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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 migraine-headaches, backache, dental pain, neuralgia and period pains as well as rheumatic or muscular pains, and pain of non-serious arthritic conditions. Ibuprofen relieves pain and reduces inflammation and temperature as well as relieving headaches and other types of pain. It also relieves cold…
Verbatim from this product's MHRA label. Tap a section to expand.
For oral administration and short-term use only. 4). During short-term use, if symptoms persist or worsen the patient should be advised to consult a doctor.
Adults 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. If in adults the product is required for more than 10 days, or if the symptoms worsen the patient should consult a doctor.
Children and Adolescents between 12 and 18 years:
Take 1 or 2 tablets with water, up to three times a day as required.
Adults:
Take 1 or 2 tablets with water, up to three times a day as required. Leave at least four hours between doses. Do not take more than 6 tablets in any 24 hour period. Not for use by children under 12 years of age.
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 list of the following adverse events relates to those experienced with ibuprofen at OTC doses (maximum 1200mg per day) for short-term use.
In the treatment of chronic conditions, under long-term treatment, additions adverse effects may occur. 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.
4). System Organ Class Frequency Adverse Event Blood and Lymphatic System Disorders 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.
Uncommon Hypersensitivity reactions consisting of1:
Urticaria and pruritus Immune System Disorders Very rare Severe hypersensitivity reactions. Symptoms could be facial, tongue and laryngeal swelling, dyspnoea, tachycardia, hypotension (anaphylaxis, angioedema or severe shock). Not Known Respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm or dyspnoea.
Nervous System Disorders Uncommon Very rare Headache Aseptic meningitis 2. Cardiac Disorders Not Known Kounis syndrome, Cardiac failure and oedema Vascular Disorders Not Known Hypertension 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.
2 and GI and cardiovascular risks below). The elderly have an increased frequency of adverse reactions to NSAIDs especially gastro-intestinal bleeding and perforation which may be fatal. 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).
Respiratory:
Bronchospasm may be precipitated in patients suffering from, or with a previous history of, bronchial asthma or allergic disease.
Other NSAIDs:
The use of ibuprofen with concomitant NSAIDs including cyclooxygenase -2 selective inhibitors should be avoided. 5) SLE and mixed connective tissue disease: Systemic lupus erythematosus as well as those with mixed connective tissue disease - increased risk of aseptic meningitis.
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.
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.
Hypersensitivity to Ibuprofen or any of the excipients of 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). Last trimester of pregnancy.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Ibuprofen in United Kingdom.
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4). Hepatobiliary Disorders Very rare Liver disorders Uncommon Various skin rashesSkin 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 Very rare Acute renal failure, papillary necrosis, especially in long- term use, associated with increased serum urea and oedema.
Renal and Urinary Disorders Not Known Renal insufficiency, Renal tubular acidosis3 Investigations Very rare Decreased haemoglobin levels Metabolism and Nutrition Disorders Not Known Hypokalaemia3 Description of Selected Adverse Reactions: 1 Hypersensitivity reactions have been reported following treatment with ibuprofen.
These may consist of (a) non-specific allergic reactions and anaphylaxis, (b) respiratory tract activity comprising asthma, aggravated asthma, bronchospasm, dyspnoea or (c) assorted skin disorders, including rashes of various types pruritus, urticaria, purpura, angioedema and more rarely exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme).
2 The 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, in patients with existing auto-immune disorders (such as systemic lupus erythematosus, mixed connective tissue disease).
3 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 by searching 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 200 mg 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.
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.
Gastrointestinal:
NSAIDs should be given with care to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn’s disease) as these conditions may be exacerbated. 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 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 the 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 ulceration or bleeding, such as oral corticosteroids, anti- coagulants such as warfarin, selective serotonin – reuptake inhibitors or anti-platelet agents such as aspirin.
5) When GI bleeding or ulceration occurs in patients receiving ibuprofen, the treatment should be withdrawn. 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, monitoring of infection is advised. In non-hospital settings, the patient should consult a doctor if symptoms persist or worsen.
Excipients:
Advice for patients with sugar-related disorders: Contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. Contains lactose.
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactase malabsorption should not take this medicine.
Advice for patients on a controlled sodium diet:
This medicine contains […]