Maa: Irlanti
Kieli: englanti
Lähde: HPRA (Health Products Regulatory Authority)
Pravastatin sodium
McDermott Laboratories Ltd., T/A Gerard Laboratories
C10AA; C10AA03
Pravastatin sodium
40 milligram(s)
Tablet
Product subject to prescription which may be renewed (B)
HMG CoA reductase inhibitors; pravastatin
Not marketed
2010-12-17
PAGE 1 OF 7 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT PRAVASTATIN MYLAN 10 MG, 20 MG, 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 of the 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 Mylan is and what it is used for 2. What you need to know before you take Pravastatin Mylan 3. How to take Pravastatin Mylan 4. Possible side effects 5. How to store Pravastatin Mylan 6. Contents of the pack and other information 1. WHAT PRAVASTATIN MYLAN IS AND WHAT IT IS USED FOR Pravastatin, the active substance of Pravastatin Mylan, belongs to a group of medicines called statins which work by reducing high cholesterol levels in the blood. Cholesterol is a fatty substance (lipid) that can cause the narrowing of blood vessels in the heart causing coronary heart disease. Pravastatin Mylan is used - to lower high cholesterol levels in your blood if diet, exercise or weight loss has not lowered your cholesterol level - if you are at risk of narrowing of the blood vessels in your heart caused by too much cholesterol in your blood, as a supplement to your diet - to lower the fatty substances (lipids) in your blood if you have had an organ transplant - to reduce the chance of having another heart attack if you have previously had a heart attack or if you suffer from chest pain attacks (unstable angina pectoris) 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PRAVASTATIN MYLAN DO NOT TAKE PRAVASTATIN MYLAN - if you are allergic to pravastatin, or any of the other ingredients of this medicine (listed in section 6) - if you Lue koko asiakirja
Health Products Regulatory Authority 08 May 2023 CRN00DK8M Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Pravastatin Mylan 40 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 40 mg tablet contains 40 mg of pravastatin sodium. Excipient(s) with known effect Each 40 mg tablet contains 291.7 mg of lactose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet Pravastatin Mylan 40 mg tablets: Light pink colour, mottled, round tablet (10 mm) debossed with "40" on one side and break line on the other side. The tablet can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypercholesterolaemia 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 Posology Prior to initiating Pravastatin Mylan Tablets, secondary causes of hypercholesterolaemia should be excluded and patients should be placed on a standard lipid-lowering diet that should be continued during treatment. 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 Lue koko asiakirja