Aripiprazole Sandoz
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
27-02-2024
Charakterystyka produktu
(SPC)
27-02-2024
Sprawozdanie z oceny publicznego
(PAR)
25-09-2015
Składnik aktywny:
aripiprazole
Dostępny od:
Sandoz GmbH
Kod ATC:
N05AX12
INN (International Nazwa):
aripiprazole
Grupa terapeutyczna:
Psycholeptics
Dziedzina terapeutyczna:
Schizophrenia; Bipolar Disorder
Wskazania:
Aripiprazole Sandoz is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older. Aripiprazole Sandoz 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 Sandoz 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: 9
Status autoryzacji:
Authorised
Data autoryzacji:
2015-08-20
Ulotka dla pacjenta
54
B. PACKAGE LEAFLET
55 PACKAGE LEAFLET: INFORMATION FOR THE USER
ARIPIPRAZOLE SANDOZ 5 MG TABLETS
ARIPIPRAZOLE SANDOZ 10 MG TABLETS
ARIPIPRAZOLE SANDOZ 15 MG TABLETS
ARIPIPRAZOLE SANDOZ 20 MG TABLETS
ARIPIPRAZOLE SANDOZ 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 Sandoz tablets are and what they are used for
2.
What you need to know before you take Aripiprazole Sandoz tablets
3.
How to take Aripiprazole Sandoz tablets
4.
Possible side effects
5.
How to store Aripiprazole Sandoz tablets
6.
Contents of the pack and other information
1.
WHAT ARIPIPRAZOLE SANDOZ IS AND WHAT IT IS USED FOR
Aripiprazole Sandoz 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 Sandoz 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 w
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Aripiprazole Sandoz 5 mg tablets
Aripiprazole Sandoz 10 mg tablets
Aripiprazole Sandoz 15 mg tablets
Aripiprazole Sandoz 20 mg tablets
Aripiprazole Sandoz 30 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Aripiprazole Sandoz 5 mg tablets
Each tablet contains 5 mg of aripiprazole.
Excipient with known effect
67.47 mg lactose (as monohydrate) per tablet.
Aripiprazole Sandoz 10 mg tablets
Each tablet contains 10 mg of aripiprazole.
Excipient with known effect
62.67 mg lactose (as monohydrate) per tablet.
Aripiprazole Sandoz 15 mg tablets
_ _
Each tablet contains 15 mg of aripiprazole.
Excipient with known effect
92.86 mg lactose (as monohydrate) per tablet.
Aripiprazole Sandoz 20 mg tablets
Each tablet contains 20 mg of aripiprazole.
Excipient with known effect
125.72 mg lactose (as monohydrate) per tablet.
Aripiprazole Sandoz 30 mg tablets
Each tablet contains 30 mg of aripiprazole.
Excipient with known effect
186.68 mg lactose (as monohydrate) per tablet.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
Aripiprazole Sandoz 5 mg tablets
3
Blue coloured, mottled, round shaped tablet, with an approximate
diameter of 6.0 mm, debossed with “SZ”
on one side and “444” on the other side.
Aripiprazole Sandoz 10 mg tablets
Pink coloured, mottled, round shaped tablet, with an approximate
diameter of 6.0 mm, debossed with “SZ”
on one side and “446” on the other side.
Aripiprazole Sandoz 15 mg tablets
Yellow coloured, mottled, round shaped tablet, with an approximate
diameter of 7.0 mm, debossed with
“SZ” on one side and “447” on the other side.
Aripiprazole Sandoz 20 mg tablets
White coloured, round shaped tablet, with an approximate diameter of
7.8 mm, debossed with “SZ” on one
side and “448” on the other side.
_ _
_ _
Aripiprazole Sandoz 30 mg tablets
Pink coloured, mottled, round shaped tablet, with an approximate
diameter of 9.0 mm, debossed with “SZ”
on one side and
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