Šalis: Europos Sąjunga
kalba: anglų
Šaltinis: EMA (European Medicines Agency)
fenofibrate, simvastatin
Viatris Healthcare Limited
C10BA04
fenofibrate, simvastatin
Lipid modifying agents
Dyslipidemias
Cholib is indicated as adjunctive therapy to diet and exercise in high cardiovascular risk adult patients with mixed dyslipidaemia to reduce triglycerides and increase HDL C levels when LDL C levels are adequately controlled with the corresponding dose of simvastatin monotherapy.
Revision: 16
Authorised
2013-08-26
54 B. PACKAGE LEAFLET 55 PACKAGE LEAFLET: INFORMATION FOR THE USER CHOLIB 145 MG/20 MG FILM-COATED TABLETS fenofibrate/simvastatin 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. 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 Cholib is and what it is used for 2. What you need to know before you take Cholib 3. How to take Cholib 4. Possible side effects 5. How to store Cholib 6. Contents of the pack and other information 1. WHAT CHOLIB IS AND WHAT IT IS USED FOR Cholib contains two different active substances: fenofibrate (belongs to the group called ‘fibrates’) and simvastatin (belongs to the group called ‘statins’). They are both used to lower levels of total cholesterol, “bad” cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. In addition, they both raise levels of “good” cholesterol (HDL cholesterol). 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 LDL and 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. HDL cholesterol is often called ‘good’ cholesterol because it helps keep the ‘bad’ cholesterol from building up in the arteries and because it protects against heart disease. Triglycerides are another fat in your blood. They may raise your risk of having heart problems. In most people, there are no signs of cholesterol or Perskaitykite visą dokumentą
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Cholib 145 mg/20 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One film-coated tablet contains 145 mg of fenofibrate and 20 mg of simvastatin. Excipient(s) with known effect: One film-coated tablet contains 160.1 mg of lactose (as monohydrate), 145 mg of sucrose, 0.7 mg of lecithin (derived from soya bean (E322)) and 0.17 mg of sunset yellow FCF (E110). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Oval, biconvex, tan coloured, film-coated tablet, with bevelled edges and 145/20 on one side. The diameter dimensions are 19.3 x 9.3 mm approximately and the tablet weight is about 734 mg. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cholib is indicated as adjunctive therapy to diet and exercise in high cardiovascular risk adult patients with mixed dyslipidaemia to reduce triglycerides and increase HDL-C levels when LDL-C levels are adequately controlled with the corresponding dose of simvastatin monotherapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Secondary causes of hyperlipidaemia, such as uncontrolled type 2 diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemia, obstructive liver disease, pharmacological treatment (like oral oestrogens), alcoholism should be adequately treated, before Cholib therapy is considered and patients should be placed on a standard cholesterol and triglycerides-lowering diet which should be continued during treatment. Posology The recommended dose is one tablet per day. Grapefruit juice should be avoided (see section 4.5). Response to therapy should be monitored by determination of serum lipid values (total cholesterol (TC), LDL-C, triglycerides (TG)). _Elderly patients (≥ 65 years old) _ No dose adjustment is necessary. The usual dose is recommended, except for decreased renal function with estimated glomerular filtration rate < 60 mL/min/1.73 m 2 where Cholib is contraindicated (see section 4.3). _Patients w Perskaitykite visą dokumentą