contains: ibuprofen 125 mg For the complete list of excipients, see section 6.1.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eEXCIPIENTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eSolid semi-synthetic glycerides\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eCONTRAINDICATIONS AND SIDE EFFECTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eHypersensitivity to the active substance or to any of the excipients listed in paragraph 6.1. Patients who have previously shown hypersensitivity reactions (e.g. bronchospasm, angioedema, asthma, rhinitis or urticaria) associated with acetylsalicylic acid, ibuprofen or other non-steroidal anti-inflammatory medicinal products. History of gastrointestinal bleeding or perforation associated with previous treatment with NSAIDs. In the presence or history of recurrent peptic ulcer\/haemorrhage (two or more confirmed episodes of ulceration or bleeding). Patients with severe renal insufficiency, severe hepatic insufficiency or severe heart failure. Patients with a history of cerebrovascular bleeding or other active bleeding. Patients with unexplained disorders of blood formation. Patients with severe dehydration (caused by vomiting, diarrhea or insufficient fluid intake). In the last trimester of pregnancy (see section 4.6). Children weighing less than 12.5 kg (under 2 years of age).\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eDOSAGE\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cu\u003eDosage\u003c\/u\u003e Only for a short period of treatment. The maximum daily dose of ibuprofen is 20-30 mg\/kg of body weight, divided into 3 or 4 administrations. This means: Children with a body weight between 12.5 and 17 kg (between 2 and 4 years): 1 suppository at the beginning of treatment, to be repeated, if necessary, after at least 6-8 hours. No more than 3 suppositories should be administered in any 24 hour period. Children with a body weight between 17 and 20.5 kg (between 4 and 6 years): 1 suppository at the beginning of treatment, to be repeated if necessary, after at least 6 hours. No more than 4 suppositories should be administered in any 24 hour period. Nurofenjunior 125 mg suppositories are contraindicated in children weighing less than 12.5 kg (under 2 years of age), as lower dosage suppositories are required (see also section 4.3). Administration in patients with renal or hepatic insufficiency must take place after consulting the doctor. If this medicine is required for more than 3 days, or if symptoms worsen, a doctor should be consulted. Undesirable effects can be minimized by using the lowest effective dose for the shortest possible treatment duration needed to control symptoms (see section 4.4). \u003cu\u003eMethod of administration\u003c\/u\u003e Rectal use\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eCONSERVATION\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eDo not store above 25°C\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eWARNINGS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eSide effects can be minimized by using the lowest effective dose for the shortest possible treatment duration needed to control symptoms (see gastrointestinal and cardiovascular effects below). \u003cb\u003eElderly people\u003c\/b\u003e: Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which may be fatal. Elderly people have an increased risk of consequences from adverse reactions. Caution is required in patients with: • Systemic lupus erythematosus or mixed connective tissue disease, due to the increased risk of aseptic meningitis (see section 4.8). • Congenital disorders of porphyrin metabolism (e.g., acute intermittent porphyria). • Gastrointestinal disorders and chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease) (see section 4.8). • History of hypertension and\/or heart failure since fluid retention and edema have been reported in association with NSAID therapy • Renal damage, as renal function may worsen (see sections 4.3 and 4.8). • Liver dysfunction (see sections 4.3 and 4.8) • Immediately after major surgery • Hay fever, nasal polyps or chronic obstructive respiratory disease, as there is an increased risk of allergic reactions in these patients. These may manifest as asthma attacks (so-called “analgesic asthma”), Quincke's edema or urticaria • In patients who have already experienced allergic reactions to other substances, as they are at higher risk of developing hypersensitivity reactions following the administration of Nurofenjunior \u003cb\u003eOther NSAIDs\u003c\/b\u003e: the use of Nurofenjunior in children should be avoided concomitantly with the administration of other NSAIDs including selective cyclooxygenase-2 inhibitors. \u003cb\u003eMasking of symptoms of underlying infections\u003c\/b\u003e Nurofenjunior may mask the symptoms of infection, which could delay starting appropriate treatment and therefore worsen the outcome of the infection. This has been observed in community-acquired bacterial pneumonia and bacterial complications of chickenpox. When Nurofenjunior is administered for the relief of fever or pain related to infection, monitoring of the infection is recommended. In non-hospital settings, the patient should seek medical attention if symptoms persist or worsen. \u003cb\u003eCardiovascular and cerebrovascular effects\u003c\/b\u003e: caution is required (advice from a doctor or pharmacist) before administering Nurofenjunior to patients with a history of hypertension and\/or heart failure, since fluid retention, hypertension and edema have been reported following NSAID therapy. Clinical studies and epidemiological data suggest that the use of ibuprofen, especially at high doses (2400 mg\/day) and for long-term treatments, may be associated with a modest increase in the risk of events arterial thrombosis (e.g. myocardial infarction or stroke). In general, epidemiological studies do not indicate that low doses of ibuprofen (e.g. ≤ 1200 mg\/day) are associated with an increased risk of myocardial infarction. \u003cb\u003eGastrointestinal (GI) effects\u003c\/b\u003e: During treatment with all NSAIDs, gastrointestinal bleeding, ulceration or perforation, which may be fatal, have been reported at any time, with or without warning symptoms or previous history of serious gastrointestinal events, disorders of the rectum and anus. The risk of gastrointestinal haemorrhage, ulceration or perforation is higher with increased doses of NSAIDs, in patients with a history of ulcer, particularly if complicated by haemorrhage or perforation (see section 4.3) and in the elderly. These patients should start treatment with the lowest dose. For these patients and also for patients taking low doses of acetylsalicylic acid or other drugs that may increase the risk of gastrointestinal events, the concomitant use of gastroprotective agents (e.g. misoprostol or proton pump inhibitors) should be considered (see below and section 4.5). Patients with a history of gastrointestinal toxicity, particularly if elderly, should report any unusual abdominal symptoms (especially gastrointestinal bleeding) particularly in the initial stages of treatment. Caution should be exercised in patients taking concomitant medications that may increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or antiplatelet agents such as acetylsalicylic acid (see section 4.5). When gastrointestinal bleeding or ulceration occurs in patients taking Nurofenjunior, treatment should be discontinued. NSAIDs should be administered with caution to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated (see section 4.8). \u003cb\u003eRespiratory\u003c\/b\u003e: Bronchospasm may worsen in patients with or with a history of bronchial asthma, chronic rhinitis, sinusitis, nasal polyposis, or allergic disease. \u003cb\u003eOther considerations:\u003c\/b\u003e Severe acute hypersensitivity reactions (e.g. anaphylactic shock) are observed very rarely. At the first signs of hypersensitivity reaction after administration\/taking of Nurofenjunior, therapy should be discontinued. Medical rescue measures, in line with the symptoms, must be undertaken by specialized personnel. Ibuprofen, the active ingredient in Nurofenjunior, can temporarily inhibit the function of platelets (thrombocyte aggregation). It is therefore recommended to carefully monitor patients with coagulation disorders. In case of prolonged administration of Nurofenjunior, regular monitoring of liver values, renal function as well as blood counts is required. Prolonged use of any type of pain reliever for headaches can worsen symptoms. If this situation occurs or is suspected, the doctor should be consulted and treatment should be suspended. The diagnosis of medication overuse headache (MOH) should be suspected in patients who experience frequent or daily headaches despite or because of regular use of headache medications. Side effects related to the active ingredient, in particular those relating to the gastrointestinal tract or central nervous system, may be increased by taking NSAIDs in combination with alcohol. In patients with heart failure, renal or hepatic failure, in those taking diuretics or who have undergone major surgery resulting in dehydration, monitoring of urine output and renal function should be considered. \u003cb\u003eRenal disorders\u003c\/b\u003e: in general, the habitual use of analgesics, especially the combination of different analgesic substances, can cause permanent kidney damage, with risk of renal failure (analgesic nephropathy). \u003cb\u003ePediatric population\u003c\/b\u003e: There is a risk of kidney damage in dehydrated children. \u003cb\u003eCompromised female fertility\u003c\/b\u003e: see paragraph 4.6. \u003cb\u003eSevere skin reactions\u003c\/b\u003e: Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported very rarely in association with the use of NSAIDs (see section 4.8). Patients appear to be at higher risk in the early stages of therapy: the onset of the reaction occurs in most cases within the first month of treatment. Acute generalized exanthematous pustulosis (PEAG) has been reported in connection with ibuprofen-containing medicinal products. Nurofenjunior should be discontinued at the first appearance of signs and symptoms of severe skin reactions, such as rash, mucosal lesions or any other sign of hypersensitivity. Chickenpox can exceptionally cause serious infectious complications to the skin and soft tissues. It is advisable to avoid using Nurofenjunior in case of chickenpox.