Země: Irsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
FLUVASTATIN SODIUM
Rowex Ltd
80 Milligram
Tablet Prolonged Release
2008-05-30
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fluvat 80 mg prolonged-release tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One prolonged release tablet contains fluvastatin sodium equivalent to 80 mg fluvastatin. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged release tablet Yellow coloured, film-coated, round shaped, biconvex tablet with beveled edges. 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 fluvastatin, 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 20 mg capsule in the evening. For patients requiring LDL-C reduction to a goal of ≥25%, the recommended starting dose is 40 mg as one 40 mg capsule in the evening. The dose may be uptitrated to 80 mg daily, administered as a single dose (one prolonged-release tablet fluvastatin 80 mg) at any time of the day or as one 40 mg capsule given twice daily (one in the morning and one in the evening). T Přečtěte si celý dokument