国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
Losartan potassium
Clonmel Healthcare Ltd
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
2007-09-14
Page 1 of 7 PACKAGE LEAFLET: INFORMATION FOR THE USER COZATAN 50MG FILM-COATED TABLETS COZATAN 100MG 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 your 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 Cozatan is and what it is used for 2. What you need to know before you take Cozatan 3. How to take Cozatan 4. Possible side effects 5. How to store Cozatan 6. Contents of the pack and other information 1. WHAT COZATAN 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. Cozatan 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 suita 阅读完整的文件
Health Products Regulatory Authority 12 November 2019 CRN009966 Page 1 of 13 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cozatan 50 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Cozatan 50 mg tablet contains 50 mg of losartan (as potassium salt). Excipient with known effect: Each Cozatan 50 mg tablet contains 115.8 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablets White round biconvex film-coated tablet with cross-score breaking notch on both sides. 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 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 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 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). Cozatan may be administered with other antihypertensive agents (see sections 4.3, 4.4, 4.5 and 5.1), especially with diuretics (e.g. hydrochlorothiazide). Paediatric populati 阅读完整的文件