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eINTERACTIONS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cb\u003eIbuprofen should not be used in combination with:\u003c\/b\u003e Acetylsalicylic acid (aspirin): unless low-dose acetylsalicylic acid, as per common clinical practice, has been advised by the doctor, as it may increase the risk of adverse reactions (see section 4.4). Other NSAIDs including selective cyclooxygenase 2 inhibitors: avoid concomitant use of two or more NSAIDs as it may increase the risk of adverse reactions (see section 4.4) Experimental data suggest that ibuprofen may inhibit the effects of low-dose acetylsalicylic acid on platelet aggregation when the drugs are administered concomitantly. However, the paucity of data and the uncertainties relating to the application of data extrapolated ex vivo to the clinical situation do not allow definitive conclusions to be drawn for the regular use of ibuprofen and no relevant clinical effect is considered probable in case of occasional use of ibuprofen (see section 5.1). \u003cb\u003eIbuprofen (like other NSAIDs) should be used with caution in association with:\u003c\/b\u003e - Corticosteroids: increased risk of gastrointestinal ulceration or haemorrhage (see section 4.4) - Anticoagulants: NSAIDs may increase the effects of anticoagulants, such as warfarin (see section 4.4) - Phenytoin: concomitant use of Nurofenjunior with phenytoin may increase the serum levels of these medicines. Correct use of the drugs (administered for a maximum period of 3 days) does not normally require monitoring of serum phenytoin levels. - Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs): may increase the risk of gastrointestinal bleeding (see section 4.4). - Anti-hypertensives (ACE inhibitors, beta-blockers and angiotensin II antagonists) and diuretics: NSAIDs can decrease the effectiveness of these medicines. In some patients with compromised renal function (e.g. dehydrated patients or elderly patients with compromised renal function) the co-administration of an ACE inhibitor, a beta-blocker or an angiotensin II antagonist and agents that inhibit cyclooxygenases may lead to a further deterioration of renal function, including possible acute renal failure, which is usually reversible. Therefore, the combination should be administered with caution, especially in elderly patients. Patients should be adequately hydrated and consideration should be given to monitoring renal function after initiation of concomitant therapy and at regular intervals thereafter. Diuretics may increase the risk of NSAID nephrotoxicity. - Lithium: there is evidence to support a potential increase in plasma lithium levels. Correct use of the drugs (administered for a maximum period of 3 days) does not normally require monitoring of serum lithium levels. - Probenecid and sulfinpyrazone: Medicines containing probenecid or sulfinpyrazone may delay the excretion of ibuprofen. - Potassium-sparing diuretics: concomitant administration of Nurofenjunior and potassium-sparing diuretics may lead to hyperkalemia (monitoring of serum potassium is recommended). - Cardiac glucosides (Digoxin): NSAIDs can worsen heart failure, reduce GFR and plasma levels of glucosides. Concomitant use of Nurofenjunior with digoxin preparations may increase serum levels of these medicines. Correct use of the drugs (administered for a maximum period of 3 days) does not normally require monitoring of serum digoxin levels. - Methotrexate: there is evidence to support a potential increase in plasma levels of methotrexate. Administration of Nurofenjunior in the 24 hours before and after the administration of methotrexate may lead to high concentrations of methotrexate and an increase in its toxic effects. - Tacrolimus: the risk of nephrotoxicity increases if the two medicines are administered simultaneously. - Ciclosporin: there is limited evidence to support a possible interaction between the two medicines with consequent increased risk of nephrotoxicity. - Zidovudine: there is evidence of an increased risk of haemarthrosis and haematoma in HIV-positive haemophilia patients treated concomitantly with zidovudine and ibuprofen. - Sulfonylureas: clinical studies have shown interactions between nonsteroidal anti-inflammatory drugs and antidiabetics (sulfonylureas). Although no interactions between ibuprofen and sulphonylureas have been described so far, monitoring of blood glucose values ​​is recommended as a precautionary measure during concomitant intake. - Quinolone antibiotics: data from animal studies indicate that NSAIDs may increase the risk of seizures associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may have an increased risk of developing seizures. - CYP2C9 inhibitors: Concomitant administration of ibuprofen and CYP2C9 inhibitors may increase exposure to ibuprofen (CYP2C9 substrate). In a study with voriconazole and fluconazole (CYP2C9 inhibitors), an increased exposure to S(+)-ibuprofen by approximately 80% to 100% was demonstrated. Reduction of the ibuprofen dose should be considered when strong CYP2C9 inhibitors are coadministered, particularly when high doses of ibuprofen are administered with voriconazole or fluconazole.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eSIDE EFFECTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eThe list of the following side effects includes all side effects that have been recognized during treatment with ibuprofen, even those observed during prolonged high-dose therapy in patients with rheumatism. The frequencies reported, which extend beyond reports of very rare side effects, refer to short periods of treatment for daily doses up to a maximum of 1,200 mg of ibuprofen for oral pharmaceutical forms and up to a maximum of 1,800 mg for suppositories. It should be taken into account that the following adverse reactions are predominantly dose-dependent and vary from individual to individual. Adverse reactions associated with the administration of ibuprofen are listed below according to system organ class and frequency. Frequencies are defined as: very common (≥1\/10), common (≥1\/100, \u003c1\/10), uncommon (≥1\/1,000, \u003c1\/100), rare (≥1\/10,000, \u003c1\/1,000), very rare (\u003c1\/10,000), not known (cannot be estimated from the available data). Within each frequency grouping, adverse events are presented in order of decreasing seriousness. The most often observed adverse reactions are gastrointestinal in nature. Adverse reactions are in most cases dose-dependent. In particular, the risk of gastrointestinal bleeding depends on the dosage and duration of treatment. Peptic ulcers, perforation or gastrointestinal haemorrhage, sometimes fatal, may occur, particularly in the elderly (see section 4.4). Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease have been reported following administration of ibuprofen (see section 4.4). Less frequently, gastritis was observed. Edema, hypertension and heart failure have been reported in association with NSAID treatment. Clinical studies and epidemiological data suggest that the use of ibuprofen, particularly at high doses (2,400 mg per day) and for long-term treatment, may be associated with a slightly increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke) (see section 4.4). Worsening of infection-related inflammation (e.g. development of necrotizing fasciitis) associated with the use of non-steroidal anti-inflammatory drugs has been described. This is probably due to the mechanism of action of non-steroidal anti-inflammatory drugs. If signs of an infection occur or worsen while using Nurofenjunior, the patient is recommended to contact a doctor immediately to assess whether anti-infective\/antibiotic therapy is necessary. For prolonged treatments blood counts should be checked regularly. If any symptoms of hypersensitivity reactions occur, the patient should be instructed to immediately inform the doctor and stop taking Nurofenjunior; this can also happen upon first use, in which case immediate medical assistance is required. The patient should be instructed to stop taking the medicine and consult a doctor immediately if severe pain in the upper abdomen or melena or haematemesis occurs.\u003c\/p\u003e\n\u003cp\u003eInfections and infestations - Frequency: Very rare. Adverse reaction: Worsening of infection-related inflammation (e.g. development of necrotizing fasciitis), in exceptional cases severe skin infections and soft tissue complications have been reported during a chickenpox infection.\u003c\/p\u003e\n\u003cp\u003eBlood and lymphatic system disorders - Frequency: Very rare. Adverse reaction: Hematopoietic disorders (anaemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). The first signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, nasal and skin bleeding and bruising. In these cases the patient should be advised to stop taking the medicine immediately, to avoid any self-medication medicine containing analgesics or antipyretics and to consult his doctor.\u003c\/p\u003e\n\u003cp\u003ePsychiatric disorders - Frequency: Very rare. Adverse reaction: Psychotic reactions, depression.\u003c\/p\u003e\n\u003cp\u003eImmune system disorders - Adverse reaction: Hypersensitivity reactions consisting of:¹\u003c\/p\u003e\n\u003cp\u003eImmune system disorders - Frequency: Uncommon. Adverse reaction: Urticaria and itching.\u003c\/p\u003e\n\u003cp\u003eImmune system disorders - Frequency: Very rare. Adverse reaction: Severe hypersensitivity reactions. Symptoms may be: swelling of the face, tongue and larynx, dyspnea, tachycardia, hypotension (anaphylaxis, angioedema or severe shock). Asthma exacerbation.\u003c\/p\u003e\n\u003cp\u003eImmune system disorders - Frequency: Not known. Adverse reaction: Respiratory tract reactivity including asthma, bronchospasm, or dyspnea.\u003c\/p\u003e\n\u003cp\u003eNervous system disorders - Frequency: Uncommon. Adverse reaction: Central nervous system disorders such as headache, dizziness, insomnia, agitation, irritability or tiredness.\u003c\/p\u003e\n\u003cp\u003eNervous system disorders - Frequency: Very rare. Adverse reaction: Aseptic meningitis²\u003c\/p\u003e\n\u003cp\u003eEye disorders - Frequency: Uncommon. Adverse reaction: Visual disturbances.\u003c\/p\u003e\n\u003cp\u003eEar and labyrinth disorders - Frequency: Rare. Adverse reaction: Tinnitus.\u003c\/p\u003e\n\u003cp\u003eCardiac disorders - Frequency: Very rare. Adverse reaction: Heart failure, palpitations and edema, myocardial infarction.\u003c\/p\u003e\n\u003cp\u003eVascular disorders - Frequency: Very rare. Adverse reaction: Hypertension, vasculitis.\u003c\/p\u003e\n\u003cp\u003eGastrointestinal disorders - Frequency: Common. Adverse reaction: Gastrointestinal problems, such as abdominal pain, nausea and dyspepsia. Diarrhea, flatulence, constipation, heartburn, vomiting and slight blood loss in the stomach and\/or intestines which in exceptional cases can cause anemia.\u003c\/p\u003e\n\u003cp\u003eGastrointestinal disorders - Frequency: Uncommon. Adverse reaction: Gastrointestinal ulcers, perforation or gastrointestinal bleeding. Ulcerative stomatitis, worsening of colitis or Crohn's disease (see section 4.4), gastritis, localized rectal irritation.\u003c\/p\u003e\n\u003cp\u003eGastrointestinal disorders - Frequency: Very rare. Adverse reaction: Esophagitis and formation of diaphragmatic-like intestinal structures, pancreatitis.\u003c\/p\u003e\n\u003cp\u003eHepatobiliary disorders - Frequency: Very rare. Adverse reaction: Liver dysfunction, liver damage, particularly in long-term therapy, liver failure, acute hepatitis.\u003c\/p\u003e\n\u003cp\u003eSkin and subcutaneous tissue disorders - Frequency: Uncommon. Adverse reaction: Various skin rashes.\u003c\/p\u003e\n\u003cp\u003eSkin and subcutaneous tissue disorders - Frequency: Very rare. Adverse reaction: Severe forms of skin reactions such as bullous reactions including Stevens-Johnson syndrome, erythema multiforme and toxic epidermal necrolysis, alopecia.\u003c\/p\u003e\n\u003cp\u003eSkin and subcutaneous tissue disorders - Frequency: Not known. Adverse reaction: Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome) Acute generalized exanthematous pustulosis (PEAG). Photosensitivity reactions.