Šalis: Airija
kalba: anglų
Šaltinis: HPRA (Health Products Regulatory Authority)
Losartan potassium
KRKA, d.d., Novo mesto
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
2012-01-27
PACKAGE LEAFLET: INFORMATION FOR THE USER LOSARTAN KRKA 25 MG FILM-COATED TABLETS LOSARTAN KRKA 50 MG FILM-COATED TABLETS LOSARTAN KRKA 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. WHAT IS IN THIS LEAFLET 1. What Losartan Krka is and what it is used for 2. What you need to know before you take Losartan Krka 3. How to take Losartan Krka 4. Possible side effects 5. How to store Losartan Krka 6. Contents of the pack and other information 1. WHAT LOSARTAN KRKA 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 Krka 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 inhibitor Perskaitykite visą dokumentą
Health║Products║Regulatory║Authority 12║October║2021 CRN00CFPR Page║1║of║14 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Losartan║Krka║100║mg║film-coated║tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each║film-coated║tablet║contains 100║mg║losartan║potassium,║equivalent║to 91.5 mg║losartan. Excipient with known effect:║lactose║monohydrate ║ Losartan║Krka 100║mg║film-coated║tablets Lactose║monohydrate 109.3║ mg For the║ full║list║of║excipients,║see║section 6.1. 3 PHARMACEUTICAL FORM Film-coated║tablet White,║oval║(dimensions:║15 mm║x║8 mm),║light║biconvex║tablets. 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║strokein║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 Perskaitykite visą dokumentą