ELXEDA 15MG TABLETS

Nazione: Cipro

Lingua: greco

Fonte: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

Principio attivo:

ARIPIPRAZOLE

Commercializzato da:

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

Codice ATC:

N05AX12

INN (Nome Internazionale):

ARIPIPRAZOLE

Dosaggio:

15MG

Forma farmaceutica:

TABLETS

Composizione:

ARIPIPRAZOLE (8000002594) 15MG

Via di somministrazione:

ORAL USE

Tipo di ricetta:

Εθνική Διαδικασία

Area terapeutica:

ARIPIPRAZOLE

Dettagli prodotto:

Νομικό καθεστώς: Με Ιατρική Συνταγή; PACK WITH 28 TABS IN BLISTER(S) () 28 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή; PACK WITH 56 TABS IN BLISTER(S) () 56 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή

Foglio illustrativo

COMPARATIVE TABLE ENGLISH VS GREEK PIL
Package leaflet: Information for the user
Elxeda 10 mg tablets
Elxeda 15 mg tablets
Elxeda 30 mg tablets
aripiprazole
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 Elxeda is and what it is used for
2. What you need to know before you take Elxeda
3. How to take Elxeda
4. Possible side effects
5. How to store Elxeda
6. Contents of the pack and other information
Φύλλο οδηγιών χρήσης: Πληροφορίες για
τον χρήστη
Elxeda 10 mg δισκία
Elxeda 15 mg δισκία
Elxeda 30 mg δισκία
αριπιπραζόλη
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
τον γιατρό σας ή τον
φαρμακοποιό σας.

Η συνταγή για αυτό το φάρμακο
χορηγήθηκε αποκλειστικά για σας. Δεν
πρέπει να δώσετε το φάρμακο σε άλλους.
Μπορεί να τους προκαλέσει
βλάβη, ακόμα και όταν τα συμπτώματα
της ασθενείας τους είναι ίδια

Scheda tecnica

1.
NAME OF THE MEDICINAL PRODUCT
Elxeda 10 mg Tablets
Elxeda 15 mg Tablets
Elxeda 30 mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Elxeda 10 mg tablet: each tablet contains 10 mg of aripiprazole.
Excipient(s) with known effect: each tablet contains 62.33 mg of
lactose monohydrate per tablet.
Elxeda 15 mg tablet: each tablet contains 15 mg of aripiprazole.
Excipient(s) with known effect: each tablet contains 93.42 mg of
lactose monohydrate per tablet.
Elxeda 30 mg tablet: each tablet contains 30 mg of aripiprazole.
Excipient(s) with known effect: each tablet contains 186.99 mg of
lactose monohydrate per tablet.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Elxeda 10 mg tablets are pink, modified rectangular tablets of
approximately 8.5 x 4.0 mm, with a
break line on one side.
Elxeda 15 mg tablets are light yellow, round tablets of approximately
7.0 mm in diameter.
Elxeda 30 mg tablets are pink, round tablets of approximately 9.5 mm
in diameter, with a break
line on one side.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Elxeda is indicated for the treatment of schizophrenia in adults and
in adolescents aged 15 years
and older.
Elxeda is indicated for the treatment of moderate to severe manic
episodes in Bipolar I Disorder
and for the prevention of a new manic episode in adults who
experienced predominantly manic
episodes and whose manic episodes responded to aripiprazole treatment
(see section 5.1).
1
SUMMARY OF PRODUCT CHARACTERISTICS
Elxeda is indicated for the treatment up to 12 weeks of moderate to
severe manic episodes in
Bipolar I Disorder in adolescents aged 13 years and older (see section
5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults _
_Schizophrenia:_ the recommended starting dose for Elxeda is 10 or 15
mg/day with a maintenance
dose of 15 mg/day administered on a once-a-day schedule without regard
to meals.
Aripiprazole is effective in a dose range of 10 to 30 mg/day. Enhanced
efficacy at doses higher
than a daily dose of 15 mg has not