Šalis: Airija
kalba: anglų
Šaltinis: HPRA (Health Products Regulatory Authority)
FLURBIPROFEN
Abbott Laboratories Ireland Ltd
FLURBIPROFEN
25 Milligram
Tablets
Product subject to prescription which may be renewed (B)
Withdrawn
2006-11-09
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Froben Tablets 25 mg. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 25 mg flurbiprofen. For excipients, see 6.1 3 PHARMACEUTICAL FORM Coated tablets. Yellow, circular, sugar-coated tablets, imprinted in black with an identifying motif (F25). 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Froben is indicated for the management of various arthroses such as rheumatoid arthritis and osteoarthritis, fibrositis, ankylosing spondylitis and other muscular syndromes such as low back pain. Froben is also used for the relief of acute and chronic pain. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration. _Adults: _The usual total daily dosage is 150 to 200 mg in divided doses. During the acute phase, the daily dose may be increased to 300 mg. _Elderly: _NSAIDs should be used with particular caution in elderly patients. Dosage should be at the lowest level of the range. Prolonged use should be avoided. Those patients with impaired renal function may eliminate NSAIDs more slowly than normal. In these cases, Froben should be used with caution and dosage should be assessed individually. Treatment should be reviewed at regular intervals and discontinued if no benefit is seen or intolerance occurs. 4.3 CONTRAINDICATIONS Froben is contra-indicated in children and during lactation. It is also contra-indicated in patients with active peptic ulceration, gastrointestinal haemorrhage or ulcerative colitis. Froben should not be used in patients with a history of asthma or in patients who have experienced bronchospasm, anaphylactic reactions, angioedema or other hypersensitivity-type reactions from the use of aspirin or other NSAIDs. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Undesirable effect Perskaitykite visą dokumentą