Nurofen Fever and Pain 200mg/5ml oral suspension strawberry flavour sugar free 100ml

In compliance with article 118 "authorization of advertising to the public" of the legislative decree of 24 April 2006, number 219

INDICATIONS

Symptomatic treatment of fever and mild or moderate pain.

CONTRAINDICATIONS

• 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).

WARNINGS AND PRECAUTIONS FOR USE

Side 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 liquid maltitol, 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 sodium for doses up to 12 ml, i.e. essentially "sodium-free". This medicine contains approximately 27.6 mg of sodium 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 propylene glycol (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 (fromwheat starch present in the orange flavour). This medicine is considered <> 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.

INTERACTIONS

Ibuprofen should be avoided in association with: • 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). • Other NSAIDs including selective cyclooxygenase-2 inhibitors: avoid the simultaneous use of two or more analgesics, antipyretics, non-steroidal anti-inflammatory drugs: increased risk of side effects (see section 4.4). Ibuprofen should be used with caution in combination with: • 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.

SIDE EFFECTS

The 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, <1/10); Uncommon (≥1/1,000, <1/100); Rare (≥1/10,000, <1/1,000); Very rare (<1/10,000); Not known (frequency cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Classification by systems and organs | Frequency | Adverse reaction

Infections and infestations | Rare | Cystitis, rhinitis

Very rare | 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.

Pathologies of the blood and lymphatic system | Very rare | Hematopoiesis disorders ¹

Immune system disorders | Uncommon | Hypersensitivity reactions manifested by urticaria and itching²

Very rare | Severe hypersensitivity reactions including swelling of the face, tongue and larynx, dyspnoea, tachycardia, hypotension (anaphylaxis, angioedema or severe shock).

Metabolism and nutrition disorders | Not known | Fluid retention and decreased appetite³.

Psychiatric disorders | Not known | Irritability

Rare | Depression, insomnia, difficulty concentrating, emotional lability, visual and auditory disturbances.

Nervous system disorders | Uncommon | Headache, dizziness, drowsiness, convulsions.

Very rare | Aseptic meningitis⁴

Rare | Cerebrovascular hemorrhage

Eye diseases | Rare | Dry eyes

Ear and labyrinth disorders | Not known | Tinnitus

Cardiac disorders | Not known | Heart failure and edema⁵.

Rare | Palpitations

Vascular pathologies | Not known | Hypertension⁵ and shock

Respiratory, thoracic and mediastinal disorders | Not known | Respiratory tract reactivity including asthma, laryngeal obstruction, bronchospasm or apnea, dyspnea.

Gastrointestinal disorders | Uncommon | Abdominal pain, nausea and dyspepsia⁶.

Rare | Diarrhoea, flatulence, dry mouth, constipation and vomiting.

Very rare | Peptic ulcer, gastrointestinal perforation or bleeding, melena and hematemesis⁷. Mouth ulcerations and gastritis.

Not known | Exacerbation of colitis and Crohn's disease⁸, pancreatitis, duodenitis, esophagitis.

Hepatobiliary disorders | Very rare | Liver dysfunction, hepatitis, jaundice, hepatorenal syndrome, hepatic necrosis, hepatic failure.

Skin and subcutaneous tissue disorders | Uncommon | Various skin rashes²

Very rare | Bullous reactions including Stevens-Johnson syndrome, erythema multiforme and toxic epidermal necrolysis².

Rare | Exfoliative dermatitis, alopecia, photosensitivity reactions.

Not known | Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), acute generalized exanthematous pustulosis (PEAG).

Renal and urinary disorders | Rare | Tubular necrosis, glomerular nephritis, polyuria, hematuria.

Very rare | Acute renal failure⁹

Diagnostic tests | Rare | Decreased hematocrit levels

Very rare | Decreased hemoglobin levels

Description of some adverse reactions ¹ 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). ^4. 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). ⁵ 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. ⁶ The most commonly observed adverse events are gastrointestinal in nature. Gastric discomfort can be reduced by taking the medicine on a full stomach. ⁷ Peptic ulcers, gastrointestinal perforation or hemorrhage, melena, and sometimes fatal hematemesis may occur. ⁸ Exacerbation of colitis and Crohn's disease (see section 4.4). ⁹ Acute renal failure especially in case of long-term therapy, associated with increased serum urea levels and edema. Papillary necrosis may occur. Reporting of suspected adverse reactions 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.