البلد: أيرلندا
اللغة: الإنجليزية
المصدر: HPRA (Health Products Regulatory Authority)
Losartan potassium
Clonmel Healthcare Ltd
C09DA01
Losartan potassium
Film-coated tablet
losartan and diuretics
Not marketed
2023-01-06
Page 1 of 7 PACKAGE LEAFLET: INFORMATION FOR THE USER LOSARTAN CLONMEL 50 MG FILM-COATED TABLETS LOSARTAN CLONMEL 100 MG FILM-COATED TABLETS losartan potassium READ ALL OF THIS LEAFLET CAREFULLY, BEFORE YOU START GIVING 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 possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Losartan Clonmel is and what it is used for 2. What you need to know before you give Losartan Clonmel 3. How to take Losartan Clonmel 4. Possible side effects 5. How to store Losartan Clonmel 6. Contents of the pack and other information 1. WHAT LOSARTAN CLONMEL IS AND WHAT IT IS USED FOR Losartan Clonmel 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. Losartan Clonmel 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 inhibi اقرأ الوثيقة كاملة
Health Products Regulatory Authority 10 January 2023 CRN00CKF8 Page 1 of 13 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Losartan Clonmel 100 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 100 mg losartan potassium. Excipient with known effect Each film coated tablet contains 48.5 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet White, round (9.3 mm in diameter) film-coated tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Losartan Clonmel is indicated in the treatment of essential hypertension in adults and in children and adolescents 6 - 18 years of age. Losartan Clonmel is indicated in the 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). Losartan Clonmel is indicated in the 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. Losartan Clonmel is also indicated for 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 اقرأ الوثيقة كاملة