Šalis: Airija
kalba: anglų
Šaltinis: HPRA (Health Products Regulatory Authority)
Losartan potassium
Organon Pharma (Ireland) Limited
C09CA; C09CA01
Losartan potassium
12.5 milligram(s)
Film-coated tablet
Angiotensin II antagonists, plain; losartan
Marketed
2009-03-06
PACKAGE LEAFLET: INFORMATION FOR THE USER COZAAR® 12.5MG FILM-COATED TABLETS COZAAR® 50MG FILM-COATED TABLETS COZAAR® 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, 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 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 used to Perskaitykite visą dokumentą
Health║Products║Regulatory║Authority 18║May║2022 CRN00CRL7 Page║1║of║15 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cozaar║12.5mg║Film-coated║Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each║COZAAR║12.5 mg║tablet║contains║12.5 mg║of║losartan║potassium. Each║COZAAR║12.5 mg║tablet║contains║25.25║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.║ 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║maintenanc Perskaitykite visą dokumentą