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IBUPROFEN FILM COATED 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 effect in rheumatoid arthritis (including juvenile rheumatoid arthritis or Still’s disease) ankylosing spondylitis, osteoarthritis and other non-rheumatoid arthropathies. In non-articular rheumatoid conditions, ibuprofen is indicated in periarticular…
Verbatim from this product's MHRA label. Tap a section to expand.
4). The patient should consult a doctor if symptoms persist or worsen, or if the product is required for more than 10 days.
Adults:
Initial dosage is 1800 mg daily in divided doses. Some patients can be maintained on 600 -1800 mg daily. In severe or acute conditions it may be advantageous to increase the dosage provided that the total daily dosage does not exceed 2400 mg in divided doses.
Elderly:
The elderly are at increased risk of the 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.
Children:
Ibuprofen 600 mg tablets are not suitable for children. 4). For infants aged 3 - 5 months medical advice should be sought if symptoms worsen or not later than 24 hours if symptoms persist. If in children and in adolescents this medical product is required for more than 3 days, or if symptoms worsen a doctor should be consulted.
Method of administration:
For oral administration. To be taken preferably with or after food.
Gastrointestinal disorders:
The most commonly observed adverse events are gastrointestinal in nature. 4). 4) have been reported following ibuprofen administration. Less frequently, gastritis, duodenal ulcer, gastric ulcer and gastrointestinal perforation have been observed.
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).
Cardiac disorders and vascular disorders:
Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment. 4). 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: 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).
2, and GI and cardiovascular risks below). As with other NSAIDs, ibuprofen may mask the signs of infection. 5). 2). Paediatric population There is a risk of renal impairment in dehydrated children and adolescents.
Respiratory disorders and hypersensitivity reactions:
Caution is required if Ibuprofen is administered to patients suffering from or with a previous history of bronchial asthma, chronic rhinitis or allergic disorders, since NSAIDs have been reported to precipitate bronchospasm, urticarial or angioedema in such patients.
The possibility of cross-sensitivity with aspirin and other NSAIDs should be borne in mind. 8).
Renal effects:
Caution should be used when initiating treatment with ibuprofen in patients with considerable dehydration. As with other NSAIDs, long-term administration of ibuprofen has resulted in renal papillary necrosis and other renal pathologic changes.
Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. In these patients, administration of an NSAID may cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which may cause renal failure.
Patients at greatest risk of this reaction are those with impaired renal function, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors and the elderly. Discontinuation of NSAID therapy is usually 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.
1. g. asthma, rhinitis, angioedema or urticaria) after taking ibuprofen, aspirin or other NSAIDs. • Ibuprofen is also contraindicated in patients with a history of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy.
Ibuprofen should not be used in patients with active or history of recurrent peptic ulcer or gastrointestinal haemorrhage (two or more distinct episodes of proven ulceration or bleeding). • Ibuprofen should not be given to patients with conditions involving an increased tendency to bleeding.
4). 6).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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System Organ Class Frequency Adverse Events Common Dyspepsia, diarrhoea, nausea, vomiting, abdominal pain, flatulence, constipation, melaena, haematemesis, gastrointestinal haemorrhage Uncommon: Gastritis, duodenal ulcer, gastric ulcer, mouth ulceration, gastrointestinal perforation Very rare: Pancreatitis Gastrointestinal Disorders Not Known Exacerbation of ulcerative colitis and Crohn’s disease.
4) Blood and lymphatic system disorders Rare Leukopenia, thrombocytopenia, neutropenia, agranulocytosis, aplastic anaemia, haemolytic anaemia Uncommon Insomnia, anxietyPsychiatric disorders Rare Depression, confusional state Common Headache, dizziness Uncommon: Paraesthesia, somnolence, drowsiness Nervous System Disorders Rare Optic neuritis.
g. renal failure, tubulointerstitial nephritis, nephrotic syndrome, papillary necrosis, especially in long term use, associated with increased serum urea and oedema. Haematuria. Fluid retention may rarely precipitate congestive heart failure in elderly patients.
Very rare Acute renal failure Renal and Urinary Disorders Not Known Ureteric colic, dysuria, Renal tubular acidosis*, Renal insufficiency Common Fatigue General disorders administration site conditions Rare Oedema Uncommon Hepatitis, jaundice, hepatic function abnormal Hepatobiliary Disorders Very rare: Hepatic failure Common Rash Uncommon: Urticaria, pruritus, purpura, angioedema Very rare: Severe cutaneous adverse reactions (SCARs) (including, exfoliative dermatitis, Erythema multiforme, bullous reactions,including Stevens- Johnson syndrome, and toxic epidermal necrolysis) Skin and Subcutaneous Tissue Disorders Not known Fixed drug eruption Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), Acute generalised exanthematous pustulosis (AGEP), photosensitivity reaction Immune System Disorders Rare Anaphylactic reaction Investigations Very rare Decreased haemoglobin levels 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.
Cardiac, renal and hepatic impairment:
The administration of an NSAID may cause a dose dependent reduction in prostaglandin formation and precipitate renal failure. The habitual concomitant intake of various similar painkillers further increases this risk. Patients at greatest risk of this reaction are those with impaired renal function, cardiac impairment, liver dysfunction, those taking diuretics and the elderly.
3). Ibuprofen should be given with care to patients with as history of heart failure or hypertension since oedema has been reported in association with Ibuprofen administration There is a risk of renal impairment in dehydrated children and adolescents.
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.
Cases of Kounis syndrome have been reported in patients treated with Ibuprofen 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.
Clinical studies suggest that use of ibuprofen, particularly at high doses (2400 mg/day) and in long-term treatment may be associated with a small increased risk of arterial thrombotic events such as 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.
g. hypertension, hyperlipidaemia, diabetes mellitus, smoking), particularly if high doses of ibuprofen (2400 mg/day) are required.
Impaired female fertility:
The use of ibuprofen may impair female fertility and is not recommended in women attempting to conceive. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of ibuprofen should be considered.
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 gastrointestinal disease, particularly when elderly, should report any unusual […]