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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: Ibuprofen is indicated for symptomatic treatment of pain and inflammation in arthritic diseases (e.g. rheumatoid arthritis) degenerative arthritic conditions (e.g. osteoarthritis), and in painful swelling and inflammation after soft tissue injuries. It is also indicated for the relief of mild to moderate pain, e.g.…
Verbatim from this product's MHRA label. Tap a section to expand.
4). The treating physician decides on the duration of treatment. In rheumatic diseases the use of ibuprofen can be required for a longer period. The ibuprofen dose depends on the patient’s age and body weight. The maximum single dose for adults should not exceed 800 mg of ibuprofen.
Posology Mild to moderate pain and fever Adults and adolescents ≥40 kg body weight (12 years and above): 200-400 mg given as a single dose or 3-4 times a day with an interval of 6 hours as required. The dosage in migraine headache should be: 400 mg given as a single dose, if necessary 400 mg with intervals up to 6 hours.
The maximum daily dose should not exceed 1200 mg.
Paediatric population Children ≥20 kg body weight (6-11 years):
Children 20-29 kg (6-9 years): 200 mg 1-3 times a day with intervals of 6 hours as required. The maximum daily dose should not exceed 600 mg. Children 30-90 kg (10-11 years): 200 mg 1-4 times a day with intervals of 6 hours as required.
The maximum daily dose should not exceed 800 mg. Ibuprofen is contraindicated in children below 20 kg body weight or younger than 6 years of age. 3) Primary dysmenorrhoea Adults and adolescents ≥40 kg body weight (12 years of age and above): 200-400 mg 1-3 times a day, with an interval up to 6 hours, as needed.
The maximum daily dose should not exceed 1200 mg.
Rheumatic diseases Adults:
The recommended dose is 1200-1800 mg daily in divided doses. Maintenance doses of 600 mg-1200 mg daily may be effective in some patients. In acute and severe conditions the dose may be (temporarily) increased to a maximum of 2400 mg in 3 or 4 divided doses.
Adolescents from 15 to 17 years of age:
The recommended dose should be adjusted by weight: 20 mg/kg to a maximum of 40 mg/kg body weight daily (max 2400 mg daily) in 3 to 4 divided doses. 4). If treatment is considered necessary, the lowest dose for the shortest duration necessary to control symptoms should be used.
Treatment should be reviewed at regular intervals and discontinued if no benefit is seen or intolerance occurs. Impaired renal function In patients with mild or moderate reduction of renal function, the dose should be kept as low as possible for the shortest duration necessary to control symptoms and renal function monitored.
With the following adverse drug reactions, it must be accounted for that they are predominantly dose- dependent and vary interindividually. The most commonly observed adverse events are gastrointestinal in nature. 4). 4) have been reported following administration.
Less frequently, gastritis has been observed. 4). Oedema, hypertension, and cardiac failure, have been reported in association with NSAID treatment. Assessment of adverse reactions is normally based on the following occurrence 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) Not known (cannot be estimated from the available data).
System organ class Frequency Adverse reaction Blood and lymphatic system disorders Very rare Haematopoietic disorders (anaemia, leucopoenia, thrombocytopenia, pancytopenia, agranulocytosis, neutropenia). The first symptoms or signs may include: fever, sore throat, surface mouth ulcers, flu-like symptoms, severe fatigue, nasal and skin bleeding Uncommon Hypersensitivity reactions such as urticaria, pruritus, purpura and exanthema as well as asthma attacks (sometimes with hypotension) Rare Lupus erythematosus syndrome Immune system disorders Very rare Severe hypersensitivity reactions.
4) Renal and urinary disorders Very rare Acute renal failure Not known Ureteric colic, dysuria Renal tubular acidosis* Metabolism and Nutrition Disorders Not known Decreased Appetite Hypokalaemia* General disorders and administration site conditions Not known Malaise Investigations Rare Increase of blood urea nitrogen, serum transaminases and alkaline phosphatase, decrease in haemoglobin and haematocrit values, inhibition of platelet aggregation, Prolonged bleeding time, decrease of serum calcium, increase in serum uric acid 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.
5). 2, and GI and cardiovascular risks below). Patients treated with NSAIDs long term should undergo regular medical supervision to monitor for adverse events. Ibuprofen should only be administered under strict consideration of the benefit- risk ratio in the following conditions: - Systemic Lupus Erythematosus (SLE) or mixed connective tissue diseases.
g. 2) Renal Effects: Ibuprofen may cause the retention of sodium, potassium and fluid in patients who have not previously suffered from renal disorders because of its effect on renal perfusion. This may cause oedema or even lead to cardiac insufficiency or hypertension in predisposed patients.
As with other NSAIDs, the prolonged administration of ibuprofen to animals has resulted in renal papillary necrosis and other pathological renal changes. In humans, there have been reports of acute interstitial nephritis with haematuria, proteinuria and occasionally nephrotic syndrome.
Cases of renal toxicity have also been observed in patients in whom prostaglandins play a compensatory role in the maintenance of renal perfusion. In these patients, administration of NSAIDs 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 suffering this reaction are those with renal dysfunction, heart failure, hepatic dysfunction, those taking diuretics and ACE inhibitors and the elderly. Discontinuation of NSAID treatment is generally 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.
8).
Cardiovascular and cerebrovascular effects:
g. 2).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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3). Impaired liver function In patients with mild or moderate reduction of liver function the dose should be kept as low as possible for the shortest duration necessary to control symptoms and liver function monitored. 3). Method of administration The tablet should be swallowed with a glass of water preferably after a meal.
It is recommended, that patients with a sensitive stomach take ibuprofen during a meal.
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.
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 trial data suggest that use of ibuprofen, particularly at a high dose (2400mg 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. ≤1200mg daily) is associated with an increased risk of arterial thrombotic events. 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 Tablet. 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.
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.
NSAIDs should be given with care to patients with a history of […]