Nchi: Malta
Lugha: Kiingereza
Chanzo: Medicines Authority
FLUVASTATIN
Novartis Ireland Limited Vista Building, Elm Park, Merrion Road, Ballsbridge, Dublin 4,, Ireland
C10AA04
FLUVASTATIN 40 mg
HARD CAPSULE
FLUVASTATIN 40 mg
POM
LIPID MODIFYING AGENTS
Withdrawn
2005-08-03
PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE USER LESCOL 40 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 Lescolto 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 Lescolworks 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 Soma hati kamili
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Lescol 40 mg capsules, hard 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: fluvastatin (as fluvastatin sodium) Each capsule contains 42.12 mg of fluvastatin sodium equivalent to 40 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: Orange yellow opaque; imprint: XU 40 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 percutane- ous 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 reduc- tion 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 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 disease Soma hati kamili