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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 its analgesic and anti-inflammatory effects in the treatment of rheumatoid arthritis (including juvenile rheumatoid arthritis or Still's disease), ankylosing spondylitis, osteoarthritis and other non-rheumatoid (seronegative) arthropathies. In the treatment of non-articular rheumatic…
Verbatim from this product's MHRA label. Tap a section to expand.
4).
Adults and children over 12 years of age :
The recommended dosage of ibuprofen is 1200-1800 mg daily in divided doses. Some patients can be maintained on 600-1200 mg daily. In severe or acute conditions, it can be advantageous to increase the dosage until the acute phase is brought under control, provided that the total daily dose does not exceed 2400 mg in divided doses.
In Juvenile Rheumatoid Arthritis, up to 40 mg/kg of body weight daily in divided doses may be taken. Tablets are not suitable for children under the age of 12 years.
Elderly:
The elderly are at increased risk of serious consequences of adverse reactions. If an NSAID is considered necessary, the lowest effective dose should be used and for the shortest possible duration. The patient should be monitored regularly for GI bleeding during NSAID therapy.
If renal or hepatic function is impaired, dosage should be assessed individually. 3 – Contraindications) Hepatic impairment: For patients with mild to moderate hepatic impairment (see section
With the following adverse drug reactions, it must be accounted for that they are predominantly dose- dependent and vary inter individually. The most commonly observed adverse events are gastrointestinal in nature. 4). 4) have been reported following administration.
Less frequently, gastritis duodenal ulcer, gastric ulcer and gastrointestinal perforation has been observed. 4). Oedema, hypertension, and cardiac failure have been reported in association with NSAID treatment.
Immune system disorders:
Hypersensitivity reactions have been reported following treatment with NSAIDs. These may consist of (a) non-specific allergic reaction and anaphylaxis, (b) respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm or dyspnoea, or (c) assorted skin disorders, including rashes of various types, pruritus, urticaria, purpura, angioedema and very rarely, erythema multiforme, bullous dermatoses (including Stevens-Johnson syndrome and toxic epidermal necrolysis).
4). Exacerbation of infection-related inflammations coinciding with the use of NSAIDs has been described. If signs of an infection occur or get worse during use of Ibuprofen the patient is therefore recommended to go to a doctor without delay.
Skin and subcutaneous tissue disorders:
In exceptional cases, severe skin infections and soft-tissue complications may occur during a varicella infection (see also "Infections and infestations"). The following adverse reactions possibly related to ibuprofen and displayed by MedDRA frequency convention and system organ classification.
Frequency groupings are classified according to the subsequent conventions. 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).
3-Contraindications). For oral administration. It is recommended that patients with sensitive stomachs take ibuprofen with food. If taken shortly after eating, the onset of action of ibuprofen may be delayed. To be taken preferably with or after food, with plenty of fluid.
Ibuprofen tablets should be swallowed whole and not chewed, broken, crushed or sucked on to avoid oral discomfort and throat irritation. 4). 4. g. 4). 6) - significant dehydration (caused by vomiting, diarrhoea or insufficient fluid intake) - cerebrovascular or other active bleeding - unclarified blood-formation disturbances - Ibuprofen should not be given to patients with conditions involving an increased tendency to bleeding.
Ibuprofen is contraindicated in children and adolescents younger than 15 years of age. 2). 4. 2, and GI and cardiovascular risks below). 5). Asthmatic patients are to seek their doctor's advice before using ibuprofen (see below). 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. acute intermittent porphyria) - The first and second trimester of pregnancy - Lactation Special care has to be taken in the following cases: - Gastrointestinal diseases including chronic inflammatory intestinal disease (ulcerative colitis, Crohn's disease) - Cardiac insufficiency and hypertension - Reduced renal function - Hepatic dysfunction - Disturbed haematopoiesis - Blood coagulation defects - Allergies, hay fever, chronic swelling of nasal mucosa, adenoids, chronic obstructive airway disease or bronchial asthma - Immediately after major surgical interventions 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.
g. 4). 6) - significant dehydration (caused by vomiting, diarrhoea or insufficient fluid intake) - cerebrovascular or other active bleeding - unclarified blood-formation disturbances - Ibuprofen should not be given to patients with conditions involving an increased tendency to bleeding.
Ibuprofen is contraindicated in children and adolescents younger than 15 years of age. 2). 4. CLINICAL PARTICULARS
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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4) Cardiac disorders Not known Kounis Syndrome Vascular disorders Very rare Hypertension Metabolism and Nutritional Disorders Not known Hypokalaemia* *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.
4. CLINICAL PARTICULARS
3), and in the elderly. These patients should commence treatment on the lowest dose available. g. misoprostol or proton pump inhibitors) should be considered for these patients, and also for patients requiring concomitant low-dose acetylsalicylic acid, or other medicinal products likely to increase gastrointestinal risk.
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 gastrointestinal disease (ulcerative colitis, Crohn's disease) as their condition may be exacerbated. 8). 2). Cardiovascular and cerebrovascular effects Appropriate monitoring and advice are required for patients with a history of hypertension and/or mild to moderate congestive 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 doses (2400 mg/day) 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 arterial thrombotic events.
Patients with uncontrolled hypertension, congestive heart failure (NYHA II III), established ischaemic heart disease, peripheral arterial disease, […]