Aripiprazol Doc Generici 15 mg, orodispergeerbare tabletten

Država: Nizozemska

Jezik: nizozemščina

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

Aktivna sestavina:

ARIPIPRAZOL

Dostopno od:

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

Koda artikla:

N05AX12

INN (mednarodno ime):

ARIPIPRAZOLE

Farmacevtska oblika:

Orodispergeerbare tablet

Sestava:

ACESULFAAM KALIUM (E 950) ; ASPARTAAM (E 951) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; CROSPOVIDON (E 1202) ; IJZEROXIDE GEEL (E 172) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; SILICIUMDIOXIDE (E 551) ; VANILLINE ; WIJNSTEENZUUR (D-,L-),

Pot uporabe:

Oraal gebruik

Terapevtsko območje:

Aripiprazole

Povzetek izdelek:

Hulpstoffen: ACESULFAAM KALIUM (E 950); ASPARTAAM (E 951); CELLULOSE, MICROKRISTALLIJN (E 460); CROSCARMELLOSE NATRIUM (E 468); CROSPOVIDON (E 1202); IJZEROXIDE GEEL (E 172); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); SILICIUMDIOXIDE (E 551); VANILLINE; WIJNSTEENZUUR (D-,L-);

Datum dovoljenje:

2015-07-21

Navodilo za uporabo

_02/2016 – NL MA approval; 03/2016 –NL approval var. 02 –
12/2016 – Nl approval var. 05; 06/2019 – NL approval var. 08;
12/2019 – _
_NL approval var. 07 – proposed var. 010 _
PACKAGE LEAFLET: INFORMATION FOR THE USER
ARIPIPRAZOL DOC GENERICI 10 MG, ORODISPERGEERBARE TABLETTEN
ARIPIPRAZOL DOC GENERICI 15 MG, ORODISPERGEERBARE 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 it is 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
amounts of energy, needing much less sleep
than usual, talking very quickly with racing ideas and sometimes
severe irritab

Lastnosti izdelka

_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; proposed var. 010 _
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 Disorder in adolescents aged 13 years and older (see section
5.1)