ALCARTIS

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

ARIPIPRAZOLE

Tilgjengelig fra:

EGIS Pharmaceuticals PLC

ATC-kode:

N05AX12

INN (International Name):

ARIPIPRAZOLE

Dosering :

10 Milligram

Legemiddelform:

Orodispersible Tablet

Resept typen:

Product subject to prescription which may not be renewed (A)

Terapeutisk område:

aripiprazole

Autorisasjon status:

Not Marketed

Autorisasjon dato:

2016-02-26

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Alcartis 10 mg orodispersible tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each orodispersible tablet contains 10 mg aripiprazole.
Excipient with known effect
Each orodispersible tablet contains 10 mg fructose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Orodispersible tablet
White or almost white, homogeneous or slightly dotted, round, flat,
bevelled edged tablets with stylized E and code 565
on one side and no code on the other side. The diameter of the tablet
is 8 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Alcartis is indicated for the treatment of schizophrenia in adults and
in adolescents aged 15 years and older.
Alcartis 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).
Alcartis 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 Alcartis 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.
Alcartis 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 been demonstrated although individual patients may benefit
from a higher dose. The maximum daily dose
should not exceed 30 mg.
_Manic episodes in Bipolar I Disorder:_ the recommended starting dose
for Alcartis is 15 mg administered on a once-a-
day schedule without regard to meals as monotherapy or combination
therapy (see section 5.1). Some patients may
benefit from a higher dose. The maximum daily dose should not exceed
30 mg.
_Recurrence prevention of manic episodes in Bipolar I Dis