Aripiprazol Doc Generici 5 mg, tabletten

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

ARIPIPRAZOL 5 mg/stuk

Beschikbaar vanaf:

DOC Generici S.r.l. Via Filippo Turati 40 20121 MILANO (ITALIË)

ATC-code:

N05AX12

INN (Algemene Internationale Benaming):

ARIPIPRAZOL 5 mg/stuk

farmaceutische vorm:

Tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; HYPROLOSE (E 463) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT, CELLULOSE, MICROKRISTALLIJN (E 460) ; HYPROLOSE (E 463) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT (E468),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Aripiprazole

Product samenvatting:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); HYPROLOSE (E 463); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); NATRIUMZETMEELGLYCOLAAT (E468);

Autorisatie datum:

1900-01-01

Bijsluiter

_02/2016 – NL MA approval; 03/2016 –NL approval var. 02; 06/2016
– NL approval var. 03; 12/2016 - NL approval var. 05; _
_06/2019 – NL approval var. 08; 11/2019 – renewal; 12/2019 – NL
approval var. 07; 05/2020 – NL approval var. 10; 02/2021: _
_approval var. 11 – Proposed var 14 _
PACKAGE LEAFLET: INFORMATION FOR THE USER
ARIPIPRAZOL DOC GENERICI 5 MG, TABLETTEN
ARIPIPRAZOL DOC GENERICI 10 MG, TABLETTEN
ARIPIPRAZOL DOC GENERICI 15 MG, TABLETTEN
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 Aripiprazol Doc Generici are and what they are used for
2.
What you need to know before you take Aripiprazol Doc Generici
3.
How to take Aripiprazol Doc Generici
4.
Possible side effects
5.
How to store Aripiprazol Doc Generici
6.
Contents of the pack and other information
1
WHAT ARIPIPRAZOL DOC GENERICI IS AND WHAT IT IS USED FOR
ARIPIPRAZOL DOC
GENERICI
CONTAINS
THE ACTIVE
SUBSTANCE
ARIPIPRAZOLE
AND BELONG
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.
Aripiprazol Doc Generici 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
amou

Productkenmerken

_02/2016 – NL MA approval; 03/2016 –NL approval var. 02; 06/2016
– NL approval var. 03; 12/2016 – NL approval var. 05 - _
_06/2019 – NL approval var. 08; 11/2019 – renewal; 12/2019 – NL
approval var. 07; 05/2020 – NL approval var.10; 02/2021: _
_approval var. 11 – Proposed var 14 _
1.
NAME OF THE MEDICINAL PRODUCT
Aripiprazol Doc Generici 5 mg, tabletten
Aripiprazol Doc Generici 10 mg, tabletten
Aripiprazol Doc Generici 15 mg, tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ARIPIPRAZOL DOC Generici 5 mg tabletten contains 5 mg of
aripiprazole
Each ARIPIPRAZOL DOC Generici 10 mg tabletten contains 10 mg of
aripiprazole.
Each ARIPIPRAZOL DOC Generici 15 mg tabletten contains 15 mg of
aripiprazole.
Excipient with known effect:
_[5 mg tablets] _
33.3 mg lactose monohydrate per tablet and sodium
_[10 mg tablets] _
66.5 mg lactose monohydrate per tablet and sodium
_[15 mg tablets] _
99.8 mg lactose monohydrate per tablet and sodium
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
_[5 mg tablets] _
Round (approximately 5 mm) and white, engraved with “ARZ” on one
side and “5” on the other side.
_[10 mg tablets] _
Oblong (approximately 8 mm x 4 mm) and pink, with possible darker
spots, engraved with “ARZ” and “10”
on one side.
_[15 mg tablets] _
Round (approximately 7 mm) and yellow, with possible darker spots,
engraved with “ARZ” and “15” on one
side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ARIPIPRAZOL DOC Generici is indicated for the treatment of
schizophrenia in adults and in adolescents
aged 15 years and older.
ARIPIPRAZOL DOC Generici 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).
ARIPIPRAZOL DOC Generici is indicated for the treatment up to 12 weeks
of moderate to severe manic
episodes in
Bipolar I Di