Land: Vereinigtes Königreich
Sprache: Englisch
Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)
Losartan potassium
Organon Pharma (UK) Ltd
C09CA01
Losartan potassium
12.5mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02050502; GTIN: 5013945002058
PATIENT INFORMATION LEAFLET COZAAR® 12.5MG 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. Your medicine is also available in the following strengths 25mg, 50mg and 100mg Tablets. WHAT IS IN THIS LEAFLET 1. What Cozaar is and what it is used for 2. What you need to know before you take Cozaar 3. How to take Cozaar 4. Possible side effects 5. How to store Cozaar 6. Contents of the pack and other information 1. WHAT COZAAR IS AND WHAT IT IS USED FOR Losartan (Cozaar) 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. Cozaar 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 use Lesen Sie das vollständige Dokument
OBJECT 1 COZAAR 12.5 MG FILM-COATED TABLETS Summary of Product Characteristics Updated 09-Apr-2018 | Merck Sharp & Dohme Limited 1. Name of the medicinal product Cozaar® 12.5 mg film-coated tablets Cozaar® 25 mg film-coated tablets Cozaar® 50 mg film-coated tablets Cozaar® 100 mg film-coated tablets 2. Qualitative and quantitative composition Each COZAAR 12.5 mg tablet contains 12.5 mg of losartan potassium. Each COZAAR 25 mg tablet contains 25 mg of losartan potassium. Each COZAAR 50 mg tablet contains 50 mg of losartan potassium. Each COZAAR 100 mg tablet contains 100 mg of losartan potassium. Each COZAAR 12.5 mg tablet contains 25.25 mg lactose monohydrate. Each COZAAR 25 mg tablet contains 12.75 mg lactose monohydrate. Each COZAAR 50 mg tablet contains 25.5 mg lactose monohydrate. Each COZAAR 100 mg tablet contains 51.0 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Film-coated tablets COZAAR 12.5 mg tablet Blue, oval film-coated tablets marked 11 on one side and plain on the other. COZAAR 25 mg tablet White, oval unscored film-coated tablets marked 951 on one side and plain on the other. COZAAR 50 mg tablet White, oval film-coated tablets marked 952 on one side and scored on the other. The score line is not intended for breaking the tablet. COZAAR 100 mg tablet White, teardrop-shaped film-coated tablets marked 960 on one side and plain on the other. 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 be Lesen Sie das vollständige Dokument