Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
Losartan potassium
Accord Healthcare Ireland Ltd.
C09CA; C09CA01
Losartan potassium
100 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
Angiotensin II antagonists, plain; losartan
Not marketed
2006-06-02
V027 June 2017 PACKAGE LEAFLET: INFORMATION FOR THE USER COSARTAL 50 MG FILM-COATED TABLETS COSARTAL 100 MG FILM-COATED TABLETS Losartan Potassium READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have further questions, ask your doctor or 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 COSARTAL IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE COSARTAL 3. HOW TO TAKE COSARTAL 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE COSARTAL 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT COSARTAL IS AND WHAT IT IS USED FOR Cosartal 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. Cosartal prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax which in turn lowers the blood pressure. Cosartal slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes. Cosartal 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 function 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 no Прочитать полный документ
Health║Products║Regulatory║Authority 12║November║2018 CRN008M9J Page║1║of║25 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cosartal║100║mg║Film-coated║tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each║film-coated║tablet║contains║100 mg║of║losartan║potassium For║a║full║list║of║excipients,║see║Section║6.1║ 3 PHARMACEUTICAL FORM Film-coated║tablet. White,║oval,║biconvex,║scored,║film-coated║tablets║marked║4L║on║one║side. The║tablet║can║be║divided║into║equal║halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cosartal║is║indicated║for║the:║ – ║Treatment║of║essential║hypertension║in║adults║and║in║children║and║adolescents║6-18 years║of║age.║ – ║Treatment║of║renal║disease║in║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║5 Прочитать полный документ