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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: For the relief of mild to moderate pain including rheumatic or muscular pain, backache, headache, dental pain, migraine, neuralgia, dysmenorrhoea, feverishness and for the relief of 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. Not to be used for children under 12 years of age. 4). The patient should consult a doctor if symptoms persist or worsen, or if the product is required for more than 10 days. 200-400 mg to be taken up to three times a day as required.
Leave at least four hours between doses and do not take more than 1200 mg in any 24 hour period. Method of administration For oral administration. To be taken preferably with or after food, with a glass of water. Ibuprofen tablets should be swallowed whole and not chewed, broken, crushed or sucked on to avoid oral discomfort and throat irritation.
Adverse events which have been associated with Ibuprofen are given below, listed by system organ class and frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare(≥1/10,000 to <1/1000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
Within each frequency grouping, adverse events are presented in order of decreasing seriousness. The adverse events observed most often are gastrointestinal in nature. Adverse events are mostly dose-dependent, in particular the risk of occurrence of gastrointestinal bleeding is dependent on the dosage range and duration of treatment.
• 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. System Organ Class Frequency Adverse Event Blood and Lymphatic System Disorders Very rare: Haematopoietic disorders (anaemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis).
First signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion, unexplained bleeding and bruising. Immune System Disorders Uncommon Very rare Hypersensitivity reactions consisting of1: Urticaria and pruritus Severe hypersensitivity reactions.
Symptoms could be facial, tongue and Not Known laryngeal swelling, dyspnoea, tachycardia, hypotension (anaphylaxis, angioedema or severe shock). Respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm or dyspnoea.
Nervous System Disorders Uncommon Very rare Headache Aseptic meningitis2 Cardiac Disorders Not Known Cardiac failure and oedema Vascular Disorders Not Known Hypertension Gastrointestinal Disorders Uncommon Rare Very rare Not known Abdominal pain, nausea, dyspepsia Diarrhoea, flatulence, constipation and vomiting Peptic ulcer, perforation or gastrointestinal haemorrhage, melaena, haematemesis, sometimes fatal, particularly in the elderly.
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.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Respiratory:
Bronchospasm may be precipitated in patients suffering from or with a previous history of bronchial asthma or allergic disease. 5). 8).
Renal:
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). Clinical trial and epidemiological data suggest that use of ibuprofen, particularly at high doses (2400 mg daily) and in long-term treatment may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke).
g. ≤ 1200 mg daily) is associated with an increased risk of myocardial infarction. Patients with uncontrolled hypertension, congestive heart failure (NYHA IIIII), 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 200mg film-coated tablets.
1. 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. 6).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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4). Hepatobiliary Disorders Very rare Liver disorders Skin and Subcutaneous Tissue Disorders Uncommon Very rare Not known Various skin rashes Severe cutaneous adverse reactions (SCARs) (including Erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis) Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome) Acute generalised exanthematous pustulosis (AGEP) Photosensitivity reactions Metabolism and Nutrition Disorders Not known Not known Decreased Appetite Hypokalaemia* Renal and Urinary Disorders Very rare Not known Not known Acute renal failure, papillary necrosis, especially in long-term use, associated with increased serum urea and oedema.
g. asthma, aggravated asthma, bronchospasm or dyspnoea o Assorted skin disorders, including rashes of various types, pruritus, urticaria, purpura, angioedema and, more rarely, exfoliative and bullous dermatoses (including toxic epidermal necrolysis and erythema multiforme).
2The pathogenic mechanism of drug-Induced aseptic meningitis is not fully understood. However, the available data on NSAID-related aseptic meningitis points to a hypersensitivity reaction (due to a temporal relationship with drug intake, and disappearance of symptoms after drug discontinuation).
Of note, single cases of symptoms of aseptic meningitis (such as stiff neck, headache, nausea, vomiting, fever or disorientation) have been observed during treatment with ibuprofen, inpatients with existing auto-immune disorders (such as systemic lupus erythematosus, mixed connective tissue disease).
*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 events 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.
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.
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.
Caution should be advised in patients receiving concomitant medications which could increase the risk of gastro-toxicity or bleeding, such as oral corticosteroids, or anticoagulants such as warfarin or selective serotonin re- uptake inhibitors or anti- platelet agents such as aspirin (See section