TROVAL 40MG FILM COATED TABLETS

Land: Kypros

Språk: gresk

Kilde: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

Aktiv ingrediens:

VALSARTAN

Tilgjengelig fra:

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

ATC-kode:

C09CA03

INN (International Name):

VALSARTAN

Dosering :

40MG

Legemiddelform:

FILM COATED TABLETS

Sammensetning:

VALSARTAN (8000001531) 40MG

Administreringsrute:

ORAL USE

Resept typen:

Εθνική Διαδικασία

Terapeutisk område:

VALSARTAN

Produkt oppsummering:

Νομικό καθεστώς: Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 28 TABS IN BLISTER(S) (PVC/PE/PVDC/ALU) () 28 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 28 TABS IN BLISTER(S) (OPA/ALU/PVC-ALU) () 28 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται

Informasjon til brukeren

COMPARATIVE TABLE OF PIL-EN VS PIL-GR
Package Leaflet: Information for the user
Troval 40 mg Film-coated tablets
Troval 80 mg Film-coated tablets
Troval 160 mg Film-coated tablets
Valsartan
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 Troval is and what it is used for
2. What you need to know before you take Troval
3. How to take Troval
4. Possible side effects
5. How to store Troval
6. Contents of the pack and other information
1.
What Troval is and what it is used for
Φύλλο οδηγιών χρήσης: Πληροφορίες για
το χρήστη
Troval 40 mg Επικαλυμμένα με λεπτό υμένιο
δισκία
Troval 80 mg Επικαλυμμένα με λεπτό υμένιο
δισκία
Troval 160 mg Επικαλυμμένα με λεπτό υμένιο
δισκία
Βαλσαρτάνη
Διαβάστε προσεκτικά ολόκληρο το φύλλο
οδηγιών χρήσης προτού
αρχίσετε να παίρνετε αυτό το φάρμακο,
διότι περιλαμβάνει
σημαντικές πληροφορίες για σας.

Φυλάξτε αυτό το φύλλο οδηγιών χρήσης.
Ίσως χρειαστεί να το
διαβάσετε ξανά.

Εάν
έχετε
περαιτέρω
απορίες,
ρωτήστε
το
γιατρό
ή
το
φαρμακοποιό σας.

Η συνταγή για αυτό το φάρμακο
χορηγήθηκε αποκλειστικά για
σας. Δεν πρέπει

Preparatomtale

1.
NAME OF THE MEDICINAL PRODUCT
Troval 40 mg Film-coated tablets
Troval 80 mg Film-coated tablets
Troval 160 mg Film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 40 mg valsartan.
One film-coated tablet contains 80 mg valsartan.
One film-coated tablet contains 160 mg valsartan.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
40 mg:
Yellow, ovaloid, slightly convex film-coated tablets with bevelled
edges, scored on one side.
80 mg:
Slightly red, round, slightly convex film-coated tablets with bevelled
edges, scored on one side.
160 mg:
Grey-orange, ovaloid, slightly convex film-coated tablets with
bevelled edges, scored on one side.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hypertension (only 80 mg and 160 mg)
Treatment of essential hypertension.
Recent myocardial infarction
Treatment of clinically stable patients with symptomatic heart failure
or asymptomatic left ventricular
systolic dysfunction after a recent (12 hours-10 days) myocardial
infarction (see sections 4.4 and 5.1).
Heart failure
Treatment of adult patients with symptomatic heart failure when
ACE-inhibitors are not tolerated or
in beta-blocker intolerant patients as add-on therapy to
ACE-inhibitors when mineralocorticoid
receptor antagonists cannot be used (see sections 4.2, 4.4, 4.5 and
5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
1
SUMMARY OF PRODUCT
Posology
Hypertension (only 80 mg and 160 mg)
The recommended starting dose of Troval is 80 mg once daily. The
antihypertensive effect is
substantially present within 2 weeks, and maximal effects are attained
within 4 weeks. In some
patients whose blood pressure is not adequately controlled, the dose
can be increased to 160 mg and
to a maximum of 320 mg.
Troval may also be administered with other antihypertensive agents.
The addition of a diuretic such
as hydrochlorothiazide will decrease blood pressure even further in
these patients (see sections 4.3,
4.4, 4.5 and 5.1).
Recent myocardial infarction
In