País: Malta
Idioma: anglès
Font: Medicines Authority
LOSARTAN POTASSIUM
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom
C09CA01
LOSARTAN POTASSIUM 50 mg
FILM-COATED TABLET
LOSARTAN POTASSIUM 50 mg
POM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
Withdrawn
2005-06-30
Page 1 of 11 PACKAGE LEAFLET Page 2 of 11 PACKAGE LEAFLET: INFORMATION FOR THE USER COZAAR FILM-COATED TABLETS LOSARTAN POTASSIUM 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, pharmacist, or nurse. 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, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What COZAAR is and what it is used for 2. What you need to know before you take COZAAR 3. How to take COZAAR 4. Possible side effects 5. How to store COZAAR 6. Contents of the pack and other information 1. WHAT COZAAR IS AND WHAT IT IS USED FOR Losartan (COZAAR) belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body which binds to receptors in blood vessels, causing them to tighten. This results in an increase in blood pressure. Losartan prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax which in turn lowers the blood pressure. Losartan slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes. COZAAR is used to treat patients with high blood pressure (hypertension) in adults and in children and adolescents 6 – 18 years of age. to protect the kidney in hypertensive type 2 diabetic patients with laboratory evidence of impaired renal function and proteinuria ≥ 0.5 g per day (a condition in which urine contains an abnormal amount of protein). to treat patients with chronic heart failure when therapy with specific medicines called angiotensin-converting-enzyme inhibitors (ACE inhibitors, medicine used to lower high blood pressure) is not c Llegiu el document complet
Page 1 of 21 SUMMARY OF PRODUCT CHARACTERISTICS Page 2 of 21 1. NAME OF THE MEDICINAL PRODUCT COZAAR 12.5 mg film-coated tablets COZAAR 50 mg film-coated tablets COZAAR 100 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each COZAAR 12.5 mg tablet contains 12.5 mg of losartan potassium. Each COZAAR 50 mg tablet contains 50 mg of losartan potassium. Each COZAAR 100 mg tablet contains 100 mg of losartan potassium. Each COZAAR 12.5 mg tablet contains 25.25 mg lactose monohydrate. Each COZAAR 50 mg tablet contains 25.5 mg lactose monohydrate. Each COZAAR 100 mg tablet contains 51.0 mg lactose monohydrate. _ _ For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablets COZAAR 12.5 mg tablet Blue, oval film-coated tablets marked 11 on one side and plain on the other. COZAAR 50 mg tablet White, oval film-coated tablets marked 952 on one side and scored on the other. The score line is not intended for breaking the tablet. COZAAR 100 mg tablet White, teardrop-shaped film-coated tablets marked 960 on one side and plain on the other. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of essential hypertension in adults and in children and adolescents 6 – 18 years of age. Treatment of renal disease in adult patients with hypertension and type 2 diabetes mellitus with proteinuria ≥ 0.5 g/day as part of an antihypertensive treatment (see sections 4.3, 4.4, 4.5, and 5.1). Treatment of chronic heart failure in adult patients when treatment with Angiotensin- converting enzyme (ACE) inhibitors is not considered suitable due to incompatibility _, _ _especially cough, _ or contraindication. Patients with heart failure who have been stabilised with an ACE inhibitor should not be switched to losartan. The patients should have a left ventricular ejection fraction ≤ 40% and should be clinically stable and on an established treatment regimen for chronic heart failure. Reduction in the risk of stroke _ _ in adult hypertensive patients with left ventricula Llegiu el document complet