Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
FLUVASTATIN SODIUM
Rowex Ltd
40 Milligram
Capsules Hard
2008-01-25
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fluvat 40 mg capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 42.12 mg fluvastatin sodium corresponding to 40 mg fluvastatin. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard Brown coloured capsule containing off-white to pale-yellow powder. 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). The maximum lipid-lowering effect with a give Read the complete document