Država: Armenija
Jezik: engleski
Izvor: 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
2016-10-26
_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 user READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMA- TION 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 mg is a combination of an angi- otensin II receptor antagonist (losartan) and a diuretic (hydrochlorothiazide). CoLosar- Denk 50/12.5 is used in the treatment of essential hypertension (high blood pressure). If you have any questions about how CoLosar- Denk 50/12.5 works or why this medicine has been prescribed for you, ask your doctor. 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 (hypersensitive) to losartan, hydro- chlorothiazide or any of the other ingredients of this medicine (listed in section 6), • if you are allergic (hypersensitive) to preparations containing sulphonamide (e.g. other thiazides, some antibiotics such as cotrimoxazole; please ask your doctor if you are not sure), • if you are pregnant or breast-feeding (see also section “Pregnancy and breast feeding”), • if your liver function is seriously impaired, Pročitajte cijeli dokument
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. 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 recommended for patients receiving haemodialysis. Losartan/HCT Pročitajte cijeli dokument