\u003c\/p\u003e\n\u003cp\u003eRenal and urinary disorders - Frequency: Rare. Adverse reaction: Rarely, kidney tissue damage (papillary necrosis) may occur.\u003c\/p\u003e\n\u003cp\u003eRenal and urinary disorders - Frequency: Rare. Adverse reaction: and high concentrations of urea in the blood.\u003c\/p\u003e\n\u003cp\u003eRenal and urinary disorders - Frequency: Very rare. Adverse reaction: Formation of edema particularly in patients with arterial hypertension or renal failure, nephrotic syndrome, interstitial nephritis which may be accompanied by acute renal failure.\u003c\/p\u003e\n\u003cp\u003eDiagnostic tests - Frequency: Rare. Adverse reaction: Decreased hemoglobin level in the blood.\u003c\/p\u003e\n\u003cp\u003e\u003cb\u003eDescription of some selected adverse reactions\u003c\/b\u003e \u003csup\u003e1\u003c\/sup\u003e Hypersensitivity reactions have been reported following treatment with ibuprofen. These reactions may include a) non-specific allergic reactions and anaphylaxis, b) respiratory tract reactivity including asthma, worsening of asthma, bronchospasm or dyspnea, or c) various skin conditions including various skin rashes, pruritus, urticaria, purpura, angioedema and very rarely bullous and exfoliative dermatitis (including toxic epidermal necrolysis, Stevens-Johnson syndrome and erythema multiforme)² The pathogenetic mechanism of drug-induced aseptic meningitis is not completely known. However, the data available on aseptic meningitis related to NSAIDs leads us to think of an immune reaction (due to a temporary relationship with the intake of the medicine and the disappearance of symptoms after discontinuation of treatment). Of note, individual cases of symptoms of aseptic meningitis (such as numb neck, headache, nausea, vomiting, fever and disorientation) have been observed during treatment with ibuprofen in patients with pre-existing autoimmune disorders (such as systemic lupus erythematosus, mixed connective tissue disease). \u003cb\u003eReporting of suspected adverse reactions\u003c\/b\u003e Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit\/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https:\/\/www.aifa.gov.it\/content\/segnalazioni-reazioni-avverse\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eOVERDOSE\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eThe risk of toxicity may occur for doses higher than 200 mg\/kg. a) Symptoms of overdose: Symptoms of overdose may include nausea, vomiting, abdominal pain or more rarely diarrhoea. Nystagmus, blurred vision, tinnitus, headache, and gastrointestinal bleeding are also possible. In more serious cases of poisoning, central nervous system toxicity is observed, manifested by vertigo, dizziness, drowsiness, occasionally excitation and disorientation, loss of consciousness or coma. Occasionally patients develop seizures. In cases of severe poisoning, metabolic acidosis may occur. Hypothermia and hyperkalemia may occur, and prothrombin time\/INR may be prolonged, possibly due to interference with the action of circulating coagulation factors. Acute renal failure, liver damage, hypotension, respiratory depression and cyanosis may also occur. In asthmatic subjects, asthma exacerbation may occur. b) Treatment of overdose: There is no specific antidote. Treatment should be symptomatic and supportive and should include maintaining a patent airway and monitoring cardiac function and vital signs until the patient is stabilized. If frequent or prolonged, seizures should be treated with intravenous diazepam or lorazepam. Administer bronchodilators in case of asthma. The local poison center should be contacted for medical advice.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003ePREGNANCY AND BREASTFEEDING\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cu\u003ePregnancy\u003c\/u\u003e Inhibition of prostaglandin synthesis can negatively influence pregnancy and\/or embryo\/foetal development. Results of epidemiological studies suggest an increased risk of miscarriage and cardiac malformations and gastroschisis after the use of a prostaglandin synthesis inhibitor in the early stages of pregnancy. The absolute risk of cardiac malformations was increased from less than 1% to approximately 1.5%. The risk is thought to increase with the dose and duration of therapy. In animals, the administration of prostaglandin synthesis inhibitors has been shown to cause an increase in pre- and post-implantation loss and embryo-fetal mortality. Furthermore, an increased incidence of various malformations, including cardiovascular ones, has been reported in animals to which prostaglandin synthesis inhibitors were administered during the organogenetic period. During the first and second trimester of pregnancy, ibuprofen should not be administered unless strictly necessary. If ibuprofen is used by a woman trying to conceive, or during the first and second trimester of pregnancy, the dose and duration of treatment should be kept as low as possible. During the third trimester of pregnancy, all inhibitors of prostaglandin synthesis can expose the fetus to: - cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension); - renal dysfunction which may progress to renal failure with oligo-hydramnios; the mother and the newborn, at the end of pregnancy, to: - possible prolongation of bleeding time, an anti-aggregating effect which can occur even at very low doses; - inhibition of uterine contractions resulting in delayed or prolonged labor. Consequently, ibuprofen is contraindicated during the third trimester of pregnancy.\u003cu\u003eBreastfeeding\u003c\/u\u003e Ibuprofen and metabolites pass into breast milk only in small quantities. Since to date there are no known side effects in infants, interruption of breastfeeding is usually not required if the medicine is taken at the recommended doses for fever and pain for short-term treatments. \u003cu\u003eFertility\u003c\/u\u003e There is evidence that medicinal products that inhibit cyclooxygenase\/prostaglandin synthesis may cause impairment of female fertility by affecting ovulation. This effect is reversible after discontinuation of treatment.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eEFFECTS ON DRIVING ABILITY\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eFor short-term treatments, Nurofenjunior has negligible or no effect on the ability to drive or use machines.\u003c\/p\u003e","brand":"Reckitt Benckiser","offers":[{"title":"Default Title","offer_id":51730205409607,"sku":"041610027","price":11.4,"currency_code":"EUR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0564\/4989\/2467\/files\/reckitt-benckiser-h-it-spa-nurofen-junior-125-mg-10-supposte-bambini-farmacia-dottor-tili-1213791380.jpg?v=1767139548"},{"product_id":"nurofenteen-200-mg-12-compresse-orosolubili-limone","title":"Nurofenteen 200 mg 12 orodispersible tablets lemon","description":"\u003cp\u003e\u003cstrong\u003eINDICATIONS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eMild or moderate painful symptoms such as headache, toothache, menstrual pain. Fever. NUROFENTEEN is indicated for adults and adolescents over 12 years of age.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eACTIVE INGREDIENTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eEach orodispersible tablet contains 200 mg of ibuprofen. Excipients with known effects: 15.0 mg aspartame\/orodispersible tablet 2.37 mg sodium\/orodispersible tablet For the full list of excipients, see section 6.1.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eEXCIPIENTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eEthyl cellulose, precipitated silicon dioxide, hypromellose, mannitol, aspartame (E951), croscarmellose sodium, magnesium stearate, flavoring (lemon).\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eCONTRAINDICATIONS AND SIDE EFFECTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003ePatients with hypersensitivity to the active substance or to any of the excipients listed in paragraph 6.1. Patients who have previously shown hypersensitivity reactions (e.g. bronchospasm, asthma, rhinitis, angioedema or urticaria) following the use of acetylsalicylic acid, ibuprofen or other non-steroidal anti-inflammatory drugs. Patients with severe hepatic impairment, severe renal impairment or severe heart failure (NYHA class IV). Patients with a history of gastrointestinal bleeding or perforation, related to previous therapy with NSAIDs (non-steroidal anti-inflammatory drugs). Patients with current or previous recurrent peptic ulcers\/haemorrhages (two or more distinct episodes of proven ulceration or bleeding). Patients with active cerebrovascular hemorrhage or other types of hemorrhage. Patients with unexplained disorders of hematopoiesis. Patients with severe dehydration (caused by vomiting, diarrhea or insufficient fluid intake). During the last trimester of pregnancy (see section 4.6).\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eDOSAGE\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cu\u003eDosage\u003c\/u\u003e Do not administer to children under 12 years of age.\u003cb\u003eAdults and adolescents over 12 years old\u003c\/b\u003e: initial dose of 200 to 400 mg of ibuprofen, then, if necessary, 200 to 400 mg of ibuprofen every 4 to 6 hours. Do not exceed a dose of 1200 mg of ibuprofen in 24 hours. \u003cb\u003eElderly\u003c\/b\u003e: No changes to the dosage schedule are required. Only for a short period of treatment. If the use of the medicine is necessary for more than 3 days in adolescents or in the case of worsening of symptoms, the doctor should be consulted. If the use of the medicine in adults is necessary for more than 3 days in case of fever or for more than 4 days in the treatment of pain, or in the case of worsening of symptoms, the patient should be advised to consult a doctor. Undesirable effects can be minimized by using the lowest effective dose for the shortest possible treatment duration needed to control symptoms (see section 4.4). \u003cu\u003eMethod of administration\u003c\/u\u003e \u003cu\u003eOral use\u003c\/u\u003e \u003cu\u003ePlace one tablet on the tongue, let it dissolve, then swallow. Water intake is not necessary\u003c\/u\u003e. Patients with gastric sensitivity problems are advised to take NUROFENTEEN on a full stomach.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eCONSERVATION\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eStore at a temperature not exceeding 25°C.