Kraj: Malezja
Język: angielski
Źródło: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
FLUVASTATIN
NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.
FLUVASTATIN
28Tablet Tablets
NOVARTIS FARMACEUTICA S.A.
_Consumer Medication Information Leaflet (RiMUP)_ LESCOL ® XL TABLET FLUVASTATIN SODIUM (80 MG) 1 WHAT IS IN THIS LEAFLET 1. WHAT LESCOL XL IS USED FOR 2. HOW LESCOL XL WORKS 3. BEFORE YOU USE LESCOL XL 4. HOW TO USE LESCOL XL 5. WHILE YOU ARE USING LESCOL XL 6. SIDE EFFECTS 7. STORAGE AND DISPOSAL OF LESCOL XL 8. PRODUCT DESCRIPTION 9. MANUFACTURER AND PRODUCT REGISTRATION HOLDER 10. DATE OF REVISION WHAT LESCOL XL IS USED FOR Cholesterol and triglycerides are the major lipid components that can be found in the blood. Cholesterol is mainly produced by the liver whereas most of the triglycerides in the blood are introduced with food. High levels of low-density lipoprotein cholesterol (LDL-C, the ‘bad’ cholesterol) have been associated with an increased risk of heart disease and stroke. In some cases, elevated levels of ‘bad’ cholesterol in blood are accompanied by moderate increases in triglycerides and low levels of high-density lipoprotein cholesterol (HDL-C, the ‘good’ cholesterol). However, it is important that both the ‘bad’ cholesterol and triglycerides in blood are reduced when elevated. Also it may be important that the levels of the ‘good’ cholesterol in blood are raised. Your doctor would have already suggested changes to your diet or life style in order to lower your ’bad’ cholesterol and triglycerides, if elevated, and to raise the ‘good’ cholesterol. Sometimes diet and life style changes alone will not be completely successful in achieving these targets. Your doctor will therefore prescribe additional treatment such as Lescol XL. HOW LESCOL XL WORKS _ADULTS _ Lescol XL also slows the progression of coronary atherosclerosis which causes a thickening and hardening of blood vessel walls at the heart and eventually obstruction. Your doctor can also prescribe Lescol XL for the prevention of further serious cardiac events (e.g. heart attack) in patients who still suffer from heart disease after they already went through a heart catheterisation. BEFORE YOU USE LESCOL XL Before t Przeczytaj cały dokument
Drug Regulatory Affairs LESCOL (FLUVASTATIN SODIUM) Gelatine capsules 20 mg and 40 mg LESCOL XL (FLUVASTATIN SODIUM) Prolonged release 80 mg tablets MALAYSIAN PACKAGE LEAFLET – OCT 2014 (WITHOUT PEDIATRIC INDICATION) FOR PROMOTIONAL MATERIALS PLEASE QUOTE THE FOLLOWING: PI RD 10 MAY 12; APPR 25 JUL 13 IPL Creator: CDS Author: Pedda Reddy Stéphanie Cébe GLC approval: 26 May 2011, amended 30 August2011and 24 April 2012 Release date: 10 May 2012 Tracking no.: 2012-PSB/GLC-0544-s Document status: Final Number of pages: 17 Novartis Page 2 Proposed Malaysian Package Leaflet 10 May 2012 Lescol®/Lescol® XL(without ped) LESCOL / LESCOL XL HMG-CoA reductase inhibitors DESCRIPTION AND COMPOSITION PHARMACEUTICAL FORM(S) Capsules and prolonged release tablets for oral administration. ACTIVE SUBSTANCE(S) [R*,S*-(E)]-( )-7-[3-(4-fluorophenyl)-1-(1-methylethyl)-1H-indol-2-yl]-3,5-dihydroxy-6- heptenoate (fluvastatin sodium) One capsule of Lescol contains 21.06 mg or 42.12 mg fluvastatin sodium equivalent to 20 mg or 40 mg fluvastatin free acid. One prolonged release tablet of Lescol XL contains 84.24 mg fluvastatin sodium equivalent to 80 mg fluvastatin free acid. Certain dosage strengths and dosage forms may not be available in all countries. DESCRIPTION LESCOL 20MG CAPSULE Hard gelatin capsule, cap is strong reddish brown opaque in colour and the body is pale yellow opaque with ‘XU 20 mg’ imprint in red. LESCOL 40MG CAPSULE Hard gelatin capsule, cap is strong reddish brown opaque in colour and the body is orange-yellow opaque with ‘XU 40 mg’ imprint in red. LESCOL XL 80MG FILM-COATED TABLET Yellow, round, slightly biconvex film-coated tablet with bevelled edges, approx. 10mm in diameter, debossed with “LE” on one side/ “NVR” on the other EXCIPIENTS LESCOL 20MG CAPSULE AND 40MG CAPSULES Magnesium stearate; sodium hydrogen carbonate; talc; cellulose microcrystalline, pregelatinised starch, calcium carbonate; titanium dioxide; iron oxide red, iron oxide yellow, gelatine; shellac. LESCO Przeczytaj cały dokument