Land: Storbritannien
Sprog: engelsk
Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Flurbiprofen
Abbott Laboratories Ltd
M01AE09
Flurbiprofen
100mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 10010100; GTIN: 5016565111223
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Froben Tablets 100 mg Flurbiprofen 100 mg coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Froben Tablets 100 mg contain 100 mg flurbiprofen EP. Flurbiprofen 100 mg coated tablets contain 100 mg flurbiprofen EP. 3 PHARMACEUTICAL FORM The tablets are 10.0 mm in diameter, sugar-coated and white in colour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of rheumatoid disease, osteoarthritis, ankylosing spondylitis, musculoskeletal disorders and trauma such as periarthritis, frozen shoulder, bursitis, tendinitis, tenosynovitis, low back pain, sprains and strains. Flurbiprofen is also indicated for its analgesic effect in the relief of mild to moderate pain in conditions such as dental pain, post-operative pain, dysmenorrhoea and migraine. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration. To be taken preferably with or after food. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see Section 4.4). _Adults_: 150 to 200 mg daily in two, three or four divided doses. In patients with severe symptoms or disease of recent origin, or during acute exacerbations, the total daily dosage may be increased to 300 mg in divided doses. For dysmenorrhoea, a dosage of 100 mg may be administered at the start of symptoms followed by 50 or 100 mg given at four- to six-hour intervals. The maximum total daily dosage should not exceed 300 mg. _Paediatric population_: Not recommended for use in children under 12 years. _Older people _: The elderly are at increased risk of the serious consequences of adverse reactions. Although flurbiprofen is generally well tolerated in the elderly, some patients, especially those with impaired renal function, may eliminate NSAIDs more slowly than normal. In these cases, flurbiprofen should be used with caution and dosage should be assessed individually. If an NSAID is considered necessary, the lowest effective dose sh Læs hele dokumentet