Pajjiż: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
PRAVASTATIN SODIUM
Bristol-Myers Squibb Pharmaceuticals uc
C10AA03
PRAVASTATIN SODIUM
20 Milligram
Tablets
Product subject to prescription which may be renewed (B)
HMG CoA reductase inhibitors
Authorised
1997-10-31
PACKAGE LEAFLET: INFORMATION FOR THE USER LIPOSTAT 10MG, 20MG AND 40MG TABLETS Pravastatin sodium READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. 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 symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What LIPOSTAT is and what it is used for 2. Before you take LIPOSTAT 3. How to take LIPOSTAT 4. Possible side effects 5. How to store LIPOSTAT 6. Further information 1. WHAT LIPOSTAT IS AND WHAT IT IS USED FOR LIPOSTAT belongs to a group of medicines called statins (or HMG-CoA reductase inhibitors). It prevents the production of cholesterol by the liver and consequently reduces the levels of cholesterol and other fats (triglycerides) in your body. When there are excessive levels of cholesterol in the blood, the cholesterol accumulates on the walls of blood vessels and blocks them. This condition is called hardening of the arteries or atherosclerosis and it may lead to: chest pain (angina pectoris), when a blood vessel in the heart is partially blocked, a heart attack (myocardial infarction), when a blood vessel in the heart is completely blocked, a stroke (cerebrovascular accident), when a blood vessel in the brain is completely blocked. This medicine is used in 3 situations: In the treatment of high levels of cholesterol and fats in the blood LIPOSTAT is used to lower high levels of "bad" cholesterol and to raise the levels of "good" cholesterol in the blood when changes to diet and exercise have failed to adequately do this. In the prevention of heart and blood vessel diseases If you have high levels of cholesterol in your blood and risk factors favouring these diseases (if you smo Aqra d-dokument sħiħ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lipostat 20 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 20 mg pravastatin sodium. Each tablet contains 129.90 mg of lactose monohydrate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet Yellow, capsule shaped biconvex scored tablet with a "20" engraved on one side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS HYPERCHOLESTEROLAEMIA Treatment of primary hypercholesterolaemia or mixed dyslipidaemia, as an adjunct to diet, when response to diet and other non-pharmacological treatments (e.g. exercise, weight reduction) is inadequate. PRIMARY PREVENTION Reduction of cardiovascular mortality and morbidity in patients with moderate or severe hypercholesterolaemia and at high risk of a first cardiovascular event, as an adjunct to diet (see section 5.1). SECONDARY PREVENTION Reduction of cardiovascular mortality and morbidity in patients with a history of myocardial infarction (MI) or unstable angina pectoris and with either normal or increased cholesterol levels, as an adjunct to correction of other risk factors (see section 5.1). POST TRANSPLANTATION Reduction of post transplantation hyperlipidaemia in patients receiving immunosuppressive therapy following solid organ transplantation. (see sections 4.2, 4.5 and 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Prior to initiating Lipostat, secondary causes of hypercholesterolaemia should be excluded and patients should be placed on a standard lipid-lowering diet which should be continued during treatment. Lipostat is administered orally once daily preferably in the evening with or without food. HYPERCHOLESTEROLAEMIA: the recommended dose range is 10 - 40 mg once daily. The therapeutic response is seen within a week and the full effect of a given dose occurs within four weeks, therefore periodic lipid determinations should be performed and t Aqra d-dokument sħiħ