Aripiprazole Zentiva

Land: Den Europæiske Union

Sprog: engelsk

Kilde: EMA (European Medicines Agency)

Aktiv bestanddel:

aripiprazole

Tilgængelig fra:

Zentiva, k.s.

ATC-kode:

N05AX12

INN (International Name):

aripiprazole

Terapeutisk gruppe:

Psycholeptics

Terapeutisk område:

Schizophrenia; Bipolar Disorder

Terapeutiske indikationer:

Aripiprazole Zentiva is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older.Aripiprazole Zentiva 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.Aripiprazole Zentiva 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.

Produkt oversigt:

Revision: 9

Autorisation status:

Authorised

Autorisation dato:

2015-06-25

Indlægsseddel

75
B. PACKAGE LEAFLET
76
PACKAGE LEAFLET: INFORMATION FOR THE USER
ARIPIPRAZOLE ZENTIVA 5 MG TABLETS
ARIPIPRAZOLE ZENTIVA 10 MG TABLETS
ARIPIPRAZOLE ZENTIVA 15 MG TABLETS
ARIPIPRAZOLE ZENTIVA 30 MG TABLETS
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 Aripiprazole Zentiva is and what it is used for
2.
What you need to know before you take Aripiprazole Zentiva
3.
How to take Aripiprazole Zentiva
4.
Possible side effects
5.
How to store Aripiprazole Zentiva
6.
Contents of the pack and other information
1.
WHAT ARIPIPRAZOLE ZENTIVA IS AND WHAT IT IS USED FOR
Aripiprazole Zentiva 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.
Aripiprazole Zentiva 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
Aripiprazole Zentiva.
2.
WHAT YOU NEED TO KNOW BEFORE YOU T

Produktets egenskaber

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Aripiprazole Zentiva 5 mg tablets
Aripiprazole Zentiva 10 mg tablets
Aripiprazole Zentiva 15 mg tablets
Aripiprazole Zentiva 30 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Aripiprazole Zentiva 5 mg tablets
Each tablet contains 5 mg of aripiprazole.
Excipient with known effect
Each tablet contains 33 mg of lactose (as monohydrate).
Aripiprazole Zentiva 10 mg tablets
Each tablet contains 10 mg of aripiprazole.
Excipient with known effect
Each tablet contains 66 mg of lactose (as monohydrate).
Aripiprazole Zentiva 15 mg tablets
Each tablet contains 15 mg of aripiprazole.
Excipient with known effect
Each tablet contains 99 mg of lactose (as monohydrate).
Aripiprazole Zentiva 30 mg tablets
Each tablet contains 30 mg of aripiprazole.
Excipient with known effect
Each tablet contains 198 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
Aripiprazole Zentiva 5 mg tablets
White to off-white round flat bevel edged uncoated tablets with
‘5’ debossed on one side and plain
on the other side with diameter approx. 6 mm.
3
Aripiprazole Zentiva 10 mg tablets
White to off-white round uncoated tablets with ‘10’ debossed on
one side and snap tab breakline
on the other side with diameter approx. 8 mm.
The score line is not intended for breaking the tablet.
Aripiprazole Zentiva 15 mg tablets
White to off-white round flat bevel edged uncoated tablets with
‘15’ debossed on one side and plain
on the other side with diameter approx. 8.8 mm.
Aripiprazole Zentiva 30 mg tablets
White to off-white capsule shaped uncoated tablets with ‘30’
debossed on one side and snap tab
breakline on the other side with dimensions approx. 15.5 x 8 mm.
The score line is not intended for breaking the tablet.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Aripiprazole Zentiva is indicated for the treatment of schizophrenia
in adults and in adolescents aged
15 years and older.
Aripiprazole Ze