Aprizexen 15 mg, 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:

Tablet

Sestava:

CELLULOSE, MICROKRISTALLIJN (E 460) ; HYPROLOSE (E 463) ; IJZEROXIDE GEEL (E 172) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT (E468),

Pot uporabe:

Oraal gebruik

Terapevtsko območje:

Aripiprazole

Povzetek izdelek:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); HYPROLOSE (E 463); IJZEROXIDE GEEL (E 172); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); NATRIUMZETMEELGLYCOLAAT (E468);

Datum dovoljenje:

2015-09-07

Navodilo za uporabo

Common Technical Document
Aripiprazole
Tablets
M1.3.1_03.ARZ.tab.100.03
Page 1 of 7
1.3.1
Package leaflet - Core
PACKAGE LEAFLET: INFORMATION FOR THE USER
APRIZEXEN 15 MG, TABLETTEN APRIZEXEN 30 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 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.
_ _
Common Technical Document
Aripiprazole
Tablets
M1.3.1_03.ARZ.tab.100.03
Page 2 of 7
2
WHAT YOU NEED TO KNOW BEFORE

Lastnosti izdelka

Common Technical Document
Aripiprazole
Tablets
M1.3.1_01.ARZ.tab.100.03
.core
Page 1 of 22
1.3.1
Summary of Product Characteristics - Core
1.
NAME OF THE MEDICINAL PRODUCT
Aprizexen 15 mg, tabletten
Aprizexen 30 mg, tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Aprizexen 15 mg tablet contains 15 mg of aripiprazole.
Each Aprizexen 30 mg tablet contains 30 mg of aripiprazole.
Excipient with known effect:
_ [15 mg tablets] _
99.8 mg lactose monohydrate per tablet
_ [30 mg tablets] _
199.5 mg lactose monohydrate per tablet
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
_[15 mg tablets] _
Round (approximately 7 mm) and yellow, with possible darker spots,
engraved with “ARZ” and “15”
on one side.
_ [30 mg tablets] _
Round (approximately 9 mm) and pink, with possible darker spots,
engraved with “ARZ” and “30” on
one side.
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).
Common Technical Document
Aripiprazole
Tablets
M1.3.1_01.ARZ.tab.100.03
.core
Page 2 of 22
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults _
Schizophrenia: the recommended starting dose for Aprizexen is 10 or 15
mg/day with a maintenance
dose of 15 mg/day administered on a once-a-day schedule without regard
to meals.
Aprizexen is effective in a dose range of 10 to 30 mg/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