Nazione: Cipro
Lingua: greco
Fonte: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας
ARIPIPRAZOLE
DELORBIS PHARMACEUTICALS LTD (0000009620) 17 ATHINON STREET, ERGATES INDUSTRIAL AREA, LEFKOSIA, 2081, 28629
N05AX12
ARIPIPRAZOLE
10MG
TABLETS
ARIPIPRAZOLE (8000002594) 10MG
ORAL USE
Εθνική Διαδικασία
ARIPIPRAZOLE
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
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 Leggi il documento completo
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 Leggi il documento completo