Aripiprazol GENMED 10 mg orodispergeerbare tabletten

国家: 荷兰

语言: 荷兰文

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

有效成分:

ARIPIPRAZOL 10 mg/stuk

可用日期:

Genmed Pharma GmbH Gabriele-Tergit-Promenade 17 10963 BERLIJN (DUITSLAND)

ATC代码:

N05AX12

INN（国际名称）:

ARIPIPRAZOL 10 mg/stuk

药物剂型:

Orodispergeerbare tablet

组成:

ACESULFAAM KALIUM (E 950) ; ASPARTAAM (E 951) ; CALCIUMSILICAAT (E 552) ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; CROSPOVIDON (E 1202) ; IJZEROXIDE ROOD (E 172) ; MAGNESIUMSTEARAAT (E 470b) ; SILICIUMDIOXIDE (E 551) ; VANILLINE ; WIJNSTEENZUUR, (L (+) Vorm) (E 334) ; XYLITOL (E 967), ACESULFAAM KALIUM (E 950) ; ASPARTAAM (E 951) ; CALCIUMSILICAAT (E 552) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; CROSPOVIDON (E 1202) ; IJZEROXIDE ROOD (E 172) ; MAGNESIUMSTEARAAT (E 470b) ; SILICIUMDIOXIDE (E 551) ; VANILLINE ; WIJNSTEENZUUR, (L (+) Vorm) (E 334) ; XYLITOL (E 967),

给药途径:

Oraal gebruik

治疗领域:

Aripiprazole

產品總結:

Hulpstoffen: ACESULFAAM KALIUM (E 950); ASPARTAAM (E 951); CALCIUMSILICAAT (E 552); CELLULOSE, MICROKRISTALLIJN (E 460); CROSCARMELLOSE NATRIUM (E 468); CROSPOVIDON (E 1202); IJZEROXIDE ROOD (E 172); MAGNESIUMSTEARAAT (E 470b); SILICIUMDIOXIDE (E 551); VANILLINE; WIJNSTEENZUUR, (L (+) Vorm) (E 334); XYLITOL (E 967);

授权日期:

1900-01-01

资料单张

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ARIPIPRAZOL GENMED 10 MG ORODISPERGEERBARE TABLETTEN
ARIPIPRAZOL GENMED 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 GENMED is and what it is used for
2.
What you need to know before you take Aripiprazol GENMED
3.
How to take Aripiprazol GENMED
4.
Possible side effects
5
How to store Aripiprazol GENMED
6.
Contents of the pack and other information
1.
WHAT ARIPIPRAZOL GENMED ORODISPERSIBLE TABLETS ARE AND WHAT THEY ARE
USED FOR
Aripiprazol GENMED orodispersible tablets contain 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.
Aripiprazol GENMED orodispersible tablets are 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 Aripiprazol GENMED orodispersible
tablets.
2.
WHAT YOU NEED T

产品特点

1
1.
NAME OF THE MEDICINAL PRODUCT
Aripiprazol GENMED 10 mg orodispergeerbare tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each orodispersible tablet contains 10 mg of aripiprazole.
Excipient with known effect:
2 mg aspartame (E951) per orodispersible tablet
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Orodispersible tablet
Pale pink, round (Ø 7 mm) tablets
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Aripiprazol GENMED is indicated for the treatment of schizophrenia in
adults and in adolescents
aged 15 years and older.
Aripiprazol GENMED 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 GENMED 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 starting dose for Aripiprazol GENMED 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.
Aripiprazol GENMED 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 maximum daily dose should not exceed 30 mg.
_Manic episodes in Bipolar I Disorder_
: the recommended starting dose for Aripiprazol GENMED is
15 mg administered on a once-a-day schedule without regard to meals as
monotherapy or
combination therapy (see section 5.1). Some patients may benefit from
a higher dose. The maximum
daily dose should not exceed 30 mg.
_Recurrence prevention of manic episodes in Bipolar I Disorder: _
for preventing recurrence of manic
episodes in patients, who have been receiving aripiprazole as
monotherapy