{"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","url":"https:\/\/www.dottortili.com\/en-eu\/products\/nurofen-fever-and-pain-children-100-mg-5-ml-150-ml-suspension-without-sugar-taste-orange-with-syringe","provider":"Farmacia Dottor Tili","version":"1.0","type":"link"}