Aripiprazol Sandoz 30 mg orodispergeerbare tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

ARIPIPRAZOL 30 mg/stuk

Beschikbaar vanaf:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

ATC-code:

N05AX12

INN (Algemene Internationale Benaming):

ARIPIPRAZOL 30 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 ROOD (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 ROOD (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 ROOD (E 172); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); MALTODEXTRINE; PROPYLEENGLYCOL (E 1520); SILICIUMDIOXIDE (E 551); VANILLESMAAKSTOF;

Autorisatie datum:

2015-09-02

Bijsluiter

Sandoz B.V.
Page 1/13
Aripiprazol Sandoz
®
10, 15, 30 mg orodispergeerbare
tabletten
RVG 115588, 115589, 115590
1313-V11B
1.3.1.3 Bijsluiter
Januari 2023
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ARIPIPRAZOL SANDOZ
® 10 MG ORODISPERGEERBARE TABLETTEN
ARIPIPRAZOL SANDOZ
® 15 MG ORODISPERGEERBARE TABLETTEN
ARIPIPRAZOL SANDOZ
® 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 [Nationally completed name] is and what it is used for
2.
What you need to know before you take [Nationally completed name]
3.
How to take [Nationally completed name]
4.
Possible side effects
5
How to store [Nationally completed name]
6.
Contents of the pack and other information
1.
WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR
[Nationally completed name] 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.
[Nationally completed name] 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

Productkenmerken

Sandoz B.V.
Page 1/28
Aripiprazol Sandoz 10, 15, 30 mg orodispergeerbare
tabletten
RVG 115588, 115589, 115590
1311-V10A
1.3.1.1 Samenvatting van de Productkenmerken
Januari 2023
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Aripiprazol Sandoz 10 mg orodispergeerbare tabletten
Aripiprazol Sandoz 15 mg orodispergeerbare tabletten
Aripiprazol Sandoz 30 mg orodispergeerbare tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_10 mg: _
Each orodispersible tablet contains 10 mg of aripiprazole.
Excipients with known effect
Each orodispersible tablet contains 90.30 mg of lactose (as
monohydrate), 1.0 mg of aspartame, and
up to 0.0036 mg of benzyl alcohol.
_15 mg: _
Each orodispersible tablet contains 15 mg of aripiprazole.
Excipients with known effect
Each orodispersible tablet contains 135.46 mg of lactose (as
monohydrate), 1.5 mg of aspartame, and
up to 0.0054 mg of benzyl alcohol.
_30 mg: _
Each orodispersible tablet contains 30 mg of aripiprazole.
Excipients with known effect
Each orodispersible tablet contains 270.90 mg of lactose (as
monohydrate), 3.0 mg of aspartame, and
up to 0.0108 mg of benzyl alcohol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Orodispersible tablet.
_10 mg: _
Sandoz B.V.
Page 2/28
Aripiprazol Sandoz 10, 15, 30 mg orodispergeerbare
tabletten
RVG 115588, 115589, 115590
1311-V10A
1.3.1.1 Samenvatting van de Productkenmerken
Januari 2023
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.
_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.
_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
[Nationally completed name] is indicated for the treatment of
schizophrenia in adults and in
adolescents aged 15 years and older.
[Nationally completed name] is indicated for t