Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
NAPROXEN
McDermott Laboratories Ltd t/a Gerard Laboratories
250 Milligram
Tablets Gastro-Resistant
1998-02-20
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Gerinap E.C. 250mg Gastro-resistant Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 250 mg of Naproxen. Excipients: Each tablet contains 8 mg lactose monohydrate. For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Gastro-resistant tablets. White, circular, biconvex tablets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the management of various arthritides, such as rheumatoid arthritis, osteoarthrosis, spondylitis, gout, etc., and of musculoskeletal disorders. For the management of rheumatoid arthritis in children over the age of five years. In the management of dysmenorrhoea. 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, Special warnings and precautions for use_). Gerinap EC tablets should be swallowed whole and not broken or crushed. Adults The usual dose is 250mg daily, with a maximum daily dose of 1000mg. In the case of gout a dose of 750mg may be required as an initial dose given once, with 250mg every eight hours thereafter for a maximum of 72 hours. Subsequently use may be made of the usual regimen if necessary. For dysmenorrhoea the usual initial dose is 500mg and thereafter 250mg every 6 to 8 hours. Elderly NSAIDs should be used with particular caution in elderly patients who are more prone to adverse events. The lowest dose compatible with adequate safe clinical control should be employed. See also (_see section 4.4, Special warnings_ _and precautions for use_) Treatment should be reviewed at regular intervals and discontinued if no benefit is seen or intolerance occurs. IRISH MEDICINES BOARD _______ Read the complete document