Country: Եվրոպական Միություն
language: անգլերեն
source: EMA (European Medicines Agency)
laropiprant, nicotinic acid
Merck Sharp Dohme Ltd.
C10AD52
laropiprant, nicotinic acid
Lipid modifying agents
Dyslipidemias
Tredaptive is indicated for the treatment of dyslipidaemia, particularly in patients with combined mixed dyslipidaemia (characterised by elevated levels of low-density-lipoprotein (LDL) cholesterol and triglycerides and low high-density-lipoprotein (HDL) cholesterol) and in patients with primary hypercholesterolaemia (heterozygous familial and non-familial).Tredaptive should be used in patients in combination with 3-hydroxy-3-methyl-glutaryl-co-enzyme-A (HMG-CoA)-reductase inhibitors (statins), when the cholesterol-lowering effect of HMG-CoA-reductase inhibitor monotherapy is inadequate. It can be used as monotherapy only in patients in whom HMG-CoA-reductase inhibitors are considered inappropriate or not tolerated. Diet and other non-pharmacological treatments (e.g. exercise, weight reduction) should be continued during therapy with Tredaptive.
Revision: 11
Withdrawn
2008-07-03
29 B. PACKAGE LEAFLET Medicinal product no longer authorised 30 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT TREDAPTIVE 1,000 MG/20 MG MODIFIED-RELEASE TABLETS nicotinic acid/laropiprant 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. WHAT IS IN THIS LEAFLET: 1. What Tredaptive is and what it is used for 2. What you need to know before you take Tredaptive 3. How to take Tredaptive 4. Possible side effects 5. How to store Tredaptive 6. Contents of the pack and other information 1. WHAT TREDAPTIVE IS AND WHAT IT IS USED FOR The name of your medicine is Tredaptive. It contains two different active substances: • nicotinic acid, a lipid modifying medicine, and • laropiprant, which reduces symptoms of flushing, a common side effect of nicotinic acid. HOW TREDAPTIVE WORKS TREDAPTIVE IS USED IN ADDITION TO DIET • to lower your ‘bad’ cholesterol level. It does this by lowering the levels of total cholesterol, LDL cholesterol, fatty substances called triglycerides and apo B (a part of LDL) in the blood; • to raise levels of ‘good’ cholesterol (HDL cholesterol) and apo A-I (a part of HDL). WHAT SHOULD I KNOW ABOUT CHOLESTEROL AND TRIGLYCERIDES? Cholesterol is one of several fats found in your blood. Your total cholesterol is made up mainly of ‘bad’ (LDL) and ‘good’ (HDL) cholesterol. LDL cholesterol is often called ‘bad’ cholesterol because it can build up in the walls of your arteries and form plaque. Over time, this plaque build-up can lead to a clogging of your arteries. This clogging can slow or block blood flow to vital read_full_document
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Tredaptive 1,000 mg/20 mg modified-release tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each modified-release tablet contains 1,000 mg of nicotinic acid and 20 mg of laropiprant. Excipient(s) with known effect: Each modified-release tablet contains 128.4 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Modified-release tablet. Capsule-shaped, white to off-white tablet, with “552” debossed on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Tredaptive is indicated for the treatment of dyslipidaemia, particularly in adult patients with combined mixed dyslipidaemia (characterised by elevated levels of LDL-cholesterol and triglycerides and low HDL-cholesterol) and in adult patients with primary hypercholesterolaemia (heterozygous familial and non-familial). Tredaptive should be used in patients in combination with HMG-CoA reductase inhibitors (statins), when the cholesterol lowering effect of HMG-CoA reductase inhibitor monotherapy is inadequate. It can be used as monotherapy only in patients in whom HMG-CoA reductase inhibitors are considered inappropriate or not tolerated. Diet and other non-pharmacological treatments (e.g. exercise, weight reduction) should be continued during therapy with Tredaptive. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The starting dose is one modified-release tablet (1,000 mg nicotinic acid/20 mg laropiprant) once a day. After four weeks, it is recommended that patients be advanced to the maintenance dose of 2,000 mg/40 mg taken as two modified-release tablets (1,000 mg/20 mg each) once daily. Daily doses greater than 2000 mg/40 mg have not been studied and therefore are not recommended. If Tredaptive is missed for less than 7 consecutive days, patients can resume therapy at the last administered dose. If Tredaptive is missed for 7 or more consecutive days, therapy should be resumed at the read_full_document