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IBUPROFEN is a brand name for Ibuprofen. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Adults, elderly and children over 12 years Rheumatic or muscular pain, backache, neuralgia, migraine, headache, dental pain, dysmenorrhoea, feverishness, symptoms of colds and influenza.
Verbatim from this product's MHRA label. Tap a section to expand.
For oral administration and short-term use only. 4). The patient should consult a doctor if symptoms persist or worsen, or if the product is required for more than 10 days. Initial dose two tablets (400mg) taken with water, then if necessary, one or two tablets (200 – 400mg) every 4 hours.
Leave at least four hours between doses and do not take more than six tablets (1200mg) in any 24 hour period. Children under 12 years Not suitable for children under 12 years. If this medicinal product is required for more than 3 days in children and adolescents between the age of 12 to 18 years or if symptoms worsen a doctor should be consulted.
4)
g. g. pruritus, urticaria, angioedema and more rarely exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme) The following list of 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.
Hypersensitivity reactions:
Uncommon: Hypersensitivity reactions with urticaria and pruritus.
Very rare:
Severe hypersensitivity reactions. Symptoms could be: facial, tongue and laryngeal swelling, dyspnoea, tachycardia, hypotension, (anaphylaxis, angioedema or severe shock). Exacerbation of asthma and bronchospasm.
Gastrointestinal:
The most commonly-observed adverse events are gastrointestinal in nature.
Uncommon:
Abdominal pain, nausea, dyspepsia.
Rare:
Diarrhoea, flatulence, constipation and vomiting.
Very rare:
Peptic ulcer, perforation or gastrointestinal haemorrhage, melaena, haematemesis, sometimes fatal, particularly in the elderly. Ulcerative stomatitis, gastritis. 4).
Nervous System:
Uncommon: Headache.
Very rare:
Aseptic meningitis – single cases have been reported very rarely.
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see GI and cardiovascular risks below). The elderly have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal.
Respiratory:
Bronchospasm may be precipitated in patients suffering from or with a previous history of bronchial asthma or allergic disease. 5). 8). 8). There is a risk of renal impairment in dehydrated children and adolescents. Renal tubular acidosis and hypokalaemia may occur following acute overdose and in patients taking ibuprofen products over long periods at high doses (typically greater than 4 weeks), including doses exceeding the recommended daily dose.
8).
Cardiovascular and cerebrovascular effects:
Caution (discussion with doctor or pharmacist) is required prior to starting treatment in patients with a history of hypertension and/or heart failure as fluid retention, hypertension and oedema have been reported in association with NSAID therapy.
Cases of Kounis syndrome have been reported in patients treated with ibuprofen. Kounis syndrome has been defined as cardiovascular symptoms secondary to an allergic or hypersensitive reaction associated with constriction of coronary arteries and potentially leading to myocardial infarction.
Clinical studies suggest that use of ibuprofen, particularly at a high dose (2400 mg/day) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). g. ≤ 1200 mg/day) is associated with an increased risk of arterial thrombotic events.
Patients with uncontrolled hypertension, congestive heart failure (NYHA II-III), established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with ibuprofen after careful consideration and high doses (2400 mg/day) should be avoided.
Hypersensitivity to ibuprofen or any of the excipients in the product. g. asthma, rhinitis, angioedema, or urticaria), in response to aspirin or other non-steroidal anti- inflammatory drugs. Active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding).
History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy. 4). 6). Contains sucrose: patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Hepatic:
Very rare: Liver disorders.
Haematological:
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.
4).
Cardiovascular and cerebrovascular:
Oedema, hypertension, and cardiac failure have been reported in association with NSAID treatment. 4).
Skin and subcutaneous tissue disorders:
Very rare: Severe cutaneous adverse reactions (SCARs) (including Erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis) Not known: Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome) Acute generalised exanthematous pustulosis (AGEP) Photosensitivity reactions - frequency unknown Metabolism and Nutrition Disorders: Not Known: Decreased appetite Not Known: Hypokalaemia* Renal and urinary disorders: Very rare: Acute renal failure, papillary necrosis, especially in long-term use, associated with increased serum urea and oedema.
Not Known:
Ureteric colic, dysuria Not Known: Renal tubular acidosis* Description of Selective Adverse Reactions *Renal tubular acidosis and hypokalaemia have been reported in the post-marketing setting typically following prolonged use of the ibuprofen component at higher than recommended doses.
Cardiac Disorders:
Not Known: Kounis syndrome Reporting of suspected adverse reactions. Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
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g. hypertension, hyperlipidaemia, diabetes mellitus, smoking), particularly if high doses of ibuprofen (2400 mg/day) are required.
Impaired female fertility:
There is limited evidence that drugs which inhibit cyclo-oxygenase/prostaglandin synthesis may cause impairment of female fertility by an effect on ovulation. This is reversible upon withdrawal of treatment. 8). GI bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at anytime during treatment, with or without warning symptoms or a previous history of serious GI events.
3), and in the elderly. These patients should commence treatment on the lowest dose available. Patients with a history of GI toxicity, particularly when elderly, should report any unusual abdominal symptoms (especially GI bleeding) particularly in the initial stages of treatment.
5). When GI bleeding or ulceration occurs in patients receiving ibuprofen, the treatment should be withdrawn. 8). Most of these reactions occurred within the first month. If signs and symptoms suggestive of these reactions appear ibuprofen should be withdrawn immediately and an alternative treatment considered (as appropriate).
The label will include:
Read the enclosed leaflet before taking this product. Do not take: • If you have (or have had two or more episodes of) a stomach ulcer, perforation or bleeding • If you are allergic to ibuprofen or any other ingredients of the product, aspirin or other related painkillers • If you are taking other NSAID painkillers, or aspirin with a daily dose above 75 mg Speak to a pharmacist or your doctor before taking: • If you have or have had asthma, diabetes, high cholesterol, high blood pressure, a stroke, heart, liver, kidney or bowel problems • If you are a smoker • If you are pregnant If your symptoms persist or worsen, consult your doctor.
Masking of symptoms of underlying infections ibuprofen can mask symptoms of infection, which may lead to delayed initiation of appropriate treatment and thereby worsening the outcome of the infection. This has been observed in bacterial community acquired pneumonia and bacterial complications to varicella.
When ibuprofen is administered for fever or pain relief in relation to infection, […]