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IBUPROFEN INFIRST 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 rheumatic or muscular pain, pain of non-serious arthritic conditions, 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. Do not chew. 4).
Children under 12 years:
Not recommended. Adults, the elderly and children over 12 years If in adolescents (age range ≥ 12 years to 18 ≤ years) this medicinal product is required for more than 3 days, or if symptoms worsen a doctor should be consulted. The patient over 18 years old should consult a doctor if symptoms persist or worsen, or if the product is required for more than 10 days.
Take one or two capsules (200 mg – 400 mg), 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.
The most commonly observed adverse events are gastrointestinal in nature. g. g. 4). 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.
Treatment related adverse reactions are listed below by MedDRA system organ class and frequency. The following convention has been utilised for the classification of frequency: very common ≥ 1/10; common ≥ 1/100 to < 1/10, uncommon ≥ 1/1,000 to < 1/100; rare ≥ 1/10,000 to < 1/1,000; very rare < 1/10,000 and not known (cannot be estimated from the available data).
MedDRA Standard System Organ Class Adverse Reactions Frequency Blood and lymphatic system disorders 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.
Very rare Immune system disorders Hypersensitivity reactions with urticaria and pruritus. Uncommon Severe hypersensitivity reactions. Symptoms could be: facial, tongue and laryngeal swelling, dyspnoea, tachycardia, hypotension, (anaphylaxis, angioedema or severe shock).
Exacerbation of asthma and bronchospasm. Very rare Metabolism and Nutrition Disorders Decreased Appetite Not known Hypokalaemia1 Not known Headache UncommonNervous system disorders Aseptic meningitis2 Very rare Cardiac disorders Cardiac failure, hypertension and oedema Not known Kounis syndrome Not known Abdominal pain, nausea and dyspepsia.
UncommonGastrointestinal disorders Diarrhoea, flatulence, constipation and vomiting. Rare Peptic ulcer, perforation or gastrointestinal haemorrhage, melaena, haematemesis, sometimes fatal, particularly in the elderly. Ulcerative stomatitis, gastritis.
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 GI 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).
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.
There is a risk of renal impairment in dehydrated adolescents. 8). 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.
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).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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4). Very rare Hepatobiliary disorders Liver disorders. Very rare Various skin rashes. Uncommon Severe cutaneous adverse reactions (SCARs) (including Erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis) Very rare Skin and subcutaneous tissue disorders Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome).
Acute generalised exanthematous pustulosis (AGEP) Not known Photosensitivity reactions Not known Renal and urinary disorders Acute renal failure, papillary necrosis, especially in long-term use, associated with increased serum urea and oedema.
Very rare Ureteric colic, dysuria Not known Renal tubular acidosis1 Not known 1 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.
4). 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.
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 hypersensitivity 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.
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).
Masking of symptoms of underlying infections Ibuprofen infirst 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 infirst 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. Patients with rare hereditary problems of fructose intolerance should not take this medicine because of the presence of sorbitol.
The label will include:
Read the enclosed leaflet before taking this product. Do not take if you: • have ever had a stomach ulcer, perforation or bleeding • are allergic to ibuprofen or any other ingredients of the product, aspirin or other related painkillers • are taking other NSAID painkillers or aspirin with a daily dose above 75mg • are in the last 3 months of pregnancy.
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