Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
IBUPROFEN
Abbott Laboratories Ireland Ltd
600 Milligram
Film Coated Tablet
2004-10-19
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Brufen 600mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 600 mg of ibuprofen. Excipients: each tablet contains 40.0mg of lactose monohydrate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet (tablet). A white, pillow-shaped, film-coated tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Brufen is indicated in the symptomatic management of various arthroses such as rheumatoid arthritis (including juvenile rheumatoid arthritis or Still’s disease) and osteoarthritis, fibrositis, ankylosing spondylitis and other muscular syndromes, such as low back pain, soft tissue trauma and various inflammations of tendon, joint capsules and ligaments. Brufen is also used as an analgesic in the relief of mild to moderate pain. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). Adults: The recommended dosage of Brufen is 1200-1800 mg daily in divided doses. Some patients can be maintained on 600-1200 mg daily. The total daily dose should not exceed 2400 mg. Children: The recommended dose of Brufen is 20 mg/kg bodyweight daily in divided doses but in juvenile rheumatoid arthritis, the daily dosage may be increased to 40 mg/kg bodyweight in severe cases. In children weighing less than 30 kg, the total daily dose of Brufen should not exceed 500 mg (the liquid formulation should be used). Elderly: No specific dosage modifications are required for elderly patients, unless renal or hepatic function is impaired, in which case, dosage should be assessed individually. NSAIDs should be used w Read the complete document