Aripiprazole DOC 1 mg/ml oral solution

Krajina: Malta

Jazyk: angličtina

Zdroj: Medicines Authority

Aktívna zložka:

ARIPIPRAZOLE

Dostupné z:

Doc Generici srl Via Turati, 40-20121, Milano, Italy

ATC kód:

N05AX12

INN (Medzinárodný Name):

ARIPIPRAZOLE 1 mg/ml

Forma lieku:

ORAL SOLUTION

Zloženie:

ARIPIPRAZOLE 1 mg/ml

Typ predpisu:

POM

Terapeutické oblasti:

PSYCHOLEPTICS

Prehľad produktov:

Licence number in the source country: NOT APPLICAPABLE

Stav Autorizácia:

Authorised

Dátum Autorizácia:

2021-03-04

Príbalový leták

Page 1 of 8
PACKAGE LEAFLET: INFORMATION FOR THE USER
ARIPIPRAZOLE DOC 1 MG/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 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 DOC is and what it is used for.
2.
What you need to know before you take Aripiprazole DOC.
3.
How to take Aripiprazole DOC
4.
Possible side effects.
5.
How to store Aripiprazole DOC.
6.
Contents of the pack and other information.
1.
WHAT ARIPIPRAZOLE DOC IS AND WHAT IT IS USED FOR
Aripiprazole DOC 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 DOC 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 DOC.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ARIPIPRAZOLE DOC
DO NOT TAKE ARIPIPRAZOLE DOC:
•
if you are allergic to aripiprazole or any of the other ingredients of
this medi

Súhrn charakteristických

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Aripiprazole DOC 1 mg/ml oral solution
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 1 mg of aripiprazole.
Excipients with known effect (per mL)
Each ml contains 600 mg of propylene glycol
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Oral solution.
Clear, colourless to light yellow liquid solution with orange flavour.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Aripiprazole DOC solution is indicated for the treatment of
schizophrenia in adults and in
adolescents aged 15 years and older.
Aripiprazole DOC 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 DOC 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 DOC is 10 mg/day or
15
mg/day
(i.e.
10
mL
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 DOC is
effective in a dose range of 10 mg/day to 30 mg/day (i.e. 10 mL 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 DOC
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 not exceed 30 mg.
_Recurrence prevention of manic episode