Country: আয়ার্লণ্ড
ভাষা: ইংরেজি
সূত্র: HPRA (Health Products Regulatory Authority)
Losartan potassium; Hydrochlorothiazide
Clonmel Healthcare Ltd
C09DA01
Losartan potassium; Hydrochlorothiazide
Film-coated tablet
losartan and diuretics
Not marketed
2023-01-27
Page 1 of 8 PACKAGE LEAFLET: INFORMATION FOR THE USER LOSARTAN/HYDROCHLOROTHIAZIDE CLONMEL 50 MG/12.5 MG FILM-COATED TABLETS LOSARTAN/HYDROCHLOROTHIAZIDE CLONMEL 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, pharmacist or nurse. • 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, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Losartan/Hydrochlorothiazide Clonmel is and what it is used for 2. What you need to know before you take Losartan/Hydrochlorothiazide Clonmel 3. How to take Losartan/Hydrochlorothiazide Clonmel 4. Possible side effects 5. How to store Losartan/Hydrochlorothiazide Clonmel 6. Contents of the pack and other information 1. WHAT LOSARTAN/HYDROCHLOROTHIAZIDE CLONMEL IS AND WHAT IT IS USED FOR Losartan/Hydrochlorothiazide Clonmel 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 Clonmel is indicated for the treatment of essential hypertension (high blood pressure). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LOSARTAN/HYDROCHLOROTHIAZIDE CLONMEL DO NOT TAKE LOSARTAN/HYDROCHLOROTHIAZIDE CLONMEL _• _ If সম্পূর্ণ নথি পড়ুন
Health Products Regulatory Authority 27 January 2023 CRN00CHQK Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Losartan/Hydrochlorothiazide Clonmel 100 mg/25 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 100 mg of losartan potassium and 25 mg of hydrochlorothiazide. Excipient with known effect Each film-coated tablet contains 157.9 mg of lactose (as monohydrate) For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet (tablet). Round, pale yellow film-coated tablet of around 10.5 mm in diameter. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Losartan/Hydrochlorothiazide Clonmel 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 Clonmel is one tablet of Losartan/Hydrochlorothiazide Clonmel 50 mg/12.5 mg (losartan potassium 50 mg/hydrochlorothiazide 12.5 mg) once daily. For patients who do not respond adequately to Losartan/Hydrochlorothiazide Clonmel 50 mg/12.5 mg, the dosage may be increased to one tablet of Losartan/Hydrochlorothiazide Clonmel 100 mg/25 mg (losartan potassium 100 mg/hydrochlorothiazide 25 mg) once daily. The maximum dose is one tablet of Losartan/Hydrochlorothiazide Clonmel 100 mg/25 mg once daily. In general, the antihypertensive effect is attained within three to four weeks after initiation of therapy. Lo সম্পূর্ণ নথি পড়ুন