Quốc gia: Vương quốc Anh
Ngôn ngữ: Tiếng Anh
Nguồn: MHRA (Medicines & Healthcare Products Regulatory Agency)
Losartan potassium
Dexcel-Pharma Ltd
C09CA01
Losartan potassium
50mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02050502; GTIN: 5033847001218
PACKAGE LEAFLET: INFORMATION FOR THE USER READ ALL OF THIS LEAFLET CAREFULLY BEFORE 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. 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. WHAT IS IN THIS LEAFLET: 1. What Losartan Tablets are and what they are used for 2. What you need to know before you take Losartan Tablets 3. How to take Losartan Tablets 4. Possible side effects 5. How to store Losartan Tablets 6. Contents of the pack and other information 1. WHAT LOSARTAN TABLETS ARE AND WHAT THEY ARE 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 Tablets are 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 suitable by your doctor. If your heart failure has b Đọc toàn bộ tài liệu
OBJECT 1 LOSARTAN POTASSIUM 50 MG FILM-COATED TABLETS Summary of Product Characteristics Updated 01-Mar-2018 | Dexcel Pharma Ltd 1. Name of the medicinal product Losartan potassium 50 mg film-coated tablets 2. Qualitative and quantitative composition Each Losartan potassium 50 mg Tablet contains 50 mg of losartan (as potassium salt). Each Losartan potassium 50 mg Tablet contains 115.8 mg lactose monohydrate. For a full list of excipients, see section 6.1. 3. Pharmaceutical form Film-coated tablet Losartan potassium 50 mg Tablets are supplied as a white, film-coated, round, biconvex tablets, quadrisected on one side. The tablet can be divided into equal quarters. 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 (see sections 4.3, 4.4, 4.5 and 5.1). • 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 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 Tablets may be adm Đọc toàn bộ tài liệu