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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 rheumatic 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.
Children:
The daily dosage of Ibuprofen is 20 mg/kg of body weight in divided doses. For young children, more suitable formulations are available. In Juvenile Rheumatoid Arthritis, up to 40 mg/kg of body weight daily in divided doses may be taken.
Not recommended for children weighing less than 7 kg.
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
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).
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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 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. g. 4) Kounis syndrome Vascular disorders Very rare Hypertension Metabolism and Nutritional Disorders Not known Hypokalaemia* 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.
3-Contraindications). Method of administration 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.
1. g. asthma, rhinitis, angioedema or urticaria) in response to ibuprofen, aspirin or other non- steroidal anti-inflammatory drugs. • Active or history of recurrent peptic ulcer/gastrointestinal haemorrhage (two or more distinct episodes of proven ulceration or bleeding).
• History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy. • conditions involving an increased tendency to bleeding. 6). 4 Special warnings and precautions for use 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).
5). The diagnosis of medication overuse headache (MOH) should be suspected in patients who have frequent or daily headaches despite (or because of) the regular use of analgesic medication. Patients with medication overuse headache should not be treated by increasing the dose of the analgesic.
In such cases the use of analgesics should be discontinued. The concomitant consumption of excessive alcohol with NSAIDs, including ibuprofen may increase the risk of adverse effects on the gastrointestinal tract, such as GI haemorrhage or the central nervous system, possibly due to an additive effect.
The elderly have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
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 diseases since NSAIDs have been reported to precipitate bronchospasm, urticaria or angioedema in such patients.
1. g. asthma, rhinitis, angioedema or urticaria) in response to ibuprofen, aspirin or other non- steroidal anti-inflammatory drugs. • Active or history of recurrent peptic ulcer/gastrointestinal haemorrhage (two or more distinct episodes of proven ulceration or bleeding).
• History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy. • conditions involving an increased tendency to bleeding. 6).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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). 5). 8).
Renal effects:
Caution should be used when initiating treatment with ibuprofen in patients with considerable dehydration. There is a risk of renal impairment especially in dehydrated children, adolescents and the elderly. 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-dependant 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.
8). Clinical trial and epidemiological data suggest that use of ibuprofen, particularly at high doses (2400 mg 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. ≤ 1200 mg daily) is associated with an increased risk of myocardial infarction. Cases of Kounis syndrome have been reported in patients treated with Ibuprofen 600mg film-coated tablets Kounis syndrome has been defined as cardiovascular symptoms secondary to an allergic or hypersensitive reaction associated with constriction of coronary arteries and […]