País: Irlanda
Idioma: inglés
Fuente: HPRA (Health Products Regulatory Authority)
TIAPROFENIC ACID
Sanofi-Aventis Ireland Limited
300 Milligram
Tablets
2002-04-29
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Surgam 300 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 300 mg of tiaprofenic acid. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Tablets White to cream-white, round, biconvex tablets with a breakline imprinted ‘Surgam’ and ‘300’ on either side of the breakline and with the Roussel logo on the reverse side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As an anti-inflammatory agent in the symptomatic management of rheumatoid arthritis; osteoarthritis; ankylosing spondolytis; low back pain; musculo-skeletal disorders such as fibrositis, capsulitis, epicondylitis and other sort tissue inflammatory conditions; sprains and strains, post-operative inflammation and pain, and other soft-tissue injuries. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Route of administration: Oral. Adults: The usual total daily does is 600 mg divided in doses. Children: There are insufficient data to recommend the use of Surgam in children. Elderly: As for adults (see Section 4.4 Warning and Precaution). NSAIDs should be used with particular caution in older patients who generally are more prone to adverse reactions. Continuous use over prolonged periods is not recommended. In cases of renal, cardiac or hepatic impairment, the does should be kept as low as possible. It is suggested that in such cases the dosage be reduced to 200mg twice daily. Treatment should be reviewed at regular intervals and discontinued if no benefit is seen or if intolerance occurs. 4.3 CONTRAINDICATIONS Active gastroduodenal ulceration, history of gastroduodenal ulceration. Active bladder or prostatic disease or symptoms. History of recurrent urinary tract disorders. Hypersensitivity (e.g. bronchospasm, rhinitis, urticaria) to Leer el documento completo