Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Losartan potassium
Wockhardt UK Limited
C09CA; C09CA01
Losartan potassium
50 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
Angiotensin II antagonists, plain; losartan
Not marketed
2011-10-07
CHANGE CONTROL : Version changes due to change in: Size/Layout Regulatory Non-Regulatory Changes in detail: • New regulatory text 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 Potassium Tablets are and what they are used for 2. What you need to know before you take Losartan Potassium Tablets 3. How to take Losartan Potassium Tablets 4. Possible side effects 5. How to store Losartan Potassium Tablets 6. Contents of the pack and other information 1. WHAT LOSARTAN POTASSIUM TABLETS ARE AND WHAT THEY ARE 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 blood vessels to relax which in turn lowers the blood pressure. Losartan slows the decrease of kidneys function in patients with high blood pressure and type 2 diabetes. Losartan Potassium Tablets are used • to treat patients with high blood pressure (hypertension) in adults, and in children and adolescents between 6 - 18 years of age • to protect the kidneys in hypertensive type 2 diabetic patients with laboratory evidence of impaired renal function and proteinuria ≥ 0.5g per day (a condition in which the urine contains an abnormal amount of protein) • to treat patients with chronic heart failure when therapy with specific medicines called angiot Read the complete document
Health║Products║Regulatory║Authority 28║September║2018 CRN008L3N Page║1║of║23 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Losartan║Potassium║50mg║Film-Coated║Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each║tablet║contains║50 mg║of║losartan║potassium,║equivalent║to║45.8mg║of║losartan. Excipient with known effect: Lactose║(anydrous)║–║30mg║per║tablet. For║the║full║list║of║excipients,║see║section 6.1. 3 PHARMACEUTICAL FORM Film║coated║tablets. White,║oval-shaped,║film-coated║tablets║with║a║central║break║line║on║one║side║and║ plain║on║the║other║side. ║The║scoreline║is║only║to║facilitate║breaking║for║ease║of║ swallowing║and║not║to║divide║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║strokein║adult║hypertensive║patients║with║left║ventricular║ hypertrophy║do Read the complete document