Maa: Irlanti
Kieli: englanti
Lähde: HPRA (Health Products Regulatory Authority)
Losartan potassium
Merck Sharp & Dohme Ireland (Human Health) Limited
C09CA; C09CA01
Losartan potassium
12.5 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
Angiotensin II antagonists, plain; losartan
Marketed
2009-03-06
PACKAGE LEAFLET: INFORMATION FOR THE USER COZAAR® 12.5MG FILM-COATED TABLETS COZAAR® 50MG FILM-COATED TABLETS COZAAR® 100MG 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 Lue koko asiakirja
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cozaar 12.5mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each COZAAR 12.5 mg tablet contains 12.5 mg of losartan potassium. Each COZAAR 12.5 mg tablet contains 25.25 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. 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 ventricular hypertrophy documented by ECG (see section 5.1 LIFE study, Race). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Hypertension The usual starting and maintenance dose is 50 mg once daily for most patients. The maximal antihypertensive effect is attained 3-6 weeks after initiation of therapy. Some patients may receive an additional benefit by increasing the dose to 100 mg once daily (in the morning). Losartan may be administered with other antihypertensive agents, especially with diuretics (e.g. hydrochlorothiazide) (see sections 4.3, 4.4, 4.5, and 5.1). Hypertensive type II diabetic patients with proteinuria 0.5 g/day The usual starting dose is 50 Lue koko asiakirja