Страна: Ирландия
Език: английски
Източник: HPRA (Health Products Regulatory Authority)
FLUVASTATIN SODIUM
PCO Manufacturing
80 Milligram
Tablet Prolonged Release
2006-11-10
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lescol XL 80 mg Prolonged-release Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged release tablet contains 80 mg of Fluvastatin as Fluvastatin Sodium For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged release tablet. _Product imported from Italy and Greece:_ Yellow, round tablets, debossed with “NVR” on one side and “LE” on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS LESCOL/LESCOL XL is indicated as an adjunct to diet for the reduction of elevated total cholesterol (total-C) and low-density lipoprotein cholesterol (LDL-C), in patients with primary hypercholesterolaemia and mixed dyslipidaemia (Fredrickson Types IIa and IIb). LESCOL/Lescol XL is also indicated for the secondary prevention of major adverse cardiac events (coronary revascularisation, cardiac death and non-fatal myocardial infarction) in patients with coronary heart disease after coronary transcatheter therapy (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Dosage for adults Prior to initiating treatment with Lescol/Lescol XL, the patient should be placed on a standard cholesterol-lowering diet. Dietary therapy should be continued during treatment. The recommended starting dose is 40 mg (1 capsule Lescol 40 mg once daily) or 80 mg (1 tablet Lescol XL 80 mg or 1 Lescol 40 mg capsules twice daily). The dose of 20 mg fluvastatin (1 capsule Lescol 20 mg) may be adequate in mild cases. Starting doses should be individualized according to baseline LDL-C levels and the recommended goal of therapy to be accomplished. In patients with coronary heart disease after coronary transcatheter therapy the appropriate dose is 80 mg daily. Lescol may be taken in the evening or at bedt Прочетете целия документ