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eWARNINGS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eSide effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see Gastrointestinal and Cardiovascular Risks below). \u003cb\u003eElderly people\u003c\/b\u003e: Elderly patients present a greater frequency of adverse reactions to NSAIDs, in particular gastrointestinal haemorrhage and perforation which can be fatal (see section 4.2). Elderly patients are at greater risk of consequences from adverse reactions. Caution is necessary in patients with: - systemic lupus erythematosus or mixed connective tissue disease, due to increased risk of aseptic meningitis (see section 4.8); - congenital disorders of porphyrin metabolism (e.g. acute intermittent porphyria); - gastrointestinal pathologies and chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) (see section 4.8); - history of hypertension and\/or heart failure since, in association with NSAID therapy, water retention and edema have been reported; - renal impairment, as renal function may deteriorate (see sections 4.3 and 4.8); - liver dysfunction (see sections 4.3 and 4.8); - immediately after major surgery; - hay fever, nasal polyps or chronic obstructive respiratory diseases, as there is an increased risk of developing allergic reactions for these patients. These can manifest themselves in the form of asthma attacks (so-called “analgesic asthma”), Quincke's edema or urticaria. - in patients who have already experienced allergic reactions to other substances, as they are at higher risk of developing hypersensitivity reactions even when using NUROFENTEEN. \u003cb\u003eOther NSAIDs\u003c\/b\u003e: The use of NUROFENTEEN should be avoided concomitantly with other NSAIDs, including selective cyclooxygenase-2 inhibitors. \u003cb\u003eMasking of symptoms of underlying infections\u003c\/b\u003e NUROFENTEEN may mask the symptoms of infection, which could delay the initiation of appropriate treatment and therefore worsen the outcome of the infection. This has been observed in community-acquired bacterial pneumonia and bacterial complications of chickenpox. When NUROFENTEEN is administered for the relief of fever or pain related to infection, monitoring of the infection is recommended. In non-hospital settings, the patient should seek medical attention if symptoms persist or worsen. \u003cb\u003eCardiovascular and cerebrovascular effects:\u003c\/b\u003e Clinical studies suggest that the use of ibuprofen, especially at high doses (2400 mg per day), may be associated with a modest increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke). Overall, epidemiological studies do not suggest that low doses of ibuprofen (e.g., ≤ 1200 mg per day) are associated with an increased risk of arterial thrombotic events. Patients with uncontrolled hypertension, congestive heart failure (NYHA class II-III), established ischemic heart disease, peripheral arterial disease and\/or cerebrovascular disease should be treated with ibuprofen only after careful consideration and high doses (2400 mg\/day) should be avoided. Careful consideration must also be exercised before starting long-term treatment for patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidemia, diabetes mellitus, smoking), especially if high doses (2400 mg\/day) of ibuprofen are necessary. \u003cb\u003eGastrointestinal effects\u003c\/b\u003eGastrointestinal bleeding, ulceration and perforation: During treatment with all NSAIDs, at any time, with or without warning symptoms or previous history of serious gastrointestinal events, gastrointestinal bleeding, ulceration and perforation, which may be fatal, have been reported. In the elderly and in patients with a history of ulcer, especially if complicated by haemorrhage or perforation (see section 4.3), the risk of gastrointestinal haemorrhage, ulceration or perforation is higher with increasing doses of NSAIDs. These patients should start treatment with the lowest available dose. The concomitant use of protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients and also for patients concomitantly taking low doses of acetylsalicylic acid or other drugs that may increase the risk of gastrointestinal events (see section 4.5). Patients with a history of gastrointestinal toxicity, particularly the elderly, should report any unusual gastrointestinal symptoms (especially gastrointestinal bleeding) particularly in the initial stages of treatment. Caution should be exercised in patients taking concomitant medications that may increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or antiplatelet agents such as acetylsalicylic acid (see section 4.5). When gastrointestinal bleeding or ulceration occurs in patients taking NUROFENTEEN, treatment should be discontinued. NSAIDs should be administered with caution to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated (see section 4.8). \u003cb\u003eSevere skin reactions\u003c\/b\u003e: Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported very rarely in association with the use of NSAIDs (see section 4.8). Patients appear to be at higher risk in the early stages of therapy: the onset of the reaction occurs in most cases within the first month of treatment. Acute generalized exanthematous pustulosis (PEAG) has been reported in connection with ibuprofen-containing medicinal products. NUROFENTEEN should be discontinued at the first appearance of signs and symptoms of severe skin reactions, such as rash, mucosal lesions or any other sign of hypersensitivity. Chickenpox can exceptionally cause serious infectious complications to the skin and soft tissues. It is advisable to avoid using NUROFENTEEN in case of chickenpox. \u003cb\u003eRespiratory disorders\u003c\/b\u003e: bronchospasm may occur in patients with bronchial asthma or current or previous allergic diseases. \u003cb\u003eOther considerations\u003c\/b\u003e Severe acute hypersensitivity reactions (e.g. anaphylactic shock) are observed very rarely. At the first signs of hypersensitivity reaction after administration\/taking of NUROFENTEEN, therapy should be discontinued. Medical aid measures required based on symptoms must be undertaken by specialized personnel. Ibuprofen, the active ingredient in NUROFENTEEN, can temporarily inhibit the function of platelets (thrombocyte aggregation), therefore it is recommended to carefully monitor patients with coagulation disorders. In case of prolonged administration of NUROFENTEEN, regular monitoring of liver values, renal function and blood counts is required. Prolonged use of any type of pain reliever for headache can make symptoms worse. If this situation occurs or is suspected, the doctor should be consulted and treatment should be suspended. The diagnosis of medication overuse headache (MOH) should be suspected in patients who experience frequent or daily headaches despite or because of the regular use of headache medications. Side effects related to the active ingredient, in particular those relating to the gastrointestinal tract or central nervous system, may be increased by taking NSAIDs in combination with alcohol. \u003cb\u003eRenal disorders\u003c\/b\u003e: in general, the habitual use of analgesics, especially combinations of different analgesic active ingredients, can lead to permanent kidney damage with the risk of onset of renal failure (analgesic nephropathy). \u003cb\u003ePediatric population\u003c\/b\u003e: in dehydrated adolescents there is a risk of impaired renal function. \u003cb\u003eCompromised female fertility\u003c\/b\u003e: see paragraph 4.6. \u003cb\u003eSpecific warnings for this medicine\u003c\/b\u003e: This medicine contains aspartame, a source of phenylalanine, which may be dangerous for people with phenylketonuria.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eINTERACTIONS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cb\u003eIbuprofen should be avoided in association with:\u003c\/b\u003e Acetylsalicylic acid (ASA): Concomitant administration of ibuprofen and acetylsalicylic acid is generally not recommended due to the potential for increased side effects. Other NSAIDs including selective cyclooxygenase-2 inhibitors: avoid concomitant use of two or more NSAIDs, as this may increase the risk of adverse events (see section 4.4). Experimental data suggest that ibuprofen may competitively inhibit the effect of low-dose acetylsalicylic acid on platelet aggregation when the drugs are administered simultaneously. Although there are uncertainties regarding the extrapolation of these data to the clinical situation, the possibility cannot be excluded that long-term regular use of ibuprofen may reduce the cardioprotective effect of acetylsalicylic acid at low doses. No relevant clinical effects are considered likely following occasional use of ibuprofen (see section 5.1). Ibuprofen (like other NSAIDs) should be used with caution in association with: - Corticosteroids: increased risk of gastrointestinal ulceration or bleeding (see section 4.4) - Anticoagulants: NSAIDs may increase the effects of anticoagulants, such as warfarin (see section 4.4) - Phenytoin: concomitant use of NUROFENTEEN with phenytoin-based preparations may increase serum levels of both substances. Correct use of the drugs (administered for a maximum period of 4 days) does not normally require monitoring of serum phenytoin levels. - Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding (see section 4.4). - Antihypertensives (ACE inhibitors, beta-blockers and angiotensin II antagonists) and diuretics: NSAIDs can decrease the effects of these drugs. In some patients with compromised renal function (e.g. dehydrated patients or elderly patients with compromised renal function) co-administration of an ACE inhibitor, a beta-blocker or an angiotensin II antagonist and agents that inhibit the cyclo-oxygenase system may lead to further deterioration of renal function, including possible acute renal failure, which is usually reversible. Therefore, the combination should be administered with caution, especially in elderly patients. Patients should be adequately hydrated and consideration should be given to monitoring renal function after initiation of concomitant therapy and at regular intervals thereafter. Diuretics may increase the risk of nephrotoxicity of NSAIDs, - Cardiac glycosides (Digoxin): NSAIDs may worsen heart failure, reduce GFR and plasma levels of glycosides. Concomitant use of NUROFENTEEN with digoxin preparations may increase serum levels of these medicines. Correct use of the drugs (administered for a maximum period of 4 days) does not normally require monitoring of serum digoxin levels. - Cyclosporine: increased risk of nephrotoxicity - Lithium. There is evidence of the possibility of a potential increase in lithium levels in the blood. Correct use of the drugs (administered for a maximum period of 4 days) does not normally require monitoring of serum lithium levels. - Probenecid and sulfinpyrazone: Medicines containing probenecid or sulfinpyrazone may delay the excretion of ibuprofen. - Potassium-sparing diuretics: concomitant administration of NUROFENTEEN and potassium-sparing diuretics may lead to hyperkalaemia (monitoring of serum potassium is recommended). - Methotrexate. There is evidence of the possibility of an increase in plasma levels of methotrexate. The administration of NUROFENTEEN in the 24 hours before and after the administration of methotrexate may lead to an increase in plasma levels of methotrexate and an increase in its toxic effects. - Zidovudine. There is evidence of an increased risk of haemarthrosis and haematoma in HIV-positive haemophilia patients if treated simultaneously with zidovudine and ibuprofen. - Sulfonylureas: clinical studies have shown interactions between nonsteroidal anti-inflammatory drugs and antidiabetics (sulfonylureas). Although no interactions between ibuprofen and sulfonylureas have been described so far, monitoring of blood glucose values ​​is recommended as a precautionary measure during concomitant intake. - Tacrolimus: possible increased risk of nephrotoxicity when NSAIDs are administered with tacrolimus. - Quinolone antibiotics: data from animal studies indicate that NSAIDs may increase the risk of seizures associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may have an increased risk of developing seizures. - CYP2C9 inhibitors: concomitant administration of ibuprofen and CYP2C9 inhibitors may increase exposure to ibuprofen (CYP2C9 substrate). In a study with voriconazole and fluconazole (CYP2C9 inhibitors), increased exposure to S(+)-ibuprofen by approximately 80% to 100% was observed. Reduction of the ibuprofen dose should be considered when potent CYP2C9 inhibitors are co-administered, particularly when high doses of ibuprofen are administered with voriconazole or fluconazole.