Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
PRAVASTATIN SODIUM
Apotex Europe Limited
PRAVASTATIN SODIUM
20 Milligram
Tablets
Product subject to prescription which may be renewed (B)
Authorised
0000-00-00
Package leaflet: Information for the patient PRAVAT 10 MG TABLETS PRAVAT 20 MG TABLETS PRAVAT 40 MG TABLETS Pravastatin sodium 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 Pravat is and what it is used for 2. What you need to know before you take Pravat 3. How to take Pravat 4. Possible side effects 5. How to store Pravat 6. Contents of the pack and other information 1. WHAT PRAVAT IS AND WHAT IT IS USED FOR Pravat contains pravastatin sodium as the active ingredient. Pravastatin belongs to a group of medicines called HMG-CoA reductase inhibitors also known as statins, which work by lowering your body’s production of cholesterol. If you already have heart disease, pravastatin reduces the risk of you having another heart attack or stroke, reduces the need for heart surgery and slows down any further narrowing of your arteries. If you do not have heart disease but have high cholesterol levels, pravastatin reduces the risk of you having a heart attack or needing heart surgery. Pravastatin should always be used together with a low fat diet. If you have had an organ transplant and are taking medication to stop your body rejecting the transplant, pravastatin reduces increased lipid leve Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Pravat 20 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains pravastatin sodium 20 mg Excipient with known effect: Contains Lactose Monohydrate 80.6mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet Off-white to light yellow, round, unscored tablet, engraved “APO” on one side and “PRA” over “20” on the other side 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 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 Pravastatin, secondary causes of hypercholesterolaemia should be excluded and patients should be placed on a standard lipid-lowering diet which should be continued during treatment. Posology 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 d Read the complete document