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Nurofen Max Strength Migraine Pain 684mg Caplets (pack of 12) |
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Ibuprofen Lysine 684 mg/tablet (equivalent to 400 mg ibuprofen).
Coated tablet.
A white, film-coated, capsule-shaped tablet, printed with an identifying logo in black on one face
For the relief of headache and migraine.
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For oral administration and short-term use only.
During short-term use, if symptoms persist or worsen the patient should be advised to consult a doctor.
Adults and children over 12 years: Initial dose, one tablet taken with water, then, if necessary, one caplet every four hours. Do not exceed three caplets in any 24 hours. Not for use by children under 12 years of age Elderly: No special dosage modifications are required. (see Section 4.4).
The minimum effective dose should be used for the shortest time necessary to relieve symptoms. If the product is required for more than 10 days, or if the symptoms worsen the patient should consult a doctor
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Patients with a known hypersensitivity to ibuprofen or any other constituent of the medicinal product.
Patients with a history of bronchospasm, asthma, rhinitis, or urticaria associated with aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs).
Patients with a history of, or existing gastrointestinal ulceration/perforation or bleeding, including that associated with NSAIDs (see Section 4.4).
Patients with severe hepatic failure, severe renal failure or severe heart failure. See also section 4.4.
Use with concomitant NSAIDs, including cyclo-oxygenase-2 specific inhibitors – increased risk of adverse reactions (see section 4.5).
During the last trimester of pregnancy as there is a risk of premature closure of the foetal ductus arteriosus with possible persistent pulmonary hypertension. The onset of labour may be delayed and the duration increased with an increased bleeding tendency in both mother and child (see Section 4.6).
Severe heart failure.
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Ibuprofen (like other NSAIDs) should not be used in combination with:
• Aspirin unless low-dose aspirin (not above 75mg daily) has been advised by a doctor as this may increase the risk of adverse reactions (see Section 4.3).
• Other NSAIDs as these may increase the risk of adverse effects (see Section 4.3)
Ibuprofen should be used with caution in combination with:
• Corticosteroids as these may increase the risk of adverse reactions, especially of the gastrointestinal tract. (see Section 4.3)
• Antihypertensives and diuretics since NSAIDs may diminish the effects of these drugs.
• Anticoagulants. There is limited evidence of enhancement of oral anticoagulant effects.
• Lithium. There is evidence for potential increase in plasma levels of lithium.
• Methotrexate. There is evidence for the potential increase in plasma levels of methotrexate.
• Zidovudine. There is evidence of an increased risk of haemarthroses and haematoma in HIV (+) haemophiliacs receiving concurrent treatment with zidovudine and ibuprofen
Hypersensitivity reactions have been reported and these may consist of
• non-specific allergic reactions and anaphylaxis
• respiratory tract reactivity e.g. asthma, aggravated asthma, bronchospasm, dyspnoea
• various skin reactions e.g. pruritus, urticaria, angioedema and more rarely exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme)
The list of the following adverse effects relates to those experienced with ibuprofen at OTC doses, for short-term use. In the treatment of chronic conditions, under long-term treatment, additional adverse effects may occur.
Gastrointestinal Uncommon: abdominal pain, dyspepsia and nausea. Disorders Rare: diarrhoea, flatulence, constipation and vomiting
Very rare: Peptic ulcer, perforation or gastrointestinal haemorrhage, sometimes fatal, particularly in the elderly (see section 4.4) Exacerbation of ulcerative colitis and Crohn's disease (See section 4.4)
Nervous System Uncommon: Headache
Kidney Very rare: Decrease of urea excretion and oedema can occur. Also, acute renal failure. Papillary necrosis, especially in long-term use, and increased serum urea concentrations have been reported
Liver Very rare: liver disorders.
Blood Very rare: haematopoietic disorders (anaemia, leucopenia, thrombocytopenia, pancytopenia, agranulocytosis). First signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion, unexplained bleeding and bruising
Skin Very rare: severe forms of skin reactions such as erythema multiforme and epidermal necrolysis can occur. Uncommon: Various skin rashes.
Immune System Very rare: In patients with existing auto-immune disorders (such as systemic lupus erythematosus, mixed connective tissue disease) during treatment with ibuprofen, single cases of symptoms of aseptic meningitis, such as stiff neck, headache, nausea, vomiting, fever or disorientation have been observed
Hypersensitivity Uncommon: Hypersensitivity reactions with urticaria and Reactions pruritus.
Very rare severe hypersensitivity reactions. Symptoms could be: facial, tongue and larynx swelling, dyspnoea, tachycardia, hypotension, (anaphylaxis, angioedema or severe shock).
Exacerbation of asthma and bronchospasm.
Oedema, hypertension, and cardiac failure, have been reported in association with NSAID treatment
Clinical trial and epidemiological data suggest that use of ibuprofen (particularly at high doses 2400mg daily) and in long-term treatment may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke) (see section 4.4).
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