Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
LOSARTAN POTASSIUM
Laboratorios LICONSA, S.A.
LOSARTAN POTASSIUM
50 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Authorised
0000-00-00
PACKAGE LEAFLET: INFORMATION FOR THE USERFILM-COATED TABLETS LOSARTAN POTASSIUM READ ALL OF THIS LEAFLET CAREFULLY BEFORE TAKING THIS MEDICINE. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or your pharmacist. • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What read_full_documentis and what it is used for 2. Before you take 3. How to take 4. Possible side effects 5. How to store 6. Further information 1. WHAT 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 is used • to treat patients with high blood pressure (hypertension) • 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
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Losartan Potassium Liconsa 50 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Losartan Potassium Liconsa contains 50 mg of the active ingredient losartan potassium. Excipients: Lactose monohydrate 25.50 mg and other excipients. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablets. Round, white, film-coated tablets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Treatment of essential hypertension. • 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 chronic 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 Losartan tablets should be swallowed with a glass of water. Losartan Potassium Liconsa may be administered with or without food. 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 Potassium Liconsa may be administered with other antihypertensive agent read_full_document