Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
PRAVASTATIN SODIUM
Milpharm Limited
C10AA03
PRAVASTATIN SODIUM
10 Milligram
Tablets
Product subject to prescription which may be renewed (B)
HMG CoA reductase inhibitors
Authorised
2012-08-31
PACKAGE LEAFLET: INFORMATION FOR THE USER PRAVASTATIN SODIUM AUROBINDO 10 MG TABLETS PRAVASTATIN SODIUM AUROBINDO 20 MG TABLETS PRAVASTATIN SODIUM AUROBINDO 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 Pravastatin sodium Aurobindo is and what it is used for 2. What you need to know before you take Pravastatin sodium Aurobindo 3. How to take Pravastatin sodium Aurobindo 4. Possible side effects 5. How to store Pravastatin sodium Aurobindo 6. Contents of the pack and other information 1. WHAT PRAVASTATIN SODIUM AUROBINDO IS AND WHAT IT IS USED FOR Pravastatin sodium Aurobindo 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 infarctio Preberite celoten dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Pravastatin sodium Aurobindo 10mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg pravastatin sodium. Excipient with known effect Each tablet contains 67.01 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet Yellow, capsule shaped, biconvex, mottled, uncoated tablets with notched sides at double bisect, debossed with a “Y” on one side and “60” on other side. The size is 8.9 mm X 4.5 mm. The tablet can be divided 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 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 Posology Prior to initiating Pravastatin sodium Aurobindo, secondary causes of hypercholesterolaemia should be excluded and patients should be placed on a standard lipid-lowering diet which should be continued during treatment. Preberite celoten dokument