Aprizexen 10 mg orodispergeerbare tabletten

Država: Nizozemska

Jezik: nizozemščina

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

Aktivna sestavina:

ARIPIPRAZOL

Dostopno od:

PharmaSwiss Ceská republika s.r.o.

Koda artikla:

N05AX12

INN (mednarodno ime):

ARIPIPRAZOLE

Farmacevtska oblika:

Orodispergeerbare tablet

Sestava:

ARABISCHE GOM (E 414) ; ASPARTAAM (E 951) ; BENZYLALCOHOL (E 1519) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; IJZEROXIDE ROOD (E 172) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MALTODEXTRINE ; PROPYLEENGLYCOL (E 1520) ; SILICIUMDIOXIDE (E 551) ; VANILLESMAAKSTOF,

Pot uporabe:

Oraal gebruik

Terapevtsko območje:

Aripiprazole

Povzetek izdelek:

Hulpstoffen: ARABISCHE GOM (E 414); ASPARTAAM (E 951); BENZYLALCOHOL (E 1519); CELLULOSE, MICROKRISTALLIJN (E 460); CROSCARMELLOSE NATRIUM (E 468); IJZEROXIDE ROOD (E 172); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); MALTODEXTRINE; PROPYLEENGLYCOL (E 1520); SILICIUMDIOXIDE (E 551); VANILLESMAAKSTOF;

Datum dovoljenje:

2015-09-02

Navodilo za uporabo

PACKAGE LEAFLET: INFORMATION FOR THE USER
APRIZEXEN 10 MG ORODISPERGEERBARE TABLETTEN
APRIZEXEN 15 MG ORODISPERGEERBARE TABLETTEN
APRIZEXEN 30 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 Aprizexen is and what it is used for
2.
What you need to know before you take Aprizexen
3.
How to take Aprizexen
4.
Possible side effects
5
How to store Aprizexen
6.
Contents of the pack and other information
1.
WHAT APRIZEXEN IS AND WHAT IT IS USED FOR
Aprizexen 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.
Aprizexen 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 Aprizexen.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE APRIZEXEN
DO NOT TAKE APRIZEXEN
-
if you are allergic to aripiprazole or any of the other ingredients of
this medicine (l

Lastnosti izdelka

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Aprizexen 10 mg orodispergeerbare tabletten
Aprizexen 15 mg orodispergeerbare tabletten
Aprizexen 30 mg orodispergeerbare tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Aprizexen 10 mg: Each orodispersible tablet contains 10 mg of
aripiprazole.
Aprizexen 15 mg: Each orodispersible tablet contains 15 mg of
aripiprazole.
Aprizexen 30 mg: Each orodispersible tablet contains 30 mg of
aripiprazole.
Excipients with known effect:
Each 10 mg orodispersible tablet contains 90.30 mg lactose (as
monohydrate) and 1.00 mg aspartame (E951).
Each 15 mg orodispersible tablet contains 135.46 mg lactose (as
monohydrate) and 1.50 mg aspartame (E951).
Each 30 mg orodispersible tablet contains 270.90 mg lactose (as
monohydrate) and 3.00 mg aspartame (E951).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Orodispersible tablet
Aprizexen 10 mg: Round, flat, pink tablets, engraved with ‘10’ on
one side and plain on the other with a
diameter of 8.0 mm ± 0.1 mm.
Aprizexen 15 mg: Round, flat, yellow tablets, engraved with ‘15’
on one side and plain on the other with a
diameter of 9.0 mm ± 0.1 mm.
Aprizexen 30 mg: Round, flat, pink tablets, engraved with ‘30’ on
one side and plain on the other with a
diameter of 10.0 mm ± 0.1 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Aprizexen is indicated for the treatment of schizophrenia in adults
and in adolescents aged 15 years and older.
Aprizexen 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).
Aprizexen 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