CAPOLEV 16MG TABLETS

Land: Cypern

Sprog: græsk

Kilde: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

Indlægsseddel Indlægsseddel (PIL)
01-01-2019
Produktets egenskaber Produktets egenskaber (SPC)
15-03-2018

Aktiv bestanddel:

CANDESARTAN CILEXETIL

Tilgængelig fra:

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

ATC-kode:

C09CA06

INN (International Name):

CANDESARTAN

Dosering:

16MG

Lægemiddelform:

TABLETS

Sammensætning:

CANDESARTAN CILEXETIL (8000001579) 16MG

Indgivelsesvej:

ORAL USE

Recept type:

Εθνική Διαδικασία

Terapeutisk område:

CANDESARTAN

Produkt oversigt:

Νομικό καθεστώς: Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 28 TABS IN BLISTER(S) (310008405) 28 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται

Indlægsseddel

                                COMPARATIVE TABLE OF PIL-EN VS PIL-GR
PACKAGE LEAFLET: INFORMATION FOR THE USER
CAPOLEV 4 MG TABLETS
CAPOLEV 8 MG TABLETS
CAPOLEV 16 MG TABLETS
CAPOLEV 32 MG TABLETS
candesartan cilexetil
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 Capolev is and what it is used for
2. What you need to know before you take Capolev
3. How to take Capolev
4. Possible side effects
5. How to store Capolev
6. Contents of the pack and other information
1. WHAT CAPOLEV IS AND WHAT IT IS USED FOR
ΦΎΛΛΟ ΟΔΗΓΙΏΝ ΧΡΉΣΗΣ: ΠΛΗΡΟΦΟΡΊΕΣ ΓΙΑ
ΤΟΝ ΧΡΉΣΤΗ
CAPOLEV 4 MG ΔΙΣΚΊΑ
CAPOLEV 8 MG ΔΙΣΚΊΑ
CAPOLEV 16 MG ΔΙΣΚΊΑ
CAPOLEV 32 MG ΔΙΣΚΊΑ
καντεσαρτάνη_ _σιλεξετίλη
ΔΙΑΒΆΣΤΕ ΠΡΟΣΕΚΤΙΚΆ ΟΛΌΚΛΗΡΟ ΤΟ ΦΎΛΛΟ
ΟΔΗΓΙΏΝ ΧΡΉΣΗΣ ΠΡΙΝ
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. ∆εν πρέπει να δώσετε το φάρµακο
σε άλλους. Μπορεί να
τους προκαλέσει 
                                
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Produktets egenskaber

                                SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Cardax 4 mg Tablets
Cardax 8 mg Tablets
Cardax 16 mg Tablets
Cardax 32 mg Tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
For 4mg strength: Each tablet contains 4 mg candesartan cilexetil.
For 8 mg strength: Each tablet contains 8 mg candesartan cilexetil.
For 16 mg strength: Each tablet contains 16 mg candesartan cilexetil.
For 32 mg strength: Each tablet contains 32 mg candesartan cilexetil.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablets
For 4 mg strength - White to off-white, round tablets with a
break-line on one side.
For 8 mg strength - Pink, round tablets with a break line on one side.
For 16 mg strength – Dark pink, round tablets with a break line on
one side.
For 32 mg strength – Dark pink, round tablets with a break line on
one side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Cardax is indicated for the:

Treatment of essential hypertension in adults.

Treatment of adult patients with heart failure and impaired left
ventricular systolic
function (left ventricular ejection fraction ≤ 40%) when
ACE-inhibitors are not tolerated
or as add-on therapy to ACE-inhibitors in patients with symptomatic
heart failure, despite
optimal therapy, when mineralocorticoid receptor antagonists are not
tolerated (see
sections 4.2, 4.4, 4.5 and 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Posology in Hypertension_
1
The recommended initial dose and usual maintenance dose of Cardax is 8
mg once daily. Most of
the antihypertensive effect is attained within 4 weeks. In some
patients whose blood pressure is not
adequately controlled, the dose can be increased to 16 mg once daily
and to a maximum of 32 mg
once daily. Therapy should be adjusted according to blood pressure
response.
Cardax may also be administered with other antihypertensive agents
(see sections 4.3, 4.4, 4.5 and
5.1). Addition of hydrochlorothiazide has been shown to have an
additive antihypertensive effect
with various doses of Cardax.

                                
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Produktets egenskaber Produktets egenskaber engelsk 17-01-2019

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