Страна: Малта
Език: английски
Източник: Medicines Authority
LOSARTAN POTASSIUM
Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland
C09CA01
LOSARTAN POTASSIUM 50 mg
FILM-COATED TABLET
LOSARTAN POTASSIUM 50 mg
POM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
Withdrawn
2006-12-05
PACKAGE LEAFLET: INFORMATION FOR THE USER LOPRESS 50 MG 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 Lopress is and what it is used for 2. What you need to know before you take Lopress 3. How to take Lopress 4. Possible side effects 5. How to store Lopress 6. Contents of the pack and other information 1. WHAT LOPRESS IS AND WHAT IT IS USED FOR Lopress contains the active substance losartan which 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. Lopress 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 considered s Прочетете целия документ
1. NAME OF THE MEDICINAL PRODUCT Lopress 50 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each Lopress 50 mg film-coated tablet contains 50 mg of losartan (as potassium salt). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet White, round, biconvex, scored, diameter 10mm, film-coated tablets marked 3L on one side. The tablet can be divided into equal doses. 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 patients with hypertension and type 2 diabetes mellitus with proteinuria ≥ 0.5 g/day as part of an antihypertensive treatment. - Treatment of chronic heart failure (in patients ≥ 60 years), when treatment with 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 stabilised under the treatment of the heart failure. - Reduction in the risk of stroke in 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). Lopress may be administered with other antihypertensive agents, especially with diuretics (e.g. hydrochlorothiazide). (see sections 4.3, 4.4, 4.5 and 5.1). _Paediatric population _ There are limited data on the efficacy and safety of losartan in children and adolescents aged 6-18 years old for the treatment of hypertension (see section 5.1). Limited pharmacokinetic data are Прочетете целия документ