Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
Losartan potassium
Accord Healthcare Limited
C09CA; C09CA01
Losartan potassium
50 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
Angiotensin II antagonists, plain; losartan
Marketed
2009-04-08
PACKAGE LEAFLET: INFORMATION FOR THE USER LOSARTAN POTASSIUM 25 MG FILM-COATED TABLETS LOSARTAN POTASSIUM 50 MG FILM-COATED TABLETS LOSARTAN POTASSIUM 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, 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 Losartan Potassium Tablets is and what it is used for 2. What you need to know before you take Losartan Potassium Tablets 3. How to take Losartan Potassium Tablets 4. Possible side effects 5. How to store Losartan Potassium Tablets 6. Contents of the pack and other information 1. WHAT LOSARTAN POTASSIUM TABLETS 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 prevent the effect of angiotensin-II, causing the blood vessels to relax which in turn lowers your blood pressure. Losartan slows the decrease of kidney function in patients with high blood pressure and type II diabetes. Losartan Potassium is used to treat patient with high blood pressure (hypertension) in adults and in children and adolescents 6-18 years of age to protect the kidney in hypertensive type II 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 w Baca dokumen lengkap
Health Products Regulatory Authority 05 October 2018 CRN008L3R Page 1 of 24 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Losartan Potassium 50 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 50 mg of losartan potassium, equivalent to 45.8mg of Losartan. Excipient: 52mg of lactose/film-coated tablet. For the full list of excipients see section 6.1 3 PHARMACEUTICAL FORM Film-coated tablet White to off white, round, biconvex, film-coated tablets with breakline on one side and “50” debossing on other side. The break line is only to facilitate breaking for ease of swallowing and not to divide 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 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 hypertensive patients with left ventricular hypertrophy documented by ECG (see section 5.1 LIFE study, Race). Health Products Regulatory Authority 05 October 2018 CRN008L3R Page 2 of 24 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 Baca dokumen lengkap