Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
LOSARTAN POTASSIUM
Milpharm Limited
C09CA01
LOSARTAN POTASSIUM
50 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Angiotensin II antagonists, plain
Authorised
2014-11-28
PACKAGE LEAFLET: INFORMATION FOR THE USER LOSARTAN POTASSIUM MILPHARM 50 MG FILM-COATED TABLETS LOSARTAN POTASSIUM MILPHARM 100 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 or 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 or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Losartan potassium Milpharm is and what it is used for 2. What you need to know before you take Losartan potassium Milpharm 3. How to take Losartan potassium Milpharm 4. Possible side effects 5. How to store Losartan potassium Milpharm 6. Contents of the pack and other information 1. WHAT LOSARTAN POTASSIUM MILPHARM IS AND WHAT IT IS USED FOR Losartan 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 potassium Milpharm 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 abnorma Lestu allt skjalið
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Losartan potassium Milpharm 50 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Losartan potassium Milpharm 50 mg tablet contains 50 mg of losartan potassium, equivalent to 45.8 mg of losartan. Excipient with known effect: Each Losartan potassium Milpharm 50 mg tablet contains 40 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet White to off-white, oval shaped, biconvex film-coated tablets debossed with ‘E’ on one side and ‘4’ and ‘6’ separated by score line on the other side. The tablet can be divided into equal doses. The size is 10.3 mm x 5.4 mm. 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. 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 Lestu allt skjalið