Land: Malta
Språk: engelsk
Kilde: Medicines Authority
HYDROCHLOROTHIAZIDE; VALSARTAN
Novartis Pharmaceuticals UK Limited
C09DA03
HYDROCHLOROTHIAZIDE; VALSARTAN
FILM-COATED TABLET
HYDROCHLOROTHIAZIDE 25 mg; VALSARTAN 320 mg
POM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
Authorised
2007-03-09
PACKAGE LEAFLET: INFORMATION FOR THE USER CO-DIOVAN 80 MG/12.5 MG FILM-COATED TABLETS CO-DIOVAN 160 MG/12.5 MG FILM-COATED TABLETS CO-DIOVAN 160 MG/25 MG FILM-COATED TABLETS CO-DIOVAN 320 MG/12.5 MG FILM-COATED TABLETS CO-DIOVAN 320 MG/25 MG FILM-COATED TABLETS Valsartan/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 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 Co-Diovan is and what it is used for 2. What you need to know before you take Co-Diovan 3. How to take Co-Diovan 4. Possible side effects 5. How to store Co-Diovan 6. Contents of the pack and other information 1. WHAT CO-DIOVAN IS AND WHAT IT IS USED FOR Co-Diovan 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 known as “water tablets”). Hydrochlorothiazide increases urine output, which also lowers blood pressure. Co-Diovan is used to treat high blood pressure which is not adequately controlled by a single substance alone. High blood pressure increases the workload of read_full_document
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Co-Diovan 80 mg/12.5 mg film-coated tablets Co-Diovan 160 mg/12.5 mg film-coated tablets Co-Diovan 160 mg/25 mg film-coated tablets Co-Diovan 320 mg/12.5 mg film-coated tablets Co-Diovan 320 mg/25 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 80 mg of valsartan and 12.5 mg of hydrochlorothiazide. Each film-coated tablet contains 160 mg of valsartan and 12.5 mg of hydrochlorothiazide Each film-coated tablet contains 160 mg of valsartan and 25 mg of hydrochlorothiazide. Each film-coated tablet contains 320 mg of valsartan and 12.5 mg of hydrochlorothiazide. Each film-coated tablet contains 320 mg of valsartan and 25 mg of hydrochlorothiazide. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablets. 80 mg/12.5 mg: Light orange, ovaloid tablet imprinted with HGH on one side and CG on the other side. 160 mg/12.5 mg: Dark red, ovaloid tablet imprinted with HHH on one side and CG on the other side. 160 mg/25 mg: Brown, ovaloid tablet imprinted with HXH on one side and NVR on the other side. 320 mg/12.5 mg: Pink, ovaloid shaped, beveled edge tablet, imprinted with NVR on one side and HIL on the other side. 320 mg/25 mg: Yellow, ovaloid shaped, beveled edge tablet, imprinted with NVR on one side and CTI on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of essential hypertension in adults. Co-Diovan 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 Co-Diovan 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 monother read_full_document