Země: Velká Británie
Jazyk: angličtina
Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)
Losartan potassium
Milpharm Ltd
C09CA01
Losartan potassium
25mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02050502; GTIN: 8901175023196
PACKAGE LEAFLET: INFORMATION FOR THE USER LOSARTAN POTASSIUM 25 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 is and what it is used for 2. What you need to know before you take Losartan potassium 3. How to take Losartan potassium 4. Possible side effects 5. How to store Losartan potassium 6. Contents of the pack and other information 1. WHAT LOSARTAN POTASSIUM 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 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 Přečtěte si celý dokument
OBJECT 1 LOSARTAN POTASSIUM 25 MG FILM-COATED TABLETS Summary of Product Characteristics Updated 28-Jul-2017 | Aurobindo Pharma - Milpharm Ltd. 1. Name of the medicinal product Losartan potassium 25 mg film-coated tablets 2. Qualitative and quantitative composition Each Losartan potassium 25 mg tablet contains 25 mg of losartan potassium, equivalent to 22.9 mg of losartan. Excipient with known effect: Each Losartan potassium 25 mg tablet contains 20 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 '5' and '7' on either side of scoreline on one side and 'J' with a scoreline on other side. The tablet can be divided into equal doses. The size is 8.1 mm x 4.1 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 patients. The maximal antihypertensive effect is attained 3-6 weeks after initiation of therapy. Some patients may receive an addit Přečtěte si celý dokument