Aribit ODT 15 mg orodispergeerbare tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

ARIPIPRAZOL 15 mg/stuk

Beschikbaar vanaf:

Zaklady Farmaceutyczne Polpharma SA Synthesis Section PS III, Pelplinska 19 83-200 STAROGARD GDANSKI (POLEN)

ATC-code:

N05AX12

INN (Algemene Internationale Benaming):

ARIPIPRAZOL 15 mg/stuk

farmaceutische vorm:

Orodispergeerbare tablet

Samenstelling:

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

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Aripiprazole

Product samenvatting:

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

Autorisatie datum:

2015-09-02

Bijsluiter

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

Productkenmerken

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Aribit ODT 10 mg orodispergeerbare tabletten
Aribit ODT 15 mg orodispergeerbare tabletten
Aribit ODT 30 mg orodispergeerbare tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Aribit ODT 10 mg: Each orodispersible tablet contains 10 mg of
aripiprazole.
Aribit ODT 15 mg: Each orodispersible tablet contains 15 mg of
aripiprazole.
Aribit ODT 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), 1.00 mg aspartame
(E951), 0.0036 mg benzyl alcohol and 0.86 mg (0,037 mmol) sodium.
Each 15 mg orodispersible tablet contains 135.46 mg lactose (as
monohydrate), 1.50 mg aspartame
(E951), 0.0054 mg benzyl alcohol and 1.29 mg (0,056 mmol) sodium.
Each 30 mg orodispersible tablet contains 270.90 mg lactose (as
monohydrate), 3.00 mg aspartame
(E951), 0.0108 mg benzyl alcohol and 2.58 mg (0,112 mmol) sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Orodispersible tablet
Aribit ODT 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.
Aribit ODT 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.
Aribit ODT 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
Aribit ODT is indicated for the treatment of schizophrenia in adults
and in adolescents aged 15 years
and older.
Aribit ODT 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).
Aribit ODT is indicated for the treatment up to 12 weeks of moderate
to severe manic epi