Aripiprazole Oral Solution 1mg/ml

Kraj: Malta

Język: angielski

Źródło: Medicines Authority

Składnik aktywny:

ARIPIPRAZOLE

Dostępny od:

LIQMEDS Limited

Kod ATC:

N05AX12

INN (International Nazwa):

ARIPIPRAZOLE

Forma farmaceutyczna:

ORAL DROPS, SOLUTION

Skład:

ARIPIPRAZOLE 1 milligram(s)

Typ recepty:

POM

Dziedzina terapeutyczna:

PSYCHOLEPTICS

Status autoryzacji:

Authorised

Data autoryzacji:

2016-11-15

Ulotka dla pacjenta

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 are allergic

Charakterystyka produktu

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.
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
for
Aripipraz