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eSIDE EFFECTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eThe list of the following side effects includes all side effects that have been recognized during treatment with ibuprofen, even those observed during prolonged high-dose therapy in patients with rheumatism. The frequencies reported, which extend beyond reports of very rare side effects, refer to short periods of treatment for daily doses up to a maximum of 1200 mg of ibuprofen for oral pharmaceutical forms and up to a maximum of 1800 mg for suppositories. It should be taken into account that the following adverse reactions are predominantly dose-dependent and vary from individual to individual. Adverse reactions associated with the administration of ibuprofen are listed below according to system organ class and frequency. Frequencies are defined as: Very common (≥1\/10); Common (≥1\/100, \u003c1\/10); Uncommon (≥1\/1,000, \u003c1\/100); Rare (≥1\/10,000, \u003c1\/1,000); Very rare (\u003c1\/10,000); Not known (frequency cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. The most often observed adverse reactions are gastrointestinal in nature. Adverse reactions are in most cases dose-dependent. In particular, the risk of gastrointestinal bleeding depends on the dosage and duration of treatment. Peptic ulcers, perforation or gastrointestinal haemorrhage, sometimes fatal, may occur, particularly in the elderly (see section 4.4). Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease have been reported following administration of ibuprofen (see section 4.4). Less frequently, gastritis was observed. Edema, hypertension and heart failure have been reported in association with NSAID treatment. Clinical studies suggest that the use of ibuprofen, especially at high doses (2400 mg per day) may be associated with a slightly increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke) (see section 4.4). Worsening of infection-related inflammation (e.g. development of necrotizing fasciitis) associated with the use of non-steroidal anti-inflammatory drugs has been described. This is probably due to the mechanism of action of non-steroidal anti-inflammatory drugs. If signs of an infection occur or worsen while using NUROFENTEEN, the patient should be advised to seek immediate medical attention to assess whether anti-infective\/antibiotic therapy is required. For prolonged treatments blood counts should be checked regularly. The patient must be explained that he must immediately inform the doctor and stop taking NUROFENTEEN if any symptoms of hypersensitivity reactions occur; this can also happen on first use, in which case immediate medical assistance is required. The patient should be instructed to stop taking the medicine and consult a doctor immediately if severe pain in the upper abdomen or melena or haematemesis occurs.\u003c\/p\u003e\n\u003cp\u003eInfections and infestations - Frequency: Very rare. Adverse reaction: Worsening of inflammation related to infections (e.g. development of necrotizing fasciitis) has been described. In exceptional cases, serious skin infections and soft tissue complications have been found during a chickenpox infection.\u003c\/p\u003e\n\u003cp\u003eBlood and lymphatic system disorders - Frequency: Very rare. Adverse reaction: Hematopoiesis disorders (anaemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). The first manifestations are: fever, sore throat, superficial ulcers of the oral cavity, flu-like symptoms, severe fatigue, nasal and skin bleeding, bruises. In these cases the patient should be advised to discontinue the medicine immediately, to avoid any self-medication medicine containing analgesics or antipyretics and to consult his doctor.\u003c\/p\u003e\n\u003cp\u003ePsychiatric disorders - Frequency: Very rare. Adverse reaction: Psychotic reactions, depression.\u003c\/p\u003e\n\u003cp\u003eImmune system disorders - Adverse reaction: Hypersensitivity reactions manifested by¹:\u003c\/p\u003e\n\u003cp\u003eImmune system disorders - Frequency: Uncommon. Adverse reaction: Urticaria and itching.\u003c\/p\u003e\n\u003cp\u003eImmune system disorders - Frequency: Very rare. Adverse reaction: Severe hypersensitivity reactions. Symptoms may be: swelling of the face, tongue and larynx, dyspnea, tachycardia, hypotension (anaphylaxis, angioedema or severe shock). Asthma exacerbation.\u003c\/p\u003e\n\u003cp\u003eImmune system disorders - Frequency: Not known. Adverse reaction: Respiratory tract reactivity including asthma, bronchospasm and dyspnoea.\u003c\/p\u003e\n\u003cp\u003eNervous system disorders - Frequency: Uncommon. Adverse reaction: Central nervous system disorders such as headache, dizziness, insomnia, agitation, irritability or tiredness.\u003c\/p\u003e\n\u003cp\u003eNervous system disorders - Frequency: Very rare. Adverse reaction: Aseptic meningitis²\u003c\/p\u003e\n\u003cp\u003eEye disorders - Frequency: Uncommon. Adverse reaction: Visual disturbances.\u003c\/p\u003e\n\u003cp\u003eEar and labyrinth disorders - Frequency: Rare. Adverse reaction: Tinnitus.\u003c\/p\u003e\n\u003cp\u003eCardiac disorders - Frequency: Very rare. Adverse reaction: Heart failure, palpitations and edema, myocardial infarction.\u003c\/p\u003e\n\u003cp\u003eVascular disorders - Frequency: Very rare. Adverse reaction: Hypertension, vasculitis.\u003c\/p\u003e\n\u003cp\u003eGastrointestinal disorders - Frequency: Common. Adverse reaction: Gastrointestinal problems, such as abdominal pain, nausea and dyspepsia. Diarrhea, flatulence, constipation, heartburn, vomiting and slight blood loss in the stomach and\/or intestines which in exceptional cases can cause anemia.\u003c\/p\u003e\n\u003cp\u003eGastrointestinal disorders - Frequency: Uncommon. Adverse reaction: Gastrointestinal ulcers, gastrointestinal perforation or bleeding, ulcerative stomatitis, worsening of colitis or Crohn's disease (see section 4.4), gastritis.\u003c\/p\u003e\n\u003cp\u003eGastrointestinal disorders - Frequency: Very rare. Adverse reaction: Esophagitis and formation of membranous narrowings in the intestine (diaphragmatic-like intestinal narrowings), pancreatitis.\u003c\/p\u003e\n\u003cp\u003eHepatobiliary disorders - Frequency: Very rare. Adverse reaction: Liver dysfunction, liver damage, particularly in long-term therapy, liver failure, acute hepatitis.\u003c\/p\u003e\n\u003cp\u003eSkin and subcutaneous tissue disorders - Frequency: Uncommon. Adverse reaction: Various skin rashes.\u003c\/p\u003e\n\u003cp\u003eSkin and subcutaneous tissue disorders - Frequency: Very rare. Adverse reaction: severe forms of skin reactions such as bullous reactions including Stevens-Johnson syndrome, erythema multiforme and toxic epidermal necrolysis, alopecia.\u003c\/p\u003e\n\u003cp\u003eSkin and subcutaneous tissue disorders - Frequency: Not known. Adverse reaction: Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), acute generalized exanthematous pustulosis (PEAG). Photosensitivity reactions.\u003c\/p\u003e\n\u003cp\u003eRenal and urinary disorders - Frequency: Rare. Adverse reaction: Rarely, kidney tissue damage (papillary necrosis) and high concentrations of uric acid in the blood may occur.\u003c\/p\u003e\n\u003cp\u003eRenal and urinary disorders - Frequency: Very rare. Adverse reaction: Formation of edema, particularly in patients with arterial hypertension or renal failure, nephrotic syndrome, interstitial nephritis which may be accompanied by renal failure.\u003c\/p\u003e\n\u003cp\u003eDiagnostic tests - Frequency: Rare. Adverse reaction: Decreased hemoglobin levels.\u003c\/p\u003e\n\u003cp\u003e\u003cb\u003eDescription of some adverse reactions\u003c\/b\u003e \u003csup\u003e1\u003c\/sup\u003e Hypersensitivity reactions have been reported following treatment with ibuprofen. These reactions include a) non-specific allergic reactions and anaphylaxis., b) respiratory tract reactivity including asthma, aggravated asthma, bronchospasm or dyspnea or c) various skin conditions including various skin rashes, pruritus, urticaria, purpura, angioedema and very rarely bullous and exfoliative dermatitis (including toxic epidermal necrolysis, Stevens-Johnson syndrome and erythema multiforme) ² The mechanism The pathogenesis of drug-induced aseptic meningitis is not completely known. However, the data available on aseptic meningitis related to the administration of NSAIDs leads us to think of an immune reaction (due to a temporal relationship with the intake of the medicine and the disappearance of symptoms after discontinuation of treatment). Of note, individual cases of symptoms of aseptic meningitis (such as stiff neck, numbness, headache, nausea, vomiting, fever and disorientation) have been observed during treatment with ibuprofen in patients with autoimmune diseases (such as systemic lupus erythromatosus, mixed connective tissue disease). \u003cb\u003eReporting of suspected adverse reactions\u003c\/b\u003e Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit\/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https:\/\/www.aifa.gov.it\/content\/segnalazioni-reazioni-avverse.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eOVERDOSE\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eIn children, intake of more than 400 mg\/kg can cause symptoms. In adults the dose response effect is not clearly defined in overdose. The half-life in overdose is 1.5-3 hours. \u003cu\u003eSymptoms\u003c\/u\u003e Most patients who have ingested clinically relevant quantities of NSAIDs present exclusively nausea, vomiting, abdominal pain and more rarely diarrhea. Nystagmus, blurred vision, tinnitus, headache and gastrointestinal bleeding may also occur. In more serious cases of poisoning, central nervous system toxicity is observed which manifests itself with vertigo, dizziness, drowsiness, occasionally excitation and disorientation, loss of consciousness or coma. Occasionally patients develop seizures. In cases of severe poisoning, metabolic acidosis may occur. Hyperkalemia, hypothermia and a prolongation of the prothrombin time\/INR may occur, probably caused by interference with the action of coagulation factors present in the circulation. Acute renal failure, liver damage, hypotension, respiratory depression and cyanosis may also occur. In asthmatic subjects, asthma exacerbation may occur. \u003cu\u003eTreatment\u003c\/u\u003e There is no specific antidote available. Treatment should be symptomatic and supportive and should include maintaining a patent airway and monitoring cardiac function and vital signs until the patient is stabilized. Oral administration of activated charcoal or gastric emptying should be considered if the patient presents within 1 hour of ingesting a potentially toxic quantity. If ibuprofen has already been absorbed, alkaline substances should be administered to promote excretion of the acidic ibuprofen in the urine. Seizures should be treated with intravenous diazepam or lorazepam if they are frequent or prolonged. Administer bronchodilators in case of asthma. For more information contact your local poison center.