Krajina: Arménsko
Jazyk: angličtina
Zdroj: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
valsartan, hydrochlorothiazide
Denk Pharma GmbH & Co. KG
valsartan, hydrochlorothiazide
80mg+12,5mg
tablets film-coated
Prescription
_CoValsar-Denk 80/12.5_ Film-coated tablet – oral use Angiotensin II antagonist and diuretic Active substances: Valsartan + Hydrochlorothia- zide (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 of the side effects, talk to your doctor or pharmacist. This includes any pos- sible side effects not listed in this leaflet. See section 4. What is in this leaflet 1. WHAT COVALSAR-DENK IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE COVALSAR-DENK 3. HOW TO TAKE COVALSAR-DENK 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE COVALSAR-DENK 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. What CoValsar-Denk is and what it is used for CoValsar-Denk film-coated tablets contain two ac- tive substances called valsartan and hydrochloro- thiazide. Both of these substances help to control high blood pressure (hypertension). • VALSARTAN belongs to a class of medicines known as “angiotensin II receptor antagonists”, which help to control high blood pressure. Angiotensin II is a substance in the body that causes vessels to tighten, thus causing your blood pressure to increase. Valsartan works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure is lowered. • HYDROCHLOROTHIAZIDE belongs to a group of med- icines called thiazide diuretics (also known as “water tablets”). Hydrochlorothiazide increases urine output, which also lowers blood pressure. CoValsar-Denk is used to treat high blood pressure which is not adequately controlled by a single sub- stance alone. High blood pressure increases the workload of the heart and arteries. If not treated, it can da Prečítajte si celý dokument
1 SUMMARY OF THE PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT CoValsar-Denk 80/12.5 CoValsar-Denk 160/12.5 CoValsar-Denk 320/12.5 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substances: valsartan and hydrochlorothiazide CoValsar-Denk 80/12.5 Each tablet contains 80 mg of valsartan and 12.5 mg of hydrochlorothiazide. Excipient with known effect: each 80 mg/12.5 mg film-coated tablet contains 0.135 mg of soya leci- thin. CoValsar-Denk 160/12.5 Each tablet contains 160 mg of valsartan and 12.5 mg of hydrochlorothiazide. Excipient with known effect: each 160 mg/12.5 mg film-coated tablet contains 0.270 mg of soya leci- thin. CoValsar-Denk 320/12.5 Each tablet contains 320 mg of valsartan and 12.5 mg of hydrochlorothiazide. Excipient with known effect: each 320 mg/12.5 mg film-coated tablet contains 0.540 mg of soya leci- thin. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. CoValsar-Denk 80 mg/12.5 mg film-coated tablets are pink, biconvex and oval-shaped. CoValsar-Denk 160 mg/12.5 mg film-coated tablets are dark-red, biconvex and oval-shaped. CoValsar-Denk 320 mg/12.5 mg film-coated tablets are pink, biconvex and oval-shaped. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of essential hypertension in adults. CoValsar-Denk fixed-dose combination is indicated in patients whose blood pressure is not adequately controlled on valsartan or hydrochlorothiazide monotherapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION 2 Posology The recommended dose of CoValsar-Denk 80 mg/12.5 mg is one film-coated tablet once daily. Dose titration with the individual components is recommended. In each case, up-titration of individual com- ponents to the next dose should be followed in order to reduce the risk of hypotension and other ad- verse events. When clinically appropriate direct change from monotherapy to the fixed combination may be consi- dered in patients whose blood pressure is not adequately controlled on valsartan or hydrochlorothi- azide monotherapy, Prečítajte si celý dokument