Šalis: Airija
kalba: anglų
Šaltinis: HPRA (Health Products Regulatory Authority)
Valsartan; Hydrochlorothiazide
PCO Manufacturing Ltd.
C09DA03
Valsartan; Hydrochlorothiazide
320 mg/25 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
valsartan and diuretics
Authorised
2012-11-30
_ _ _ _ _ _ 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 Perskaitykite visą dokumentą
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/25 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 320 mg valsartan and 25 mg hydrochlorothiazide. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. _Product imported from Italy:_ Yellow, ovaloid shaped, beveled edge, film coated tablet, imprinted (debossed) with “NVR” on one side and “CTI” on the reverse side. 4 CLINICAL PARTICULARS As per PA0896/007/005 5 PHARMACOLOGICAL PROPERTIES As per PA0896/007/005 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) Yellow iron oxide (E172) 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf-life expiry date of this product is the date shown on the blister and outer package of the product on the market in the country of origin. 6.4 SPECIAL PRECAUTIONS FOR STORAGE Store in the original package in order to protect from moisture. Health Products Regulatory Authority 15 March 2019 CRN008WLC Page 2 of 2 Do not store above 30 °C 6.5 NATURE AND CONTENTS OF CONTAINER 28 film-coated tablets contained in blisterpacks in an outer 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 PPA0465/226/004 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 30th November 2012 10 DATE OF REVISION OF THE TEXT March 2019 CRN008WLC Perskaitykite visą dokumentą