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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: Relief of mild to moderate pain; rheumatoid arthritis; ankylosing spondylitis; osteoarthritis; sero-negative arthropathies; pain relief of peri-articular disorders; pain relief of soft tissue injuries.
Verbatim from this product's MHRA label. Tap a section to expand.
For oral administration. Swallow the tablets with a drink of water, preferably with or after food. 4).
Adults:
Take one tablet to start, followed by one tablet every 6 hours if necessary. Do not take more than 4 tablets in any 24 hour period.
Elderly:
The elderly are at increased risk of the serious consequences of adverse reactions. If an NSAID is considered necessary, the lowest effective dose should be used and for the shortest possible duration. The patient should be monitored regularly for GI bleeding during NSAID therapy.
Children:
Not recommended. 4).
4). Blood and lymphatic system disorders: leucopenia, thrombocytopenia, pancytopenia, neutropenia, agranulocytosis, aplastic anaemia and haemolytic anaemia. Immune system disorders: hypersensitivity reactions have been reported following treatment with NSAIDs.
These may consist of (a) non-specific allergic reactions and anaphylaxis, (b) respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm or dyspnoea, or (c) assorted skin disorders, including rashes of various types, pruritus, urticaria, purpura, angiodema and more rarely exfoliative and bullous dermatoses (including Stevens- Johnson syndrome, toxic epidermal necrolysis and erythema multiforme).
Psychiatric disorders: insomnia, anxiety, depression, confusion, hallucinations. Nervous system disorders: optic neuritis, headaches, paraesthesia, dizziness and drowsiness. Eye disorders: visual disturbances, toxic optic neuropathy.
Ear and labyrinth disorders: hearing impaired, tinnitus and vertigo. Cardiac disorders and vascular disorders: oedema, hypertension and cardiac failure have been reported in association with NSAID treatment. 4). Gastrointestinal disorders: the most commonly observed adverse events are gastro- intestinal in nature.
4). 4) have been reported following administration. Less frequently, gastritis has been observed. Gastrointestinal perforation has been rarely reported with ibuprofen use. Pancreatitis has also been reported very rarely. Hepatobiliary disorders: abnormal liver function, hepatic failure, hepatitis and jaundice.
Skin and subcutaneous tissue disorders:
Severe cutaneous adverse reactions (SCARs) (Including Erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis(very rare). Photosensitivity reactions – frequency unknown.
2, and GI and cardiovascular risks below). Masking of symptoms of underlying infection 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, monitoring of infection is advised. In non-hospital settings, the patient should consult a doctor if symptoms persist or worsen.
5). 2). Paediatric population There is a risk of renal impairment in dehydrated children and adolescents.
Respiratory disorders:
Caution is required if administered to patients suffering from, or with a previous history of bronchial asthma, since NSAIDs have been reported to cause bronchospasm in such patients.
Cardiovascular, Renal and Hepatic Impairment:
The administration of an NSAID may cause a dose dependent reduction in prostaglandin formation and precipitate renal failure. Patients at greatest risk of this reaction are those with impaired renal function, cardiac impairment, liver dysfunction, those taking diuretics and the elderly.
3). Cardiovascular and cerebrovascular effects Appropriate monitoring and advice are required for patients with a history of hypertension and/or mild to moderate congestive heart failure as fluid retention and oedema have been reported in association with NSAID therapy.
Clinical studies suggest that use of ibuprofen, particularly at a high dose (2400mg/day) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). g. ≤ 1200mg/day) is associated with an increased risk of arterial thrombotic events.
Contraindicated in those with known hypersensitivity to ibuprofen or to any of the other constituents. g. asthma, rhinitis, angioedema or urticaria). 4). 6) History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy.
Ibuprofen should not be given to patients with conditions involving an increased tendency to bleeding.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Not known:
Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome). Acute generalised exanthematous pustulosis (AGEP). Renal and urinary disorders: impaired renal function and nephrotoxicity in various forms, including interstitial nephritis, nephrotic syndrome, papillary necrosis.
Acute renal failure – very rare. Renal tubular acidosis*, ureteric colic, dysuria – frequency unknown. General disorders and administration site conditions: malaise, fatigue.
Metabolism and nutrition disorders:
Hypokalaemia*, decreased appetite– frequency unknown. *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.
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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
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.
g. hypertension, hyperlipidaemia, diabetes mellitus, smoking), particularly if high doses of ibuprofen (2400 mg/day) are required. 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.
Renal effects Caution should be used when initiating treatment with ibuprofen in patients with considerable dehydration. As with other NSAIDs, long-term administration of ibuprofen has resulted in renal papillary necrosis and other renal pathologic changes.
Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. In these patients administration of an NSAID may cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which may precipitate overt renal decompensation.
Patients at greatest risk of this reaction are those with impaired renal function, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors and the elderly. Discontinuation of NSAID therapy is usually followed by recovery to the pre- treatment state.
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.
Gastrointestinal bleeding, ulceration and perforation:
GI bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at any time 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.
g. 5). 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.
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