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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 POM product (Ebufac): 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…
Verbatim from this product's MHRA label. Tap a section to expand.
For the POM product:
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms. 4).
Posology Adults:
The recommended dosage of ibuprofen is 1200 to 1800 mg daily in divided doses. Some patients can be maintained on 600 to 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 dosage does not exceed 2400 mg even in divided doses.
Paediatric population Children over 12 years of age:
The daily dosage of ibuprofen is 20 mg/kg of body weight in divided doses. For juvenile rheumatoid arthritis, up to 40 mg/kg of body weight daily in divided doses may be taken.
Children under 12 years of age:
Not recommended 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
). 8). Patients appear to be at highest risk of these reactions early in the course of therapy, the onset of the reaction occurring in the majority of cases within the first month of treatment. Acute generalised exanthematous pustulosis (AGEP) has been reported in relation to ibuprofen-containing products.
Ibuprofen should be discontinued, at the first appearance of signs and symptoms of severe skin reactions, such as skin rash, mucosal lesions, or any other sign of hypersensitivity. In exceptional cases, varicella can be at the origin of serious cutaneous and soft tissues infectious complications.
To date, the contributing role of NSAIDs in the worsening of these infections cannot be ruled out. Thus, it is advisable to avoid use of Ibuprofen in case of varicella. Masking of symptoms of underlying infections: ‘Migrafen 400 / Ebufac’ 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 ‘Migrafen 400 / Ebufac’ 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. Haematological effects Ibuprofen, like other NSAIDs, can interfere with platelet aggregation and prolong bleeding time in normal subjects. Aseptic meningitis Aseptic meningitis has been observed on rare occasions in patients on ibuprofen therapy.
Although it is probably more likely to occur in patients with systemic lupus erythematosus and related connective tissue diseases, it has been reported in patients who do not have an underlying chronic disease. PL 33414/0050 Page 7 of 15 Impaired female fertility The use of Ibuprofen may impair female fertility and is not recommended in women attempting to conceive.
3-Contraindications).
For the P product:
PL 33414/0050 Page 3 of 15 Adults and children over 12 years: 1 tablet to be taken with water. Subsequently, 1 tablet every four to six hours. If in adolescents (between 12 and 18 years) this medicinal product is required for more than 3 days, or if symptoms worsen a doctor should be consulted.
Maximum daily dose: three tablets in 24 hours. To be taken preferably after food.
Children under 12 years of age:
Not to be given to children under 12 years of age. 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. Ibuprofen tablets should be swallowed whole and not chewed, broken, crushed or sucked on to avoid oral discomfort and throat irritation. 1. g. asthma, urticaria, angioedema or rhinitis) after taking ibuprofen, aspirin and other NSAIDs.
Ibuprofen is also contraindicated in patients with a history of gastrointestinal bleeding or perforation, related to previous NSAID 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 for use by children under the age of 12 without medical advice if sold as a P product. 2, and GI and cardiovascular risks below).
As with other NSAIDs, ibuprofen may mask the signs of infection. 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.
1. g. asthma, urticaria, angioedema or rhinitis) after taking ibuprofen, aspirin and other NSAIDs. Ibuprofen is also contraindicated in patients with a history of gastrointestinal bleeding or perforation, related to previous NSAID 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 for use by children under the age of 12 without medical advice if sold as a P product.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of Ibuprofen should be considered. Excipients Iboprufen tablets contain sucrose and should not be given to patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
5 Interaction with other medicinal products and other forms of interaction Concurrent aspirin or other NSAIDs may result in an increased incidence of adverse reactions.
Acetylsalicylic acid:
Concomitant administration of ibuprofen and acetylsalicylic acid is not generally recommended because of the potential of increased adverse effects. Experimental data suggest that ibuprofen may competitively inhibit the effect of low dose acetylsalicylic acid on platelet aggregation when they are dosed concomitantly.
Although there are uncertainties regarding extrapolation of these data to the clinical situation, the possibility that regular, long-term use of ibuprofen may reduce the cardioprotective effect of low-dose acetylsalicylic acid cannot be excluded.
1).
Anti-coagulants:
May enhance the effects of anti-coagulants.
Anti-hypertensives:
NSAIDs may diminish the effect of anti-hypertensives.
Diuretics:
Reduced diuretic effect. Diuretics can increase the risk of nephrotoxicity of NSAIDs.
Cardiac glycosides:
NSAIDs may exacerbate renal failure, reduce GFR and increase plasma glycoside levels.
Cyclosporin:
Increased risk of nephrotoxicity.
Mifepristone:
NSAIDs should not be used for 8-12 days after mifepristone administration as they can reduce the effect of mifepristone.
Corticosteroids:
Increased risk of GI bleeding.
Quinolone antibiotics:
Animal data indicate that NSAIDs can increase the risk of convulsions associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may have an increased risk of developing convulsions.
Frusemide:
Ibuprofen reduces the natriuretic effect of frusemide and thiazide diuretics. This is thought to be due to the inhibition of renal prostaglandin synthesis. Patients being treated concomitantly with ibuprofen and thiazides or frusemide should be closely monitored.
Lithium:
Patients receiving ibuprofen and lithium should be observed for signs of lithium toxicity because ibuprofen has been shown to produce an elevation of plasma lithium levels and a reduction in renal lithium clearance.
PL 33414/0050 Page 8 of 15 Methotrexate:
When methotrexate is used concomitantly with ibuprofen, enhanced toxicity of methotrexate may ensue due to a reduction of renal tubular secretion of methotrexate. Exercise caution in these circumstances. 6 Pregnancy and lactation Whilst no teratogenic effects have been demonstrated in animal studies, ibuprofen should be avoided during pregnancy.
Congenital abnormalities have been reported in association with ibuprofen administration in man associated; however, these are low in frequency and do not appear to follow any discernible pattern. In view of the known effects of NSAIDS on the foetal cardiovascular system, closure of ductus arteriosus, use in late pregnancy should be avoided.
The onset of labour may be delayed and the duration of labour increased. Ibuprofen appears in breast milk at very low concentrations and is unlikely to affect the breast fed infant adversely. 7 Effects on ability to drive and use machines Migrafen 400/Ebufac' does not affect the ability to drive or use machines.
8 Undesirable effects Gastrointestinal disorders: The most commonly observed adverse events are gastrointestinal in nature. Peptic ulcers, perforation or GI bleeding, sometimes fatal, particularly in the elderly, may occur (see section […]
Patients with medication overuse headache should not be treated by increasing the dose of the analgesic. In such cases the use of analgesic 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.
2). Paediatric population There is a risk of renal impairment in dehydrated children and adolescents. Gastrointestinal bleeding, ulceration and perforation GI bleeding, ulceration or perforation, which can be fatal, have been reported for all NSAIDs at anytime 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.
g. 5). When GI bleeding or ulceration occurs in patients receiving Ibuprofen, the treatment should be withdrawn. 8). 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.
Cardiovascular, 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 […]