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003ePREGNANCY AND BREASTFEEDING\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cu\u003ePregnancy\u003c\/u\u003e Inhibition of prostaglandin synthesis can negatively affect the pregnant woman and\/or embryonic\/fetal development. Data obtained from epidemiological studies suggest an increased risk of miscarriage, cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor during early pregnancy. The absolute risk of cardiac malformations increased from less than 1% to approximately 1.5%. The risk may increase with the dose and duration of therapy. In animals, the administration of prostaglandin synthesis inhibitors has been shown to cause an increase in pre- and post-implantation loss and embryo-fetal mortality. Furthermore, an increased incidence of various malformations, including cardiovascular malformations, has been reported in animals to which prostaglandin synthesis inhibitors were administered during the organogenetic period. Animal studies have shown reproductive toxicity (see section 5.3). During the first and second trimester of pregnancy, ibuprofen should not be administered unless clearly necessary. When used by women in the process of conceiving or during the first and second trimester of pregnancy, the dose and duration of treatment should be as low and as short as possible, respectively. During the third trimester of pregnancy, all inhibitors of prostaglandin synthesis can expose the fetus to: - cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension); - renal dysfunction which may progress to renal failure with oligohydramniosis; the mother and newborn, at the end of pregnancy, to: - possible prolongation of bleeding time, an anti-aggregating effect which can occur even at very low doses; - inhibition of uterine contractions resulting in delayed or prolonged labor. Consequently, ibuprofen is contraindicated during the third trimester of pregnancy. \u003cu\u003eBreastfeeding\u003c\/u\u003e Ibuprofen and its metabolites can pass in low concentrations into breast milk. No dangerous effects for newborns are known to date, therefore for short treatments with the recommended dose for pain and fever, interruption of breastfeeding is generally not necessary. \u003cu\u003eFertility\u003c\/u\u003e There is evidence that medicinal products that inhibit the synthesis of cyclooxygenase\/prostaglandins can cause impairment of female fertility due to their effect on ovulation. This effect is reversible after discontinuation of treatment.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eEFFECTS ON DRIVING ABILITY\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eFor short periods of treatment, NUROFENTEEN does not or negligibly alter the ability to drive and use machinery.\u003c\/p\u003e","brand":"Reckitt Benckiser","offers":[{"title":"Default Title","offer_id":51730211438919,"sku":"035677145","price":10.14,"currency_code":"EUR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0564\/4989\/2467\/files\/reckitt-benckiser-h-it-spa-nurofenteen-200-mg-12-compresse-orosolubili-limone-farmacia-dottor-tili-1213791026.jpg?v=1767164709"},{"product_id":"nurofen-200-mg-12-compresse-rivestite","title":"Nurofen 200 mg 12 coated tablets","description":"\u003cp\u003e\u003cstrong\u003eINDICATIONS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003ePain of various kinds: headache, toothache, neuralgia, muscular and osteoarticular pain, menstrual pain. Adjuvant in the symptomatic treatment of feverish and flu states. Nurofen is indicated in adults and adolescents over 12 years of age\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eACTIVE INGREDIENTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e200 mg coated tablets: each tablet contains 200 mg of ibuprofen 400 mg coated tablets: each tablet contains 400 mg of ibuprofen Excipients with known effects: Each 200 mg coated tablet contains: - 116.1 mg of sucrose, equivalent to approximately 0.34 mmol - 17.34 mg of sodium, equivalent to approximately 0.75 mmol Each 400 mg coated tablet contains: - 232.2 mg, equivalent to approximately 0.68 mmol - 34.69 mg sodium, equivalent to approximately 1.51 mmol. For the full list of excipients, see section 6.1.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eEXCIPIENTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cb\u003eNurofen 200 mg coated tablets\u003c\/b\u003e Croscarmellose sodium, \u003cb\u003esodium\u003c\/b\u003e lauryl sulfate, \u003cb\u003esodium\u003c\/b\u003e citrate, stearic acid, colloidal anhydrous silica, carmellose \u003cb\u003esodium\u003c\/b\u003e, talc, dried atomized gum arabic, \u003cb\u003esucrose\u003c\/b\u003e, titanium dioxide, macrogol 6000, ink (shellac, black iron oxide E172, propylene glycol E1520). \u003cb\u003eNurofen 400 mg coated tablets\u003c\/b\u003e Croscarmellose \u003cb\u003esodium\u003c\/b\u003e, \u003cb\u003esodium\u003c\/b\u003e lauryl sulfate, \u003cb\u003esodium\u003c\/b\u003e citrate, stearic acid, colloidal anhydrous silica, carmellose \u003cb\u003esodium\u003c\/b\u003e, talc, dried atomized gum arabic, \u003cb\u003esucrose\u003c\/b\u003e, titanium dioxide, macrogol 6000, ink (shellac, red iron oxide (E 172), propylene glycol (E1520), ammonium hydroxide (E527), simethicone).\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eCONTRAINDICATIONS AND SIDE EFFECTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eHypersensitivity to the active substance or to any of the excipients, listed in paragraph 6.1. Patients who have previously experienced hypersensitivity reactions (e.g. bronchospasm, asthma, rhinitis, angioedema or urticaria) following the use of ibuprofen, acetylsalicylic acid, or other non-steroidal anti-inflammatory products (NSAIDs). Patients with severe hepatic or renal impairment (see section 4.4). Severe heart failure (NYHA class IV) Patients with a history of gastrointestinal bleeding or perforation, related to previous NSAID therapy. Patients with current or previous recurrent peptic ulcers\/haemorrhages (two or more distinct episodes of proven ulceration or bleeding). During the last trimester of pregnancy (see section 4.6). Children under 12 years old. Before or after cardiac surgery.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eDOSAGE\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cu\u003eDosage \u003c\/u\u003e Only for a short period of treatment. Undesirable effects can be minimized by using the lowest effective dose for the shortest possible treatment duration needed to control symptoms (see section 4.4). If symptoms persist or worsen after a short period of treatment, consult your doctor. If the use of the medicine is necessary for more than 3 days in adolescents, or in the case of worsening of symptoms, the doctor should be consulted. \u003cb\u003e \u003cu\u003eNUROFEN 200 mg coated tablets\u003c\/u\u003e \u003c\/b\u003e \u003cb\u003e Pediatric population:\u003c\/b\u003e Do not administer to children under 12 years of age.\u003cb\u003eAdults and adolescents over 12 years old\u003c\/b\u003e: 1-2 tablets, 2-3 times a day. The interval between doses should not be less than 4 hours. Do not exceed a dose of 1200 mg (6 tablets) in 24 hours. \u003cb\u003eElderly\u003c\/b\u003e: No changes to the dosage schedule are required. \u003cb\u003e \u003cu\u003eNUROFEN 400 mg coated tablets\u003c\/u\u003e \u003c\/b\u003e \u003cb\u003ePediatric population:\u003c\/b\u003e Do not administer to children under 12 years of age.\u003cb\u003eAdults and adolescents over 12 years old\u003c\/b\u003e One tablet 2-3 times a day. The interval between doses should not be less than 4 hours. Do not exceed a dose of 1200 mg (3 tablets) in 24 hours. \u003cb\u003eElderly:\u003c\/b\u003e No changes to the dosage schedule are required. \u003cu\u003eMethod of administration \u003c\/u\u003e Oral use Patients with gastric sensitivity problems are advised to take Nurofen on a full stomach.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eCONSERVATION\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eNurofen 400 mg coated tablets: store at a temperature not exceeding 30°C.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eWARNINGS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eCaution is required in patients with coagulation defects. Side effects can be minimized by using the lowest effective dose for the shortest possible treatment duration needed to control symptoms (see gastrointestinal and cardiovascular risks below). \u003cb\u003eElderly\u003c\/b\u003e: Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which may be fatal (see section 4.2). \u003cb\u003ePediatric population\u003c\/b\u003e: in dehydrated adolescents there is a risk of impaired renal function. \u003cb\u003eRespiratory disorders\u003c\/b\u003e: bronchospasm may occur in patients with bronchial asthma or current or previous allergic diseases. \u003cb\u003eOther NSAIDs\u003c\/b\u003e: The use of Nurofen should be avoided concomitantly with other NSAIDs, including selective cyclooxygenase-2 inhibitors. (see paragraph 4.5) \u003cb\u003eSLE and mixed connective tissue disease\u003c\/b\u003e Systemic lupus erythematosus and with mixed connective tissue disease due to increased risk of aseptic meningitis (see section 4.8); \u003cb\u003eCardiovascular and cerebrovascular effects\u003c\/b\u003e: caution is required (discuss with your doctor or pharmacist) before starting treatment in patients with a positive history of hypertension and\/or heart failure since fluid retention, hypertension and edema have been reported in association with treatment with NSAIDs. Clinical studies suggest that the use of ibuprofen, especially at high doses (2400 mg\/day), may be associated with a modest increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke). In general, epidemiological studies do not suggest that low doses of ibuprofen (e.g. ≤ 1200 mg\/day) are associated with an increased risk of arterial thrombotic events. Patients with uncontrolled hypertension, congestive heart failure (NYHA class II-III), established ischemic heart disease, peripheral arterial disease and\/or cerebrovascular disease should be treated with ibuprofen only after careful consideration and high doses (2400 mg\/day) should be avoided. Careful consideration must also be exercised before starting long-term treatment for patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidemia, diabetes mellitus, cigarette smoking habit), especially if high doses (2400 mg\/day) of ibuprofen are necessary. \u003cb\u003eLiver or kidney function:\u003c\/b\u003e • renal failure, as renal function may be compromised (see sections 4.3 and 4.8). In general, the habitual use of analgesics, especially combinations of different analgesic active ingredients, can lead to permanent kidney damage with the risk of the onset of renal failure (analgesic nephropathy). • liver dysfunction (see sections 4.3 and 4.8). Particular caution should be taken when treating patients with reduced hepatic or renal function. In