Aripiprazole Accord
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
03-11-2022
Charakterystyka produktu
(SPC)
03-11-2022
Sprawozdanie z oceny publicznego
(PAR)
27-11-2015
Składnik aktywny:
aripiprazole
Dostępny od:
Accord Healthcare S.L.U.
Kod ATC:
N05AX12
INN (International Nazwa):
aripiprazole
Grupa terapeutyczna:
Psycholeptics
Dziedzina terapeutyczna:
Schizophrenia; Bipolar Disorder
Wskazania:
Aripiprazole Accord is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older. Aripiprazole Accord 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 Accord 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: 15
Status autoryzacji:
Authorised
Data autoryzacji:
2015-11-15
Ulotka dla pacjenta
44
B. PACKAGE LEAFLET
45
PACKAGE LEAFLET: INFORMATION FOR THE USER
ARIPIPRAZOLE ACCORD 5 MG TABLETS
ARIPIPRAZOLE ACCORD 10 MG TABLETS
ARIPIPRAZOLE ACCORD 15 MG TABLETS
ARIPIPRAZOLE ACCORD 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 Accord is and what it is used for
2.
What you need to know before you take Aripiprazole Accord
3.
How to take Aripiprazole Accord
4.
Possible side effects
5
How to store Aripiprazole Accord
6.
Contents of the pack and other information
1.
WHAT ARIPIPRAZOLE ACCORD IS AND WHAT IT IS USED FOR
Aripiprazole Accord 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.
This medicine 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 this
medicine.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ARIPIPRAZOLE ACCO
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Aripiprazole Accord 5 mg tablets
Aripiprazole Accord 10 mg tablets
Aripiprazole Accord 15 mg tablets
Aripiprazole Accord 30 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Aripiprazole Accord 5 mg tablets
Each tablet contains 5 mg of aripiprazole.
Excipient with known effect
Each 5 mg tablet contains 63 mg lactose (as monohydrate).
_ _
Aripiprazole Accord 10 mg tablets
Each tablet contains 10 mg of aripiprazole.
Excipient with known effect
Each 10 mg tablet contains 59 mg lactose (as monohydrate).
Aripiprazole Accord 15 mg tablets
Each tablet contains 15 mg of aripiprazole.
Excipient with known effect
Each 15 mg tablet contains 88 mg lactose (as monohydrate).
Aripiprazole Accord 30 mg tablets
Each tablet contains 30 mg of aripiprazole.
Excipient with known effect
Each 30 mg tablet contains 177 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
Aripiprazole Accord 5 mg tablets
Blue colored, approximately 8.1 mm in length, 4.6 mm in width,
modified rectangle shaped, biconvex,
uncoated tablets, debossed with “A5” on one side and another side
is plain.
Aripiprazole Accord 10 mg tablets
Pink colored, approximately 8.1 mm in length, 4.6 mm in width,
modified rectangle shaped, biconvex,
3
uncoated tablets, debossed with “A10” on one side and another side
is plain.
Aripiprazole Accord 15 mg tablets
Yellow colored, approximately 7.14 mm in diameter, round shaped,
bevelled edge, biconvex, uncoated
tablets, debossed with “A15” on one side and another side is
plain.
Aripiprazole Accord 30 mg tablets
Pink colored, approximately 9.1 mm in diameter, round shaped, bevelled
edge, biconvex, uncoated
tablets, debossed with “A30” on one side and another side is
plain.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Aripiprazole Accord is indicated for the treatment of schizophrenia in
adults and in adolescents aged
15 years and older.
Aripiprazole Accord is indicated for
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