COTROVAL 80/12.5MG FILM COATED TABLETS

Country: Кипар

Језик: Грчки

Извор: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

Активни састојак:

VALSARTAN; HYDROCHLOROTHIAZIDE

Доступно од:

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

АТЦ код:

C09DA03

INN (Међународно име):

VALSARTAN AND DIURETICS

Дозирање:

80/12.5MG

Фармацеутски облик:

FILM COATED TABLETS

Састав:

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

Пут администрације:

ORAL USE

Тип рецептора:

Εθνική Διαδικασία

Терапеутска област:

VALSARTAN AND DIURETICS

Резиме производа:

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

Информативни летак

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�

Карактеристике производа

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