Země: Irsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
PRAVASTATIN SODIUM
Accord Healthcare Limited
C10AA03
PRAVASTATIN SODIUM
40 Milligram
Tablets
Product subject to prescription which may be renewed (B)
pravastatin
Marketed
2008-09-26
Pravastatin Sodium Tablets Module 1 APPENDIX-8 PRAVASTATIN SODIUM TABLETS (PIL-ENGLISH-CLEAN) Pravastatin Sodium Tablets Module 1 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 Přečtěte si celý dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Pravastatin Sodium 40 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 40 mg pravastatin sodium. Excipient: Lactose monohydrate 286.62 mg. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. Pravastatin Tablets 40 mg: Yellow colored, rounded rectangular shaped, biconvex, uncoated tablets debossed ‘PDT’ on one side and ‘40’ 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). 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. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ Přečtěte si celý dokument