Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
ARIPIPRAZOLE
EGIS Pharmaceuticals PLC
N05AX12
ARIPIPRAZOLE
30 Milligram
Orodispersible Tablet
Product subject to prescription which may not be renewed (A)
aripiprazole
Not Marketed
2016-02-26
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Alcartis 30 mg orodispersible tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each orodispersible tablet contains 30 mg aripiprazole. Excipient with known effect Each orodispersible tablet contains 30 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 567 on one side and no code on the other side. The diameter of the tablet is 12 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 Di Baca dokumen lengkap