COTROVAL 80/12.5MG FILM COATED TABLETS

Χώρα: Κύπρος

Γλώσσα: Ελληνικά

Πηγή: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

Δραστική ουσία:

VALSARTAN; HYDROCHLOROTHIAZIDE

Διαθέσιμο από:

DELORBIS PHARMACEUTICALS LTD (0000009620) 17 ATHINON STREET, ERGATES INDUSTRIAL AREA, LEFKOSIA, 2081, 28629

Φαρμακολογική κατηγορία (ATC):

C09DA03

INN (Διεθνής Όνομα):

VALSARTAN AND DIURETICS

Δοσολογία:

80/12.5MG

Φαρμακοτεχνική μορφή:

FILM COATED TABLETS

Σύνθεση:

VALSARTAN (8000001531) 80MG; HYDROCHLOROTHIAZIDE (0000058935) 12,5MG

Οδός χορήγησης:

ORAL USE

Τρόπος διάθεσης:

Εθνική Διαδικασία

Θεραπευτική περιοχή:

VALSARTAN AND DIURETICS

Περίληψη προϊόντος:

Νομικό καθεστώς: Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 28 TABS IN BLISTER(S) (310021404) 28 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται

Φύλλο οδηγιών χρήσης

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�

Αρχείο Π.Χ.Π.

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