국가: 아르메니아
언어: 영어
출처: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
losartan (losartan potassium), hydrochlorothiazide
Denk Pharma GmbH & Co. KG
C09DA01
losartan (losartan potassium), hydrochlorothiazide
50mg+ 12,5mg
tablets film-coated
(28/2x14/) in blister
Prescription
Registered
2022-05-03
_CoLosar-Denk 50/12.5_ Film-coated tablet – oral use Angiotensin II receptor antagonist and diuretic Active substances: losartan + hydrochlorothiazide (HCT) Package leaflet: Information for the patient 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 COLOSAR-DENK 50/12.5 IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE COLOSAR-DENK 50/12.5 3. HOW TO TAKE COLOSAR-DENK 50/12.5 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE COLOSAR-DENK 50/12.5 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. What CoLosar-Denk 50/12.5 is and what it is used for CoLosar-Denk 50/12.5 is a combination of an angiotensin II receptor antagonist (losartan) and a diuretic (hydrochlorothiazide). The substance angiotensin II is formed in the body and helps to regulate the blood pressure. It binds to receptors in blood vessels, causing them to tighten. This results in an increase in blood pressure. When blood pressure is high, angiotensin II plays a part in maintaining the elevated 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. CoLosar-Denk 50/12.5 is indicated for the treatment of high blood pressure (essential hypertension). 2. What you need to know before you take CoLosar-Denk 50/12.5 Do not take CoLosar-Denk 50/12.5 • if you are allergic to losartan, hydrochlorothiazide or 전체 문서 읽기
1 S UMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT CoLosar-Denk 50/12.5 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substances: losartan and hydrochlorothiazide Each film-coated tablet contains 50 mg losartan potassium equivalent to 45.76 mg losartan and 12.5 mg hydrochlorothiazide (HCT). Excipient with known effect: Each film-coated tablet contains 25 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet Yellow coloured, round, biconvex, film-coated tablets, imprint “CoLos” on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS CoLosar-Denk 50/12.5 is indicated for the treatment of essential hypertension in patients whose blood pressure cannot be adequately controlled on losartan or hydrochlorothiazide alone. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Hypertension Losartan/HCT is not suitable for use as initial treatment, but for the treatment of patients whose blood pressure is not adequately controlled on losartan potassium or hydrochlorothiazide alone. Dosage titration with the individual components (losartan and hydrochlorothiazide) is recommended. Where clinically appropriate, a 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 CoLosar-Denk 50/12.5 (50 mg losartan potassium and 12.5 mg HCT) once daily. For patients who do not respond adequately, this dose may be increased to 2 tablets of CoLosar- Denk 50/12.5 (100 mg losartan potassium and 25 mg HCT) once daily. The maximum dose is two tablets of CoLosar-Denk 50/12.5 once daily. In general, the blood pressure lowering effect is attained within three to four weeks after the commencement of therapy. 2 Use in patients with renal impairment and haemodialysis patients No initial dosage adjustment is necessary in patients with moderate renal impairment (i.e. creatinine clearance of 30-50 ml/min). Losartan/HCT tablets are not 전체 문서 읽기