ABILIFY 5 mg tablets
ABILIFY 10 mg tablets
ABILIFY 15 mg tablets
ABILIFY 30 mg tablets
ABILIFY 10 mg orodispersible tablets
ABILIFY 15 mg orodispersible tablets
ABILIFY 1 mg/ml oral solution
Tablets
5 mg: Each tablet contains 5 mg of aripiprazole.
Excipient with known effect: 67 mg lactose per tablet
10 mg: Each tablet contains 10 mg of aripiprazole.
Excipient with known effect: 62.18 mg lactose per tablet
15 mg: Each tablet contains 15 mg of aripiprazole.
Excipient with known effect: 57 mg lactose per tablet
30 mg: Each tablet contains 30 mg of aripiprazole.
Excipient with known effect: 186.54 mg lactose per tablet
Orodispersible tablets
10 mg orodispersible tablets: Each orodispersible tablet contains 10 mg of aripiprazole.
Excipient with known effect: 2 mg aspartame (E951) and 0.075 mg lactose per orodispersible tablet
15 mg orodispersible tablets: Each orodispersible tablet contains 15 mg of aripiprazole.
Excipient with known effect: 3 mg aspartame (E951) and 0.1125 mg lactose per orodispersible tablet
Oral solution
Each ml contains 1 mg of aripiprazole.
Excipients with known effect:
200 mg fructose per ml
400 mg sucrose per ml
1.8 mg methyl parahydroxybenzoate (E218) per ml
0.2 mg propyl parahydroxybenzoate (E216) per ml
For the full list of excipients, see section 6.1.
Tablet
5 mg: Rectangular and blue, engraved with "A-007" and "5" on one side.
10 mg: Rectangular and pink, engraved with "A-008" and "10" on one side.
15 mg: Round and yellow, engraved with "A-009" and "15" on one side.
30 mg: Round and pink, engraved with "A-011" and "30" on one side.
Orodispersible tablet
10 mg: Round and pink, marked with "A" over "640" on one side and "10" on the other.
15 mg: Round and yellow, marked with "A" over "641" on one side and "15" on the other.
Oral solution
Clear, colourless to light yellow liquid.
ABILIFY is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older.
ABILIFY 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).
ABILIFY 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).
Posology
Adults
Schizophrenia: the recommended starting dose for ABILIFY is 10 or 15 mg/day (Oral solution: i.e. 10 or 15 ml solution/day) with a maintenance dose of 15 mg/day administered on a once-a-day schedule without regard to meals. Oral solution: A calibrated measuring cup and a 2 ml calibrated dropper are included in the carton.
ABILIFY is effective in a dose range of 10 to 30 mg/day (Oral solution: i.e. 10 to 30 ml solution/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 ABILIFY is 15 mg (Oral solution i.e. 15 ml solution/day) 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 (Oral solution i.e. 30 ml solution/day).
Recurrence prevention of manic episodes in Bipolar I Disorder: for preventing recurrence of manic episodes in patients who have been receiving aripiprazole as monotherapy or combination therapy, continue therapy at the same dose. Adjustments of daily dosage, including dose reduction should be considered on the basis of clinical status.
Paediatric population
Schizophrenia in adolescents aged 15 years and older: the recommended dose for ABILIFY is 10 mg/day administered on a once-a-day schedule without regard to meals. Treatment should be initiated at 2 mg (using ABILIFY oral solution 1 mg/ml) for 2 days, titrated to 5 mg for 2 additional days to reach the recommended daily dose of 10 mg. When appropriate, subsequent dose increases should be administered in 5 mg increments without exceeding the maximum daily dose of 30 mg (see section 5.1).
ABILIFY is effective in a dose range of 10 to 30 mg/day. Enhanced efficacy at doses higher than a daily dose of 10 mg has not been demonstrated although individual patients may benefit from a higher dose.
ABILIFY is not recommended for use in patients with schizophrenia below 15 years of age due to insufficient data on safety and efficacy (see sections 4.8 and 5.1).
Manic episodes in Bipolar I Disorder in adolescents aged 13 years and older: the recommended dose for ABILIFY is 10 mg/day administered on a once-a-day schedule without regard to meals. Treatment should be initiated at 2 mg (using ABILIFY oral solution 1 mg/ml) for 2 days, titrated to 5 mg for 2 additional days to reach the recommended daily dose of 10 mg.
The treatment duration should be the minimum necessary for symptom control and must not exceed 12 weeks. Enhanced efficacy at doses higher than a daily dose of 10 mg has not been demonstrated, and a daily dose of 30 mg is associated with a substantially higher incidence of significant undesirable effects including EPS related events, somnolence, fatigue and weight gain (see section 4.8). Doses higher than 10 mg/day should therefore only be used in exceptional cases and with close clinical monitoring (see sections 4.4, 4.8 and 5.1).
Younger patients are at increased risk of experiencing adverse ev
