Abilify
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
08-04-2022
Charakterystyka produktu
(SPC)
08-04-2022
Sprawozdanie z oceny publicznego
(PAR)
27-01-2017
Składnik aktywny:
aripiprazole
Dostępny od:
Otsuka Pharmaceutical Netherlands B.V.
Kod ATC:
N05AX12
INN (International Nazwa):
aripiprazole
Grupa terapeutyczna:
Psycholeptics
Dziedzina terapeutyczna:
Schizophrenia; Bipolar Disorder
Wskazania:
Abilify is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older.Abilify 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.Abilify 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.
Podsumowanie produktu:
Revision: 49
Status autoryzacji:
Authorised
Data autoryzacji:
2004-06-04
Ulotka dla pacjenta
107
B. PACKAGE LEAFLET
108
PACKAGE LEAFLET: INFORMATION FOR THE USER
ABILIFY 5 MG TABLETS
ABILIFY 10 MG TABLETS
ABILIFY 15 MG TABLETS
ABILIFY 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 ABILIFY is and what it is used for
2.
What you need to know before you take ABILIFY
3.
How to take ABILIFY
4.
Possible side effects
5
How to store ABILIFY
6.
Contents of the pack and other information
1.
WHAT ABILIFY IS AND WHAT IT IS USED FOR
ABILIFY 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.
ABILIFY 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 ABILIFY.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ABILIFY
DO NOT TAKE ABILIFY
•
if you are allergic to aripiprazole or any of the other ingredients of
this medicine (listed in
section 6).
WARNING
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
ABILIFY 5 mg tablets
ABILIFY 10 mg tablets
ABILIFY 15 mg tablets
ABILIFY 30 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ABILIFY 5
mg tablets
Each tablet contains 5 mg of aripiprazole.
Excipient with known effect
63.65 mg lactose (as monohydrate) per tablet
_ _
ABILIFY 10
mg tablets
Each tablet contains 10 mg of aripiprazole.
Excipient with known effect
59.07 mg lactose (as monohydrate) per tablet
ABILIFY 15
mg tablets
Each tablet contains 15 mg of aripiprazole.
Excipient with known effect
54.15 mg lactose (as monohydrate) per tablet
ABILIFY 30
mg tablets
Each tablet contains 30 mg of aripiprazole.
Excip
ient with known effect
177.22 mg lactose (as monohydrate) per tablet
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
ABILIFY 5
mg tablets
Rectangular and blue, engraved with "A-007" and "5" on one side.
ABILIFY 10 mg tablets
Rectangular and pink, engraved with "A-008" and "10" on one side.
ABILIFY 15
mg tablets
Round and yellow, engraved with "A-009" and "15" on one side.
ABILIFY 30
mg tablets
Round and pink, engraved with "A-011" and "30" on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ABILIFY is indicated for the treatment of schizophrenia in adults and
in adolescents aged 15 years
and older.
3
ABILIFY 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).
ABILIFY 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 ABILIFY is 10 mg/day or 15 mg/day
with a
maintenance dose of 15 mg/day administered on a once-a-day schedule
without regard to
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