Страна: Великобритания
Език: английски
Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)
Fluvastatin sodium
Novartis Pharmaceuticals UK Ltd
C10AA04
Fluvastatin sodium
20mg
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02120000; GTIN: 5013054120148
PACKAGE LEAFLET: INFORMATION FOR THE USER LESCOL ® 20 MG CAPSULES, HARD Fluvastatin READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE, BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. -Keep this leaflet. You may need to read it again. -If you have any further questions, ask your doctor or pharmacist. -This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. -If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Lescol is and what it is used for 2. What you need to know before you take Lescol 3. How to take Lescol 4. Possible side effects 5. How to store Lescol 6. Contents of the pack and other information 1. WHAT LESCOL IS AND WHAT IT IS USED FOR Lescol contains the active substance fluvastatin sodium which belongs to a group of medicines known as statins, which are lipid-lowering medicines: they lower the fat (lipids) in your blood. They are used in patients whose conditions cannot be controlled by diet and exercise alone. Lescol is a medicine used to TREAT RAISED LEVELS OF FATS IN THE BLOOD IN ADULTS, in particular total cholesterol and so called “bad” or LDL cholesterol, which is associated with an increased risk of heart disease and stroke. in adult patients with high blood levels of cholesterol in adult patients with high blood levels of both cholesterol and triglycerides (another sort of blood lipid). Your doctor can also prescribe Lescol to prevent further serious cardiac events (e.g. heart attack) in patients who have already had a heart catheterisation, with an intervention in the heart vessel. If you have any questions about how Lescol works or why this medicine has been prescribed for you, ask your doctor. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LESCOL Follow all your doctor’s instructions carefully, even if they differ from the general information containe Прочетете целия документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lescol ® 20 mg capsules, hard 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: fluvastatin (as fluvastatin sodium) Each capsule contains 21.06 mg of fluvastatin sodium equivalent to 20 mg fluvastatin free acid. For the full list of excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Capsules, hard Cap: Strong reddish brown opaque. Body: Pale yellow opaque; imprint: XU 20 mg (red ink). 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 Posology _ _ _Adults _ Dyslipidaemia Prior to initiating treatment with Lescol, 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 fluvastatin may be used in the evening. For patients requiring LDL-C reduction to a goal of ≥ 25%, the recommended starting dose is 40 mg fluvastatin in the evening. The dose may be uptitrated to 80 mg fluvastatin daily, administered as a single dose (80 mg prolonged-release tablet) at any time of the day or as 40 mg of fluvastatin given twice daily (one dose in the morning and one dose in the evening). The maximum lipid-lowering effect with a given dose is achieved within 4 weeks. Dose adjustments should be made at intervals of 4 weeks or more. Secondary prevention in coronary heart disea Прочетете целия документ