LESCOL XL
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
17-05-2024
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Active ingredient:
FLUVASTATIN SODIUM
Available from:
PCO Manufacturing
Dosage:
80 Milligram
Pharmaceutical form:
Tablet Prolonged Release
Authorization date:
2006-11-10
Summary of Product characteristics
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
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