Aripiprazole 1mg/ml Oral Solution

País: Malta

Idioma: inglés

Fuente: Medicines Authority

Ingredientes activos:

ARIPIPRAZOLE

Disponible desde:

Brillpharma (Ireland) Limited Inniscarra, Main Street, Rathcoole, Co. Dublin, Ireland

Código ATC:

N05AX12

Designación común internacional (DCI):

ARIPIPRAZOLE 1 mg/ml

formulario farmacéutico:

ORAL SOLUTION

Composición:

ARIPIPRAZOLE 1 mg/ml

tipo de receta:

POM

Área terapéutica:

PSYCHOLEPTICS

Estado de Autorización:

Authorised

Fecha de autorización:

2016-11-15

Información para el usuario

Page 1 of 8 PACKAGE LEAFLET: INFORMATION FOR THE USER
Aripiprazole 1mg/ml
Oral Solution
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 onto
others. It may harm them,
even if their symptoms 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.
Aripiprazole Oral Solution 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.
•
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 YOU TAKE ARIPIPRAZOLE ORAL SOLUTION: DO NOT TAKE ARIPIPRAZOLE ORAL SOLUTION:
•
if you a

Ficha técnica

Page
1
of
22
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Aripiprazole 1mg/ml Oral Solution
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains 1 mg of Aripiprazole.
Excipients with known effect (ml):
200 mg fructose
400 mg sucrose
1.8 mg of methyl parahydroxybenzoate (E218)
0.2 mg of propyl parahydroxybenzoate (E216)
1.0 mg of orange flavour
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Oral solution
Clear, colourless to light yellow liquid.
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 Oral Solution is 10 or
15 ml
solution/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.
A
calibrated
30ml
measuring cup (graduated at every 2.5ml equivalent to 2.5mg) and a 2
ml graduated oral
syringe (graduated at every 0.5 ml equivalent to 0.5mg) and an adaptor
for the syringe are
included in the carton.
Page
2
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22
Aripiprazole Oral Solution 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 fo