Страна: Ирландия
Език: английски
Източник: HPRA (Health Products Regulatory Authority)
Losartan potassium; Hydrochlorothiazide
Teva Pharma B.V.
C09DA; C09DA01
Losartan potassium; Hydrochlorothiazide
100 mg/25 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
Angiotensin II antagonists and diuretics; losartan and diuretics
Marketed
2008-01-25
1 PACKAGE LEAFLET: INFORMATION FOR THE USER LOSARTAN/HYDROCHLOROTHIAZIDE TEVA 50 MG/12.5 MG FILM-COATED TABLETS LOSARTAN/HYDROCHLOROTHIAZIDE TEVA 100 MG/25 MG FILM-COATED TABLETS losartan potassium/hydrochlorothiazide 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/Hydrochlorothiazide Teva tablets are and what they are used for 2. What you need to know before you take Losartan/Hydrochlorothiazide Teva tablets 3. How to take Losartan/Hydrochlorothiazide Teva tablets 4. Possible side effects 5. How to store Losartan/Hydrochlorothiazide Teva tablets 6. Contents of the pack and other information 1. WHAT LOSARTAN/HYDROCHLOROTHIAZIDE TEVA TABLETS ARE AND WHAT THEY ARE USED FOR Losartan and Hydrochlorothiazide is a combination of an angiotensin II receptor antagonist (losartan) and a diuretic (hydrochlorothiazide). 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. Hydrochlorothiazide works by making the kidneys pass more water and salt. This also helps to reduce blood pressure. Losartan/Hydrochlorothiazide Teva is indicated for the treatment of essential hypertension (high blood pressure). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LOSARTAN/HYDROCHLOROTHIAZIDE TEVA TABLETS DO NOT TAKE LOSARTAN/HYDROCHLOROTHIAZIDE TEVA TABLETS • i Прочетете целия документ
Health Products Regulatory Authority 09 February 2024 CRN00DXFS Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Losartan/Hydrochlorothiazide Teva 100mg/25mg Film-Coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 100 mg losartan potassium and 25 mg hydrochlorothiazide. Excipient with known effect Each tablet contains 270 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. 100/25MG: Yellow, oval, bi-convex tablets debossed 1 and 00 on one side and breakline on both sides. The tablet can be divided into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Losartan Hydrochlorothiazide is indicated for the treatment of essential hypertension in patients whose blood pressure is not adequately controlled on losartan or hydrochlorothiazide alone. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Hypertension_ Losartan and hydrochlorothiazide is not for use as initial therapy, but in patients whose blood pressure is not adequately controlled by losartan potassium or hydrochlorothiazide alone. Dose titration with the individual components (losartan and hydrochlorothiazide) is recommended. When clinically appropriate direct change from monotherapy to the fixed combination may be considered in patients whose blood pressure is not adequately controlled. The usual maintenance dose of Losartan Hydrochlorothiazide is one tablet of Losartan Hydrochlorothiazide 50 mg/12.5 mg (losartan 50 mg/HCTZ 12.5 mg) once daily. For patients who do not respond adequately to Losartan Hydrochlorothiazide 50 mg/12.5 mg, the dosage may be increased to one tablet of Losartan Hydrochlorothiazide 100 mg/25 mg (losartan 100 mg/HCTZ 25 mg) once daily. The maximum dose is one tablet of Losartan Hydrochlorothiazide 100 mg/25 mg once daily. In general, the antihypertensive effect is attained within three to four weeks after initiation of therapy. _ _ _Use in patients with renal impairment and haemodialysis patients_ No Прочетете целия документ