国家: 塞浦路斯
语言: 希腊文
来源: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας
VALSARTAN; HYDROCHLOROTHIAZIDE
DELORBIS PHARMACEUTICALS LTD (0000009620) 17 ATHINON STREET, ERGATES INDUSTRIAL AREA, LEFKOSIA, 2081, 28629
C09DA03
VALSARTAN AND DIURETICS
320/12.5MG
FILM COATED TABLETS
VALSARTAN (8000001531) 320MG; HYDROCHLOROTHIAZIDE (0000058935) 12,5MG
ORAL USE
Εθνική Διαδικασία
VALSARTAN AND DIURETICS
Νομικό καθεστώς: Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 28 TABS IN BLISTER(S) (310021704) 28 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται
COMPARATIVE TABLE ENGLISH VS GREEK PIL PACKAGE LEAFLET: INFORMATION FOR THE USER COTROVAL 80 MG/12,5 MG FILM-COATED TABLETS COTROVAL 160 MG/12,5 MG FILM-COATED TABLETS COTROVAL 160 MG/25 MG FILM-COATED TABLETS COTROVAL 320 MG/12,5 MG FILM-COATED TABLETS COTROVAL 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 CoTroval is and what it is used for 2. What you need to know before you take CoTroval 3. How to take CoTroval 4. Possible side effects 5. How to store CoTroval 6. Contents of the pack and other information 1. WHAT COTROVAL IS AND WHAT IT IS USED FOR ΦΎΛΛΟ ΟΔΗΓΙΏΝ ΧΡΉΣΗΣ: ΠΛΗΡΟΦΟΡΊΕΣ ΓΙΑ ΤΟΝ ΧΡΉΣΤΗ COTROVAL 80 MG/12,5 MG ΕΠΙΚΑΛΥΜΜΈΝΑ ΜΕ ΛΕΠΤΌ ΥΜΈΝΙΟ ΔΙΣΚΊΑ COTROVAL 160 MG/12,5 MG ΕΠΙΚΑΛΥΜΜΈΝΑ ΜΕ ΛΕΠΤΌ ΥΜΈΝΙΟ ΔΙΣΚΊΑ COTROVAL 160 MG/25 MG ΕΠΙΚΑΛΥΜΜΈΝΑ ΜΕ ΛΕΠΤΌ ΥΜΈΝΙΟ ΔΙΣΚΊΑ COTROVAL 320 MG/12,5 MG ΕΠΙΚΑΛΥΜΜΈΝΑ ΜΕ ΛΕΠΤΌ ΥΜΈΝΙΟ ΔΙΣΚΊΑ COTROVAL 320 MG/25 MG ΕΠΙΚΑΛΥΜΜΈΝΑ ΜΕ ΛΕΠΤΌ ΥΜΈΝΙΟ ΔΙΣΚΊΑ Βαλσαρτάνη / υδροχλωροθειαζίδη ΔΙΑΒΆΣΤΕ ΠΡΟΣΕΚΤΙΚΆ ΟΛΌΚΛΗΡΟ ΤΟ ΦΎΛΛΟ ΟΔΗΓΙΏΝ ΧΡΉΣΗΣ ΠΡΙΝ ΑΡΧΊΣΕΤΕ ΝΑ ΠΑΊΡΝΕΤΕ ΑΥΤΌ ΤΟ ΦΆΡΜΑΚΟ, ΔΙΌΤΙ ΠΕΡΙΛΑΜΒΆΝΕΙ ΣΗΜΑΝΤΙΚΈΣ ΠΛΗΡΟΦΟΡΊΕΣ ΓΙΑ ΣΑΣ. Φυλάξ 阅读完整的文件
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT CoTroval 80 mg/12,5 mg Film-coated tablets CoTroval 160 mg/12,5 mg Film-coated tablets CoTroval 160 mg/25 mg Film-coated tablets CoTroval 320 mg/12,5 mg Film-coated tablets CoTroval 320 mg/25 mg Film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 80 mg valsartan and 12,5 mg hydrochlorothiazide. Each film-coated tablet contains 160 mg valsartan and 12,5 mg hydrochlorothiazide. Each film-coated tablet contains 160 mg valsartan and 25 mg hydrochlorothiazide. Each film-coated tablet contains 320 mg valsartan and 12,5 mg hydrochlorothiazide. Each film-coated tablet contains 320 mg valsartan and 25 mg hydrochlorothiazide. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablets 80 mg/12,5 mg: Pink, biconvex, oval shaped film-coated tablets. 160 mg/12,5 mg: Dark red, biconvex, oval shaped film-coated tablets. 160 mg/25 mg: Yellow, biconvex and oval shaped film-coated tablets with a break line on one side. 320 mg/12,5 mg: Pink, biconvex and oval shaped film-coated tablets. 320 mg/25 mg: Yellow, biconvex and oval shaped film-coated tablets with a break line on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of essential hypertension in adults. CoTroval fixed-dose combination is indicated in patients whose blood pressure is not adequately controlled on valsartan or hydrochlorothiazide monotherapy (see sections 4.3, 4.4, 4.5 and 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION 1 _Posology_ The recommended dose of CoTroval 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 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 controlled on valsa 阅读完整的文件