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UNICHEM EXTRA STRENGTH 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 rheumatic, muscular, dental and period pains and pain in backache, neuralgia, migraine and headache, and for the symptomatic relief of colds, flu and feverishness.
Verbatim from this product's MHRA label. Tap a section to expand.
For oral administration and short-term use only. 4).
Adults, the elderly and children and adolescents between 12 and 18 years:
If in children and adolescents this medicinal product is required for more than 3 days, or if symptoms worsen a doctor should be consulted. Adults should consult a doctor if symptoms persist or worsen, or if the product is required for more than 10 days.
Children and adolescents between 12 and 18 years:
One tablet up to three times as day as required.
Adults:
One tablet up to three times as day as required. Leave at least four hours between doses and do not take more than 3 tablets in any 24 hour period. To be taken preferably after food.
Children under 12 years:
Not to be given to children under 12 years of age.
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.
Metabolisism and Nutrition Disorders:
Not known: Decreased appetite.
Not known:
Hypokalaemia* Renal: Very rare: Acute renal failure, papillary necrosis, especially in long-term use, associated with increased serum urea and oedema.
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) 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: Cases of Kounis syndrome have been reported in patients treated with Cuprofen Maximum Strength Tablets. 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.
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, relating 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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Not known:
Ureteric colic, dysuria Not known: Renal tubular acidosis* 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.
Skin and subcutaneous tissue disorders:
Uncommon: Various skin rashes Very rare: Severe cutaneous adverse reactions (SCARs) including Stevens- Johnson Syndrome, erythema multiforme, exfoliative dermatitis and toxic epidermal necrolysis. 4).
Cardiovascular and Cerebrovascular:
Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment. 4). Not known - Kounis syndrome Description of Selected 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.
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.
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 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. 8). Most of these reactions occurred within the first month. If signs and suggestive of these reactions appear, ibuprofen should be withdrawn immediately, and an alternative treatment considered (as appropriate).
Masking of symptoms of underlying infections This medicinal product 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 this medicine is administered for pain or fever in relation to infection, monitoring of infection is advised. In non-hospital settings, the patient should consult a doctor if symptoms persist or worsen. Excipients - Lactose - Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this product.
- Sodium – this […]