País: Irlanda
Idioma: inglés
Fuente: HPRA (Health Products Regulatory Authority)
FLUVASTATIN SODIUM
B & S Healthcare
80 Base Milligrams
Tablet Prolonged Release
2009-12-11
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lescol XL 80mg Prolonged Release Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One prolonged-release tablet of Lescol XL contains 84.24 mg fluvastatin sodium equivalent to 80 mg fluvastatin free acid. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged Release Tablet _Product imported from _Greece: Yellow, circular, slightly biconvex film-coated tablet with bevelled edges engraved with “NVR” on one side and “LE” on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Dyslipidaemia Treatment of adults with primary hypercholesterolaemia or mixed dyslipidaemia, as an adjunct to diet, when response to diet and other non-pharmacological treatments (e.g. exercise, weight reduction) is inadequate. Secondary prevention in coronary heart disease Secondary prevention of major adverse cardiac events in adults with coronary heart disease after percutaneous coronary interventions (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Adults_ Dyslipidaemia Prior to initiating treatment with Lescol/Lescol XL, patients should be placed on a standard cholesterol lowering diet, which should be continued during treatment. Starting and maintenance doses should be individualized according to the baseline LDL-C levels and the treatment goal to be accomplished. The recommended dosing range is 20 to 80 mg/day. For patients requiring LDL-C reduction to a goal of < 25% a starting dose of 20 mg may be used as one capsule in the evening. For patients requiring LDL-C reduction to a goal of 25%, the recommended starting dose is 40 mg as one capsule in the evening. The dose may be uptitrated to 80 mg daily, administered as a single dose (one Lescol XL tablet) at any time of the d Leer el documento completo