such patients it is advisable to resort to periodic monitoring of clinical and laboratory parameters, especially in case of prolonged treatment. \u003cb\u003eCompromised female fertility\u003c\/b\u003e: Administration of Nurofen should be avoided in women planning pregnancy (see section 4.6). \u003cb\u003eGastrointestinal safety\u003c\/b\u003e: NSAIDs should be administered with caution to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated (see section 4.8). Gastrointestinal haemorrhage, ulceration and perforation, which may be fatal, have been reported during treatment with all NSAIDs at any time, with or without warning symptoms or previous history of serious gastrointestinal events. In the elderly and in patients with a history of ulcer, especially if complicated by haemorrhage or perforation (see section 4.3), the risk of gastrointestinal haemorrhage, ulceration or perforation is higher with increased doses of NSAIDs. These patients should start treatment with the lowest available dose. The concomitant use of protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients and also for patients taking low doses of acetylsalicylic acid or other drugs that may increase the risk of gastrointestinal events (see section 4.5). Patients with a history of gastrointestinal toxicity, particularly the elderly, should report any unusual gastrointestinal symptoms (especially gastrointestinal haemorrhage) particularly in the initial stages of treatment. Caution should be exercised in patients taking concomitant medications that may increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or antiplatelet agents such as acetylsalicylic acid (see section 4.5). When gastrointestinal bleeding or ulceration occurs in patients taking Nurofen, treatment should be discontinued. \u003cb\u003eSevere skin reactions:\u003c\/b\u003e Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported rarely in association with the use of NSAIDs (see section 4.8). Patients appear to be at higher risk in the early stages of therapy: the onset of the reaction occurs in most cases within the first month of treatment. Acute generalized exanthematous pustulosis (PEAG) has been reported in connection with ibuprofen-containing medicinal products. Ibuprofen should be discontinued at the first appearance of signs and symptoms of severe skin reactions, such as rash, mucosal lesions or any other sign of hypersensitivity. \u003cb\u003eMasking of symptoms of underlying infections\u003c\/b\u003e: Nurofen may mask the symptoms of infection, which may delay the initiation of appropriate treatment and therefore worsen the outcome of the infection. This has been observed in community-acquired bacterial pneumonia and bacterial complications of chickenpox. When Nurofen is given for the relief of fever or pain related to infection, monitoring of the infection is advised. In non-hospital settings, the patient should seek medical attention if symptoms persist or worsen. \u003cb\u003eOther:\u003c\/b\u003e during prolonged treatments with analgesic medicinal products at doses higher than those indicated, headaches may occur which must not be treated with higher doses of the product. Alcohol consumption should be avoided as it can intensify the side effects of NSAIDs, especially those affecting the gastrointestinal tract or central nervous system. At the first signs of hypersensitivity reaction after administration of ibuprofen, treatment should be discontinued. Medically assisted measures must be initiated by specialized medical personnel, in line with the symptoms. Acid ibuprofen can cause a prolongation of the bleeding time by reversibly inhibiting the aggregation of platelets. \u003cb\u003eImportant information about some excipients\u003c\/b\u003e \u003cu\u003eNurofen\u003c\/u\u003e contains sucrose: patients suffering from rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase isomaltase insufficiency should not take this medicine. \u003cu\u003eNurofen 200 mg coated tablets\u003c\/u\u003e contains sodium: this medicine contains less than 1 mmol (23 mg) sodium per tablet (17.34 mg), i.e. essentially 'sodium-free' and just over 1 mmol (23 mg) sodium per 2 tablets (34.68 mg), equivalent to 1.73% of the maximum daily intake recommended by the WHO which corresponds to 2 g sodium for an adult. \u003cu\u003eNurofen 400 mg coated tablets contain sodium\u003c\/u\u003e: This medicine contains 34.69 mg sodium per tablet, equivalent to 1.73% of the WHO recommended maximum daily intake of 2 g sodium for an adult.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eINTERACTIONS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eIbuprofen should be avoided in association with: - Acetylsalicylic acid: concomitant administration of ibuprofen and acetylsalicylic acid is generally not recommended due to the potential for increased side effects (see section 4.4). Experimental data suggest that ibuprofen can competitively inhibit the effect of low-dose acetylsalicylic acid on platelet aggregation when the two drugs are administered simultaneously. Although there are uncertainties regarding the extrapolation of these data to the clinical situation, the possibility cannot be excluded that regular, long-term use of ibuprofen may reduce the cardioprotective effect of acetylsalicylic acid at low doses. No relevant clinical effects are considered likely following occasional use of ibuprofen (see section 5.1). - Other NSAIDs including selective cyclooxygenase-2 inhibitors: the concomitant use of two or more NSAIDs should be avoided as they may increase the risk of adverse reactions affecting the gastrointestinal tract (see section 4.4). Ibuprofen (like other NSAIDs) should be used with caution in association with: - Corticosteroids: increased risk of gastrointestinal ulceration or haemorrhage (see section 4.4) - Anticoagulants: NSAIDs may increase the effects of anticoagulants, such as warfarin (see section 4.4) - Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal haemorrhage (see section 4.4). - Antihypertensives (ACE inhibitors and Angiotensin II Antagonists), diuretics and beta blockers: NSAIDs can reduce the effect of diuretics and other antihypertensive drugs. In some patients with compromised renal function (e.g. dehydrated patients or elderly patients with compromised renal function) co-administration of an ACE inhibitor or an angiotensin II antagonist and agents that inhibit the cyclo-oxygenase system may lead to further deterioration of renal function, including possible acute renal failure, which is usually reversible. These interactions should be considered in patients taking a coxib (such as Nurofen) concomitantly with ACE inhibitors or angiotensin II antagonists. Therefore, the combination should be administered with caution, especially in elderly patients. Patients should be adequately hydrated and consideration should be given to monitoring renal function after initiation of concomitant therapy and at regular intervals thereafter. Diuretics may increase the risk of NSAID nephrotoxicity. - Cardiac glycosides: NSAIDs can worsen heart failure, reduce GFR (glomerular filtration rate) and increase plasma levels of glycosides. - Lithium. There are demonstrations of the possibility of a potential increase in lithium levels in the blood, with the possibility of reaching the toxic threshold. If this combination is necessary, monitor lithium levels in order to adapt the lithium dosage during simultaneous treatment with ibuprofen. - Methotrexate. There is evidence of the possibility of an increase in plasma levels of methotrexate. - Cyclosporins: increase the risk of nephrotoxicity. - Mifepristone: NSAIDs should not be taken for 8-12 days after administration of Mifepristone as NSAIDs may reduce the effects of Mifepristone. - Tacrolimus: possible increased risk of nephrotoxicity when NSAIDs are administered with Tacrolimus. - Zidovudine: increased risk of haematological toxicity when NSAIDs are administered with Zidovudine. There is evidence of an increased risk of haemarthrosis and haematoma in HIV-positive haemophilia patients if treated simultaneously with zidovudine and ibuprofen. - Antibiotics quinolones: Data from animal studies indicate that NSAIDs may increase the risk of seizures associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may have an increased risk of developing seizures. - Alcohol, bisphosphonates and pentoxifylline: can potentiate gastrointestinal side effects and the risk of bleeding and ulcers. - Baclofen: high toxicity of baclofen.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eSIDE EFFECTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eThe list of the following side effects includes side effects that have been observed during treatment with ibuprofen at self-medication doses (up to a maximum of 1200mg per day). In case of chronic conditions, additional side effects may occur during long-term treatment. The side effects associated with the administration of ibuprofen are listed below according to system organ classification and frequency. \u003ci\u003eFor the frequency of occurrence of side effects, the following expressions are used:\u003c\/i\u003e \u003ci\u003eVery common (\u003c\/i\u003e≥ \u003ci\u003e1\/10)\u003c\/i\u003e; \u003ci\u003eMunicipality (\u003c\/i\u003e≥ \u003ci\u003e1\/100, \u0026lt;1\/10)\u003c\/i\u003e; \u003ci\u003eUncommon (\u003c\/i\u003e≥ \u003ci\u003e1\/1000, \u0026lt;1\/100)\u003c\/i\u003e; \u003ci\u003eRare (\u003c\/i\u003e≥ \u003ci\u003e1\/10.000, \u0026lt;1\/1000)\u003c\/i\u003e; \u003ci\u003eVery rare (\u003c1\/10,000)\u003c\/i\u003e; \u003ci\u003eNot known (frequency cannot be estimated from the available data)\u003c\/i\u003e. \u003ci\u003eWithin each frequency grouping, undesirable effects are presented in order of decreasing seriousness.\u003c\/i\u003e\u003c\/p\u003e\n\u003cp\u003eBlood and lymphatic system disorders - Frequency: Very Rare. Adverse Reaction: Hematopoietic disorders¹\u003c\/p\u003e\n\u003cp\u003eImmune system disorders - Frequency: Uncommon. Adverse Reaction: Hypersensitivity reactions including urticaria and pruritus²\u003c\/p\u003e\n\u003cp\u003eImmune system disorders - Frequency: Very Rare. Adverse Reaction: Severe hypersensitivity reactions including swelling of the face, tongue and throat, dyspnoea, tachycardia, hypotension (anaphylaxis, angioedema or severe shock)²\u003c\/p\u003e\n\u003cp\u003eNervous system disorders - Frequency: Uncommon. Adverse Reaction: Headache, dizziness.\u003c\/p\u003e\n\u003cp\u003eNervous system disorders - Frequency: Rare. Adverse Reaction: Cerebrovascular accident9.\u003c\/p\u003e\n\u003cp\u003eNervous system disorders - Frequency: Very rare. Adverse Reaction: Aseptic meningitis³\u003c\/p\u003e\n\u003cp\u003eEye disorders - Frequency: Very Rare. Adverse Reaction: Visual disturbances.\u003c\/p\u003e\n\u003cp\u003eCardiac disorders - Frequency: Very rare. Adverse Reaction: Heart failure and edema4.\u003c\/p\u003e\n\u003cp\u003eVascular disorders - Frequency: Very rare. Adverse Reaction: Hypertension4.\u003c\/p\u003e\n\u003cp\u003eRespiratory, thoracic and mediastinal disorders - Frequency: Not known. Adverse Reaction: Respiratory tract reactivity including asthma, worsening of asthma, bronchospasm or dyspnea.\u003c\/p\u003e\n\u003cp\u003eGastrointestinal disorders - Frequency: Uncommon. Adverse Reaction: Dyspepsia, abdominal pain and nausea5.