Šalis: Airija
kalba: anglų
Šaltinis: HPRA (Health Products Regulatory Authority)
IBUPROFEN
Mercury Pharmaceuticals (Ireland) Ltd
IBUPROFEN
400 Milligram
Tablets
Withdrawn
2008-02-20
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Bufigen Tablets 400 mg. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 400 mg of Ibuprofen B.P For excipients, see 6.1. 3 PHARMACEUTICAL FORM Tablets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the management of various arthroses such as rheumatoid arthritis 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. Bufigen may be used for its analgesic effect in the relief of mild to moderate pain. 4.2 POSOLOGY AND METHOD OF ADMINSTRATION Bufigen tablets are for oral administration. _Adults_: The usual daily dose is 1200 to 1800 mg daily in divided doses. Some patients can be maintained on 600-1200 mg. The maximum recommended daily dose is 2400 mg. _Elderly_: No special dosage modifications are required for elderly patients, unless hepatic or renal function is impaired, in which case dosage should be assessed individually. _Children_: 20 mg per kg of body weight daily in divided doses for children over 30 kg body weight. The total dose in children weighing less than 30 kg should not exceed 500 mg in 24 hours. Not recommended for children weighing less than 7kg. 4.3 CONTRAINDICATIONS Bufigen should not be administered to patients with active peptic ulceration. Bufigen should not be used in patients with a known hypersensitivity to ibuprofen, nor should it be given to patients in whom ibuprofen, aspirin or other non- steroidal anti-inflammatory drugs induce the symptoms of bronchospasm, rhinitis or urticaria. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 27/02/2006_ _C Perskaitykite visą dokumentą