Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Losartan potassium
Teva Pharma B.V.
C09CA; C09CA01
Losartan potassium
100 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
Angiotensin II antagonists, plain; losartan
Marketed
2008-06-20
ZONA SEGURIDAD EN BLANCO 10 MM. ZONA SEGURIDAD EN BLANCO 10 MM. ZONA SEGURIDAD EN BLANCO 10 MM. ZONA SEGURIDAD EN BLANCO 10 MM. Losartan Teva 50 mg Film-coated Tablets Losartan Teva 100 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. • 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. 1. WHAT LOSARTAN TEVA IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LOSARTAN TEVA 3. HOW TO TAKE LOSARTAN TEVA 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE LOSARTAN TEVA 6. CONTENTS OF THE PACK AND OTHER INFORMATION WHAT LOSARTAN TEVA IS AND WHAT IT IS USED FOR Losartan Teva 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 Teva prevents the binding of angiotensin- II to these receptors, causing the blood vessels to relax which in turn lowers the blood pressure. Losartan Teva slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes. Losartan Teva 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 angiotens Les hele dokumentet
Health║Products║Regulatory║Authority 31║October║2019 CRN0098ZH Page║1║of║14 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Losartan║Teva║100║mg║Film-coated║Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each║tablet║contains║100║mg║of║losartan║potassium,║equivalent║to║91.6║mg║of║losartan. _Excipient with known effect:_ Each║tablet║contains║18.0║mg║of║lactose║monohydrate. For the║full║list║of║excipients,║see║section║6.1. 3 PHARMACEUTICAL FORM Film-coated║tablet. White,║oval,║slightly║arched║film-coated║tablets,║debossed║“100”║on║one║side,║scoreline║on║the║other. The║tablets║can║be║divided║into║equal║doses. 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 POSO Les hele dokumentet