Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
fenofibrate, Pravastatin
Laboratoires SMB S.A.
C10BA03
fenofibrate, pravastatin
Lipid modifying agents
Dyslipidemias
Pravafenix is indicated for the treatment of high-coronary-heart-disease (CHD)-risk adult patients with mixed dyslipidaemia characterised by high triglycerides and low HDL-cholesterol (C) levels whose LDL-C levels are adequately controlled while on a treatment with pravastatin-40-mg monotherapy.
Revision: 8
Authorised
2011-04-14
31 B. PACKAGE LEAFLET 32 PACKAGE LEAFLET: INFORMATION FOR THE USER PRAVAFENIX 40 MG/160 MG HARD CAPSULES pravastatin sodium/fenofibrate 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 Pravafenix is and what it is used for 2. What you need to know before you take Pravafenix 3. How to take Pravafenix 4. Possible side effects 5. How to store Pravafenix 6. Contents of the pack and other information 1. WHAT PRAVAFENIX IS AND WHAT IT IS USED FOR Pravafenix contains two active substances: pravastatin and fenofibrate. Both are cholesterol/lipid modifying medicines. PRAVAFENIX IS USED IN ADDITION TO LOW FAT DIET IN ADULTS - To lower the level of your ‘bad’ cholesterol (LDL cholesterol). It does this by lowering the level of total cholesterol, and fatty substances called triglycerides in the blood. - To raise the level of your ‘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. This clogging can slow or block blood flow to vital organs such as the heart and brain. When the blood flow is blocked, the result can be a heart attack or stroke. HDL cholesterol is often called ‘good’ cholesterol because it helps keep the ‘bad’ cholesterol Przeczytaj cały dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Pravafenix 40 mg/160 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 40 mg pravastatin sodium and 160 mg fenofibrate. Excipient(s) with known effect: Each hard capsule contains 19 mg of lactose monohydrate and 33.3 mg of sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule. Hard capsule, with light green body and olive cap, containing a waxy white beige mass and a tablet. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Pravafenix is indicated as an adjunct to diet and other non-pharmacological treatment (e.g. exercise, weight reduction) for the treatment of mixed hyperlipidaemia in adult patients at high cardiovascular risk to reduce triglycerides and increase HDL-C when LDL-C levels are adequately controlled while on a treatment with pravastatin 40 mg monotherapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Prior to initiating Pravafenix, secondary causes of combined dyslipidaemia should be excluded 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 capsule per day. Dietary restrictions instituted before therapy should be continued. Response to therapy should be monitored by determination of serum lipid values. Rapid reduction of serum lipid levels usually follows Pravafenix treatment, but treatment should be discontinued if an adequate response has not been achieved within three months. _Special populations _ _Elderly patients_ _(≥ 65 years old) _ Treatment initiation with Pravafenix should be decided after renal function has been evaluated (see section 4.4 Renal and urinary disorders). Limited safety data on Pravafenix is available in patients >75 years of age and care should be exercised. _ _ _Renal impairment _ Pravafenix is contraindicated in patients with moderate to severe renal impairment (defined as a creatinine clearance < 6 Przeczytaj cały dokument