Država: Evropska unija
Jezik: angleščina
Source: EMA (European Medicines Agency)
colesevelam (as hydrochloride)
CHEPLAPHARM Arzneimittel GmbH
C10AC04
colesevelam
Lipid modifying agents
Hypercholesterolemia
Cholestagel co-administered with a 3-hydroxy-3-methyl-glutaryl-coenzyme-A (HMG-CoA)-reductase inhibitor (statin) is indicated as adjunctive therapy to diet to provide an additive reduction in low-density-lipoprotein-cholesterol (LDL-C) levels in adult patients with primary hypercholesterolaemia who are not adequately controlled with a statin alone.Cholestagel as monotherapy is indicated as adjunctive therapy to diet for reduction of elevated total cholesterol and LDL-C in adult patients with primary hypercholesterolaemia, in whom a statin is considered inappropriate or is not well tolerated.Cholestagel can also be used in combination with ezetimibe, with or without a statin, in adult patients with primary hypercholesterolaemia, including patients with familial hypercholesterolaemia (see section 5.1).
Revision: 23
Authorised
2004-03-09
17 B. PACKAGE LEAFLET 18 PACKAGE LEAFLET: INFORMATION FOR THE USER CHOLESTAGEL 625 MG FILM-COATED TABLETS Colesevelam READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 Cholestagel is and what it is used for 2. What you need to know before you take Cholestagel 3. How to take Cholestagel 4. Possible side effects 5. How to store Cholestagel 6. Contents of the pack and other information 1. WHAT CHOLESTAGEL IS AND WHAT IT IS USED FOR Cholestagel contains the active substance colesevelam (as hydrochloride). Taking Cholestagel helps to lower the level of cholesterol in your blood. Your doctor should only give you Cholestagel if a diet low in fat and cholesterol did not work well enough on its own. Cholestagel works in your intestinal system by binding bile acids produced by your liver and carrying the bile acids out of your body with your faeces. This prevents your body from recycling the bile acids from your intestines in the usual way. Without the recycling process, your liver has to make additional bile acids. Your liver uses cholesterol from your blood to do this, which lowers the level of cholesterol in your blood. Cholestagel is prescribed to treat a condition known as primary hypercholesterolaemia (when cholesterol in the blood is elevated) in adults. - Cholestagel may be prescribed on its own in addition to a diet low in fat and cholesterol when treatment with a statin (a class of cholesterol-lowering medicines that work in the liver) is inappropriate or not well tolerated. - Cholestagel may be u Preberite celoten dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Cholestagel 625 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 625 mg colesevelam (as hydrochloride). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Off-white, capsule-shaped film-coated tablets imprinted with “C625” on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cholestagel co-administered with a 3-hydroxy-3-methyl-glutaryl-coenzyme A (HMG-CoA) reductase inhibitor (statin) is indicated as adjunctive therapy to diet to provide an additive reduction in low-density lipoprotein cholesterol (LDL-C) levels in adult patients with primary hypercholesterolaemia who are not adequately controlled with a statin alone. Cholestagel as monotherapy is indicated as adjunctive therapy to diet for reduction of elevated total-cholesterol and LDL-C in adult patients with primary hypercholesterolaemia, in whom a statin is considered inappropriate or is not well-tolerated. Cholestagel can also be used in combination with ezetimibe, with or without a statin, in adult patients with primary hypercholesterolaemia, including patients with familial hypercholesterolaemia (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Combination therapy _ The recommended dose of Cholestagel for combination with a statin with or without ezetimibe is 4 to 6 tablets per day. The maximum recommended dose is 6 tablets per day taken as 3 tablets twice per day with meals or 6 tablets taken once per day with a meal. Clinical trials have shown that Cholestagel and statins can be co-administered or dosed apart, and that Cholestagel and ezetimibe can be co- administered or dosed apart. _ _ _Monotherapy _ The recommended starting dose of Cholestagel is 6 tablets per day taken as 3 tablets twice per day with meals or 6 tablets once per day with a meal. The maximum recommended dose is 7 tablets per day. During therapy, the cholesterol-lowering diet shoul Preberite celoten dokument