Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
IBUPROFEN
Actavis Group PTC ehf
800 Milligram
Film Coated Tablet
2009-07-31
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Buplex Rx 800 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film -coated tablet contains 800 mg ibuprofen. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film -coated tablet. White, oval, biconvex film -coated tablets with a score on one face. The tablet can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Rheumatic conditions such as arthritic diseases (e.g. rheumatoid arthritis including juvenile rheumatoid arthritis), degenerative arthritic conditions (e.g. osteoarthritis), non-articular rheumatic conditions, other muscular and joint disorders, and soft tissue injuries. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). The ibuprofen dose depends on the patient’s age and body weight. The maximum single daily dose for adults should not exceed 800 mg of ibuprofen. The tablet should be swallowed with a glass of water during or after a meal. _RHEUMATIC DISEASES_ _Adults:_ The usual dose is 400 -600 mg 3 times a day. Maintenance doses of 600 mg-1200 mg daily may be effective in some patients. In acute and severe conditions the dose may be increased to a maximum of 2400 mg in 3 or 4 divided doses. _Adolescents over 12 years of age (>40 kg):_ The recommended dose is 20 mg/kg to a maximum of 40 mg/kg body weight daily in 3 to 4 divided doses. There are other dosage forms which may be more suitable to attain the required posology in this age and body weight group. _ELDERLY_ NSAIDs should be used with particular caution in elderly patients who are more prone to adverse events and are at in Read the complete document