국가: 아일랜드
언어: 영어
출처: HPRA (Health Products Regulatory Authority)
Pravastatin sodium
Norton Waterford
C10AA; C10AA03
Pravastatin sodium
10 milligram(s)
Tablet
Product subject to prescription which may be renewed (B)
HMG CoA reductase inhibitors; pravastatin
Marketed
2005-09-30
PACKAGE LEAFLET: INFORMATION FOR THE USER PRAVASTATIN SODIUM 10 MG, 20 MG, AND 40 MG TABLETS PRAVASTATIN 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 side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. WHAT PRAVASTATIN IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PRAVASTATIN 3. HOW TO TAKE PRAVASTATIN 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE PRAVASTATIN 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT PRAVASTATIN IS AND WHAT IT IS USED FOR Pravastatin belongs to a group of drugs called HMG-CoA reductase inhibitors. These reduce the amount of cholesterol and triglycerides (fatty substances) in your blood. Pravastatin is used: • to reduce your risk in the future of developing coronary heart disease or having a heart attack or stroke, if you have raised levels of cholesterol but do not have coronary heart disease • to reduce your risk of having a further heart attack or stroke, if you have already had a heart attack or have unstable angina • to reduce increased lipid levels, if you have had an organ transplant and are taking medication to stop your body rejecting the transplant. Some further information: • While cholesterol is vital for the normal functioning of the body, if the level in the blood becomes too high it can build up on the walls of the arteries. Eventually blood vessels can become blocked. Only a small amount of cholesterol comes from our diet, the majority is made by our own livers. The body produces most cholesterol at night. • Even though you may be on a low fat diet, your doctor has done some bloo 전체 문서 읽기
Health Products Regulatory Authority 24 May 2023 CRN00DJ3H Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Pravastatin Sodium 10 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains pravastatin sodium 10 mg. Excipients with known effect: Each tablet contains 52.72 mg lactose. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Tablet. Pink, mottled, round shallow convex tablet with breakline on both sides. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Hypercholesterolemia_ Treatment of primary hypercholesterolemia 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 hypercholesterolemia 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 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 is administered orally once daily preferably in the evening with or without food. A total daily dose of 40 mg should not be exceeded. _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 peri 전체 문서 읽기