Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
Losartan potassium; Hydrochlorothiazide
Rowex Ltd
C09DA; C09DA01
Losartan potassium; Hydrochlorothiazide
50 mg/12.5 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
Angiotensin II antagonists and diuretics; losartan and diuretics
Not marketed
2009-03-20
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT LOSARTAN/HYDROCHLOROTHIAZIDE 50 MG/ 12.5 MG FILM-COATED TABLETS LOSARTAN/HYDROCHLOROTHIAZIDE 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 is and what it is used for 2. What you need to know before you take Losartan/Hydrochlorothiazide 3. How to take Losartan/Hydrochlorothiazide 4. Possible side effects 5. How to store Losartan/Hydrochlorothiazide 6. Contents of the pack and other information 1. WHAT LOSARTAN/HYDROCHLOROTHIAZIDE IS AND WHAT IT IS USED FOR_ _ _Losartan_ potassium belongs to a group of medicines called angiotensin-II receptor antagonists. These cause the blood vessels to relax which in turn lowers the blood pressure. _Hydrochlorothiazide_ belongs to a group of medicines called diuretics (water tablets). Hydrochlorothiazide works by making the kidneys pass more water and salt. This also helps to reduce blood pressure. _Losartan/Hydrochlorothiazide 50 mg/12.5 mg film-coated tablets: _ These tablets are used to treat high blood pressure. The combination of losartan and hydrochlorothiazide is a suitable alternative for those people who would otherwise have to be treated with losartan potassium and hydrochlorothiazide given as separate tablets. _Losartan/Hydrochlorothiazide 100 mg/ 25 mg film-coated tablets: _ These tablets are used to treat high blood pressure in patients who have not responded sufficiently to treatment with Losartan/Hy Прочитать полный документ
Health Products Regulatory Authority 30 June 2021 CRN00CD2Q Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Losartan/Hydrochlorothiazide 50 mg/ 12.5 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 50 mg of losartan potassium and 12.5 mg hydrochlorothiazide. Excipient with known effect Each film-coated tablet contains 25.6 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet Light yellow, round, biconvex film-coated tablet with a diameter of 8 mm. 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 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 dose may be increased to maximum 2 tablets daily of Losartan/Hydrochlorothiazide 50 mg/ 12.5 mg or one tablet of Losartan/Hydrochlorothiazide 100 mg/ 25 mg (losartan 100 mg/ HCTZ 25 mg) once daily. In general, the antihypertensive effect is attained within three to four weeks after initiation of therapy. _Renal impairment and haemodialysis_ No initial dose adjustment is necessary in patients with moderate renal impairment (i.e. creatinine clearance 30-50 ml/mi Прочитать полный документ