Aripiprazol Doc Generici 10 mg, orodispergeerbare tabletten

Страна: Нидерландия

Език: нидерландски

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

Активна съставка:

ARIPIPRAZOL

Предлага се от:

DOC Generici S.r.l. Via Filippo Turati 40 20121 MILANO (ITALIË)

АТС код:

N05AX12

INN (Международно Name):

ARIPIPRAZOLE

Лекарствена форма:

Orodispergeerbare tablet

Композиция:

ACESULFAAM KALIUM (E 950) ; ASPARTAAM (E 951) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; CROSPOVIDON (E 1202) ; IJZEROXIDE ROOD (E 172) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; SILICIUMDIOXIDE (E 551) ; VANILLINE ; WIJNSTEENZUUR (D-,L-),

Начин на приложение:

Oraal gebruik

Терапевтична област:

Aripiprazole

Каталог на резюме:

Hulpstoffen: ACESULFAAM KALIUM (E 950); ASPARTAAM (E 951); CELLULOSE, MICROKRISTALLIJN (E 460); CROSCARMELLOSE NATRIUM (E 468); CROSPOVIDON (E 1202); IJZEROXIDE ROOD (E 172); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); SILICIUMDIOXIDE (E 551); VANILLINE; WIJNSTEENZUUR (D-,L-);

Дата Оторизация:

2015-07-21

Листовка

_02/2016 – NL MA approval; 03/2016 –NL approval var. 02 –
12/2016 – Nl approval var. 05; 06/2019 – NL approval var. 08;
12/2019 – _
_NL approval var. 07 – proposed var. 010 _
PACKAGE LEAFLET: INFORMATION FOR THE USER
ARIPIPRAZOL DOC GENERICI 10 MG, ORODISPERGEERBARE TABLETTEN
ARIPIPRAZOL DOC GENERICI 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 Doc Generici are and what it is used for
2.
What you need to know before you take Aripiprazol Doc Generici
3.
How to take Aripiprazol Doc Generici
4.
Possible side effects
5.
How to store Aripiprazol Doc Generici
6.
Contents of the pack and other information
1
WHAT ARIPIPRAZOL DOC GENERICI IS AND WHAT IT IS USED FOR
ARIPIPRAZOL DOC GENERICI
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.
Aripiprazol Doc Generici 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 irritab

Данни за продукта

_02/2016 – NL MA approval; 03/2016 –NL approval var. 02;12/2016
– NL approval var. 05;06/2019 – NL approval var. 08; 12/2019 – _
_NL approval var. 07; proposed var. 010 _
_ _
1.
NAME OF THE MEDICINAL PRODUCT
Aripiprazol Doc Generici 10 mg, orodispergeerbare tabletten
Aripiprazol Doc Generici 15 mg, orodispergeerbare tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Aripiprazol Doc Generici 10 mg orodispersible tablet contains 10
mg of aripiprazole.
Each Aripiprazol Doc Generici 15 mg orodispersible tablet contains 15
mg of aripiprazole.
Excipient with known effect:
72.6 mg lactose monohydrate per orodispersible tablet
2.1 mg aspartame (E951) per orodispersible tablet
0.24 mg glucose per orodispersible tablet
Sodium
108.9 mg lactose monohydrate per orodispersible tablet
3.1 mg aspartame (E951) per orodispersible tablet
0.35 mg glucose per orodispersible tablet
Sodium
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Orodispersible tablet
Round (approximately 7 mm) and pink, with possible darker spots,
engraved with “AD10” on one side
Round (approximately 8 mm) and yellow, with possible darker spots,
engraved with “AD15” on one side
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Aripiprazol Doc Generici is indicated for the treatment of
schizophrenia in adults and in adolescents aged 15
years and older.
Aripiprazol Doc Generici 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 Doc Generici 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 Doc
Generici is 10 or 15 mg/day with a
maintenance dose of 15 mg