Страна: Малта
Език: английски
Източник: Medicines Authority
PRAVASTATIN SODIUM
Accord Healthcare Ireland Ltd Euro House, Euro Business Park, Little Island Cork, T45 K857, Ireland
C10AA03
PRAVASTATIN SODIUM 10 mg
TABLET
PRAVASTATIN SODIUM 10 mg
POM
LIPID MODIFYING AGENTS
Withdrawn
2009-11-19
PAGE 1 OF 6 PACKAGE LEAFLET: INFORMATION FOR THE USER PRAVASTATIN SODIUM 10 MG TABLETS PRAVASTATIN SODIUM 20 MG TABLETS PRAVASTATIN SODIUM 40 MG 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 further questions, please 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 Pravastatin Sodium Tablets is and what it is used for 2. Before you take Pravastatin Sodium Tablets 3. How to take Pravastatin Sodium Tablets 4. Possible side effects 5. How to store Pravastatin Sodium Tablets 6. Further information 1. WHAT PRAVASTATIN SODIUM TABLETS IS AND WHAT IT IS USED FOR Pravastatin Sodium Tablets 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 block them. This condition is called hardening of the arteries or atherosclerosis, may lead to: • chest pain (angina pectoris), when a blood vessels in the heart is partially blocked, • a heart attack (myocardial infraction), when a blood vessels 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 Pravastatin Sodium Tablets 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 Прочетете целия документ
Page 1 of 13 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Pravastatin Sodium 10 mg Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg pravastatin sodium. Excipient: Lactose monohydrate 71.65 mg. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. Pravastatin Tablets 10 mg: Yellow colored, rounded rectangular shaped, biconvex, uncoated tablets debossed ‘PDT’ on one side and ‘10’ 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 (eg. 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-patient receiving immunosuppressive therapy following solid organ transplantation (see sections 4.2, 4.5 and 5.1). Page 2 of 13 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Prior to initiating Pravastatin Tablets, secondary causes of hypercholesterolaemia should be excluded and patients should be placed on a standard lipid-lowering diet, which should be continued during treatment. Pravastatin sodium 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 l Прочетете целия документ