Country: Malta
Language: English
Source: Medicines Authority
HYDROCHLOROTHIAZIDE, VALSARTAN
Teva Pharma B.V. Swensweg 5, 2031 GA Haarlem, Netherlands
C09DA03
HYDROCHLOROTHIAZIDE 160 mg VALSARTAN 25 mg
FILM-COATED TABLET
HYDROCHLOROTHIAZIDE 160 mg VALSARTAN 25 mg
POM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
Withdrawn
2009-08-03
Page 1 of 8 PACKAGE LEAFLET: INFORMATION FOR THE USER VALSARTAN/HYDROCHLOROTHIAZIDE TEVA 80 MG/12.5 MG FILM-COATED TABLETS VALSARTAN/HYDROCHLOROTHIAZIDE TEVA 160 MG/25 MG FILM-COATED TABLETS Valsartan / Hydrochlorothiazide READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. - 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Valsartan / Hydrochlorothiazide is and what it is used for 2. Before you take Valsartan / Hydrochlorothiazide 3. How to take Valsartan / Hydrochlorothiazide 4. Possible side effects 5. How to store Valsartan / Hydrochlorothiazide 6. Further information 1. WHAT VALSARTAN / HYDROCHLOROTHIAZIDE IS AND WHAT IT IS USED FOR Valsartan/Hydrochlorothiazide film-coated tablets contain two active substances called valsartan and hydrochlorothiazide. 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 medicines called thiazide diuretics (also k Read the complete document
Page 1 of 16 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT [80 mg / 12.5 mg]: Valsartan/Hydrochlorothiazide Teva 80 mg/12.5 mg Film-coated Tablets [160 mg/25 mg]: Valsartan/Hydrochlorothiazide Teva 160 mg/25 mg Film-coated Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION [80 mg / 12.5 mg]: Each tablet contains 80 mg of valsartan and 12.5 mg of hydrochlorothiazide. [160 mg/25 mg]: Each tablet contains 160 mg valsartan and 25 mg hydrochlorothiazide. _Excipients _ _ _ [80 mg/12.5 mg]: Contains 0.029 mg sunset yellow FCF (E110). For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film coated tablet [80 mg / 12.5 mg]: Pink, film coated round tablet, debossed with "93" on one side and with "7428" on the other side of the tablet. [160 mg/25 mg]: Brown, film coated round tablet, debossed with "93" on one side and with "7430" on the other side of the tablet 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of essential hypertension in adults. Valsartan/Hydrochlorothiazide 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 _Posology _ The recommended dose of Valsartan/Hydrochlorothiazide is one film-coated tablet once daily. Dose titration with the individual components is recommended. In each case, up-titration of individual components to the next dose should be followed in order to reduce the risk of hypotension and other adverse events. When clinically appropriate direct change from monotherapy to the fixed combination may be considered in patients whose blood pressure is not adequately con Read the complete document