Aripiprazole 1mg/ml oral solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Aripiprazole

Available from:

Wockhardt UK Limited

ATC code:

N05AX; N05AX12

INN (International Name):

Aripiprazole

Dosage:

1 milligram(s)/millilitre

Pharmaceutical form:

Oral solution

Administration route:

oral use

Units in package:

150 ml

Prescription type:

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

Manufactured by:

CP Pharmaceuticals Ltd

Therapeutic group:

other antipsychotics

Therapeutic area:

Other antipsychotics; aripiprazole

Therapeutic indications:

Aripiprazole is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older. Aripiprazole 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

Authorization status:

Marketed

Authorization date:

2015-09-18

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
ARIPIPRAZOLE 1MG/ML ORAL SOLUTION
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 Aripiprazole Oral Solution_ _is and what it is used for
2. What you need to know before you take Aripiprazole Oral Solution
3. How to take Aripiprazole Oral Solution
4. Possible side effects
5. How to store Aripiprazole Oral Solution
6. Contents of the pack and other information
1.
WHAT ARIPIPRAZOLE ORAL SOLUTION IS AND WHAT IT IS USED FOR
Aripiprazole Oral Solution contains the active substance aripiprazole
and belongs to a group of
medicines called antipsychotics. It is used to treat adults and
adolescents aged 15 years and older
who suffer from a disease characterised by symptoms such as hearing,
seeing or sensing things which
are not there, suspiciousness, mistaken beliefs, incoherent speech and
behaviour and emotional
flatness. People with this condition may also feel depressed, guilty,
anxious or tense.
Aripiprazole Oral Solution is used to treat adults and adolescents
aged 13 years and older who suffer
from a condition with symptoms such as feeling "high", having
excessive amounts of energy,
needing much less sleep than usual, talking very quickly with racing
ideas and sometimes severe
irritability. In adults it also prevents this condition from returning
in patients who have responded to
the treatment with Aripiprazole Oral Solution.
2. WHAT YOU NEED TO KNOW BEFORE TAKING ARIPIPRAZOLE ORAL SOLUTION
DO NOT TAKE ARIPIPRAZOLE ORAL SOLUTION

if you are allerg

Summary of Product characteristics

Health Products Regulatory Authority
02 October 2020
CRN009WWX
Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Aripiprazole 1mg/ml oral solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 1 mg of aripiprazole.
Excipients:
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 a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral solution.
Clear, colourless to light yellow solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Aripiprazole is indicated for the treatment of schizophrenia in adults
and in adolescents aged 15 years and older.
Aripiprazole 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).
Aripiprazole 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 aripiprazole is 10
or 15 mg/day (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. Aripiprazole is effective in a
dose range of 10 to 30 mg/day (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 aripiprazole is 15 mg (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