País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
Valsartan; Hydrochlorothiazide
PCO Manufacturing Ltd.
C09DA03
Valsartan; Hydrochlorothiazide
320 mg/12.5 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
valsartan and diuretics
Authorised
2013-04-12
_ _ _ _ _ _ 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 Leia o documento completo
Health Products Regulatory Authority 15 March 2019 CRN008WLC Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Co-Diovan 320 mg/12.5 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 320 mg of valsartan and 12.5 mg of hydrochlorothiazide. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated Tablet _Product imported from Italy:_ Pink, ovaloid shaped, beveled edge tablets, imprinted with “NVR” on one side and “HIL” on the other side. 4 CLINICAL PARTICULARS As per PA0896/007/004 5 PHARMACOLOGICAL PROPERTIES As per PA0896/007/004 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS _Tablet core:_ Microcrystalline cellulose Silica, Colloidal anhydrous Crospovidone Magnesium stearate _Coating:_ Hypromellose Macrogol 4000 Talc Titanium dioxide (E171) Black iron oxide (E172) Red iron oxide (E172) 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf-life expiry date of this product shall be the date shown on the blister and on the outer carton. 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not store above 30 °C. Store in the original package in order to protect from moisture. Health Products Regulatory Authority 15 March 2019 CRN008WLC Page 2 of 2 6.5 NATURE AND CONTENTS OF CONTAINER Blisters: 28 (calendar pack) film-coated tablets in a carton. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCT AND OTHER HANDLING OF THE PRODUCT No special requirements. 7 PARALLEL PRODUCT AUTHORISATION HOLDER PCO Manufacturing Ltd. Unit 10, Ashbourne Business Park Rath Ashbourne Co. Meath Ireland 8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA0465/226/005 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 12th April 2013 10 DATE OF REVISION OF THE TEXT March 2019 CRN008WLC Leia o documento completo