\u003c\/p\u003e\n\u003cp\u003eGastrointestinal disorders - Frequency: Rare. Adverse Reaction: Diarrhoea, flatulence, constipation and vomiting.\u003c\/p\u003e\n\u003cp\u003eGastrointestinal disorders - Frequency: Very rare. Adverse Reaction: Peptic ulcers, gastrointestinal perforation or hemorrhage, melena, hematemesis6, ulcerative stomatitis, gastritis.\u003c\/p\u003e\n\u003cp\u003eGastrointestinal disorders - Frequency: Not known. Adverse Reaction: Exacerbation of colitis and Crohn's disease7, pancreatitis.\u003c\/p\u003e\n\u003cp\u003eHepatobiliary disorders - Frequency: Rare. Adverse Reaction: Hepatotoxicity\u003c\/p\u003e\n\u003cp\u003eHepatobiliary disorders - Frequency: Very rare. Adverse Reaction: Liver disorders, especially following long-term treatment, hepatitis, jaundice.\u003c\/p\u003e\n\u003cp\u003eSkin and subcutaneous tissue disorders - Frequency: Uncommon. Adverse Reaction: Skin rashes².\u003c\/p\u003e\n\u003cp\u003eSkin and subcutaneous tissue disorders - Frequency: Very rare. Adverse Reaction: Erythema multiforme, bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis.²\u003c\/p\u003e\n\u003cp\u003eSkin and subcutaneous tissue disorders - Frequency: Not known. Adverse Reaction: Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), acute generalized exanthematous pustulosis (PEAG), photosensitivity reactions\u003c\/p\u003e\n\u003cp\u003eRenal and urinary disorders - Frequency: Very rare. Adverse Reaction: Acute renal failure8, hematuria, nephritis, nephrotic syndrome9.\u003c\/p\u003e\n\u003cp\u003eDiagnostic tests - Frequency: Rare. Adverse Reaction: Increased transaminases, increased alkaline phosphatase, decreased hematocrit, prolonged bleeding time, decreased blood calcium, increased uric acid.\u003c\/p\u003e\n\u003cp\u003eDiagnostic tests - Frequency: Very rare. Adverse Reaction: Decreased hemoglobin level in the blood.\u003c\/p\u003e\n\u003cp\u003e\u003cb\u003eDescription of some side effects\u003c\/b\u003e \u003csup\u003e1\u003c\/sup\u003e Examples include anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). The first manifestations are: fever, sore throat, superficial ulcers of the oral cavity, flu-like symptoms, severe fatigue, bruises and unexplained bleeding. ² Hypersensitivity reactions: these reactions may include a) non-specific allergic reactions and anaphylaxis, b) respiratory tract reactivity including asthma, worsening of asthma, bronchospasm or dyspnoea or c) various skin conditions such as various skin rashes, pruritus, urticaria, purpura, angioedema and very rarely bullous and exfoliative dermatitis including toxic epidermal necrolysis, Stevens-Johnson syndrome and erythema multiforme. ³ The pathogenesis of drug-induced aseptic meningitis is not completely understood. However, the data available on aseptic meningitis related to the administration of NSAIDs leads us to think of an immune hypersensitivity reaction (due to a temporary relationship with the intake of the medicine and the disappearance of symptoms after discontinuation of treatment). Of note, individual cases of aseptic meningitis symptoms (such as stiff neck, headache, nausea, vomiting, fever and disorientation) have been observed during treatment with ibuprofen in patients with autoimmune disorders (such as systemic lupus erythematosus, mixed connective tissue disease). \u003csup\u003e4\u003c\/sup\u003e Clinical studies suggest that the use of ibuprofen, especially at high doses (2400 mg\/day) may be associated with a modest increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke) (see section 4.4) \u003csup\u003e5\u003c\/sup\u003e The most commonly observed adverse reactions are gastrointestinal in nature. \u003csup\u003e6\u003c\/sup\u003e sometimes fatal, particularly in the elderly \u003csup\u003e7\u003c\/sup\u003e see paragraph 4.4 \u003csup\u003e8\u003c\/sup\u003e particularly following long-term treatment, associated with increased serum urea concentrations. Decreased urea excretion and edema. Also includes papillary necrosis \u003csup\u003e9\u003c\/sup\u003e reported as an effect of NSAID class \u003cb\u003eReporting of suspected adverse reactions\u003c\/b\u003e Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit\/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at: https:\/\/www.aifa.gov.it\/content\/segnalazioni-reazioniavverse.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eOVERDOSE\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cu\u003eToxicity \u003c\/u\u003e Signs and symptoms of toxicity were generally not observed at doses below 100 mg\/kg in children or adults. However, in some cases supportive treatment may be necessary. Children have been observed to exhibit signs and symptoms of toxicity after ingesting ibuprofen at doses of 400 mg\/kg or greater. \u003cu\u003eSymptoms \u003c\/u\u003e Most patients who have ingested significant amounts of ibuprofen will experience symptoms within 4 to 6 hours. The most commonly reported overdose symptoms include: nausea, vomiting, abdominal pain, lethargy, and drowsiness. Central nervous system (CNS) effects include headache, tinnitus, dizziness, seizures, and loss of consciousness. Nystagmus, metabolic acidosis, hypothermia, renal effects, gastrointestinal bleeding, coma, apnea, diarrhea and depression of the CNS and respiratory system, blurring of vision have also been reported rarely. Disorientation, arousal, fainting and cardiovascular toxicity including hypotension, bradycardia and tachycardia have been reported. In cases of significant overdose, renal failure and liver damage are possible. In cases of severe poisoning, metabolic acidosis and a prolongation of the prothrombin time\/INR may occur, probably caused by interference with the action of coagulation factors present in the circulation. In asthmatic subjects, asthma exacerbation may occur. \u003cu\u003eTreatment \u003c\/u\u003e There is no specific antidote for ibuprofen overdose. In case of overdose, symptomatic and supportive treatment is therefore indicated and must include maintaining a patent airway and monitoring cardiac function and vital signs until the patient is stabilised. Particular attention is due to the control of blood pressure, acid-base balance and any gastrointestinal bleeding. Administration of activated charcoal should be considered within one hour of ingesting a potentially toxic quantity. Alternatively, in adults, gastric lavage should be considered within one hour of ingestion of a potentially life-threatening overdose. Adequate diuresis must be ensured and renal and hepatic functions must be closely monitored. The patient must remain under observation for at least four hours following ingestion of a potentially toxic amount of drug. Any occurrence of frequent or prolonged convulsions should be treated with intravenous diazepam. If ibuprofen has already been absorbed, alkaline substances should be administered to promote excretion of the acidic ibuprofen in the urine. Administer bronchodilators in case of asthma. Depending on the patient's clinical condition, other support measures may be necessary. For more information, contact your local poison control center.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003ePREGNANCY AND BREASTFEEDING\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cu\u003ePregnancy\u003c\/u\u003e Inhibition of prostaglandin synthesis can negatively affect the pregnant woman and\/or embryo\/foetal development. Data obtained from epidemiological studies suggest an increased risk of miscarriage, cardiac malformation and gastroschisis after the use of a prostaglandin synthesis inhibitor during early pregnancy. The absolute risk of cardiac malformations increased from less than 1% to approximately 1.5%. The risk is thought to increase with the dose and duration of therapy. In animals, the administration of prostaglandin synthesis inhibitors has been shown to cause an increase in pre- and post-implantation loss and embryo-foetal mortality. Furthermore, an increased incidence of various malformations, including cardiovascular malformations, has been reported in animals to which prostaglandin synthesis inhibitors were administered during the organogenetic period. From the 20th\u003csup\u003ea\u003c\/sup\u003e week of pregnancy onwards, the use of ibuprofen could cause oligohydramnios resulting from fetal renal dysfunction. This condition may be experienced shortly after starting treatment and is usually reversible upon discontinuation of treatment. Additionally, cases of constriction of the ductus arteriosus have been reported following treatment in the second trimester, most of which resolved after treatment was discontinued. Therefore, during the first and second trimester of pregnancy ibuprofen should not be administered unless strictly necessary. If ibuprofen is used by a woman planning pregnancy, or during the first and second trimester of pregnancy, the lowest possible dose should be used for the shortest possible time. Following exposure to ibuprofen for several days from the 20th\u003csup\u003ea\u003c\/sup\u003e week of gestation onwards, antenatal monitoring for oligohydramnios and ductus arteriosus constriction should be considered. In case of oligohydramnios or constriction of the ductus arteriosus, treatment with ibuprofen should be discontinued. During the third trimester of pregnancy, all inhibitors of prostaglandin synthesis can expose the fetus to: - cardiopulmonary toxicity (premature constriction\/closure of the ductus arteriosus and pulmonary hypertension); - renal dysfunction (see above); the mother and the newborn, at the end of pregnancy, to: - possible prolongation of bleeding time, an anti-aggregating effect which can occur even at very low doses; - inhibition of uterine contractions resulting in delayed or prolonged labor. Consequently, Nurofen is contraindicated during the third trimester of pregnancy (see sections 4.3 and 5.3). \u003cu\u003eBreastfeeding \u003c\/u\u003e Ibuprofen and its metabolites can pass in low concentrations into breast milk. No dangerous effects for newborns are known to date, therefore for short treatments with the recommended dose for pain and fever, interruption of breastfeeding is generally not necessary. \u003cu\u003eFertility \u003c\/u\u003e There is evidence that medicinal products that inhibit the synthesis of cyclooxygenase\/prostaglandins can cause a weakening of female fertility by affecting ovulation. This effect is reversible after discontinuation of treatment. The administration of Nurofen should be suspended in women who have fertility problems or who are undergoing fertility investigations.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eEFFECTS ON DRIVING ABILITY\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eFor short periods of treatment, Nurofen has no or negligible influence on the ability to drive and use machinery.\u003c\/p\u003e","brand":"Reckitt Benckiser","offers":[{"title":"Default Title","offer_id":51730211930439,"sku":"025634015","price":6.23,"currency_code":"EUR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0564\/4989\/2467\/files\/reckitt-benckiser-h-it-spa-nurofen-200-mg-12-compresse-rivestite-farmacia-dottor-tili-1213791012.jpg?v=1767155787"}],"url":"https:\/\/www.dottortili.com\/en\/collections\/nurofen.oembed","provider":"Farmacia Dottor Tili","version":"1.0","type":"link"}