Zyprexa Velotab
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)
03-07-2013
Składnik aktywny:
olanzapine
Dostępny od:
Eli Lilly Nederland B.V.
Kod ATC:
N05AH03
INN (International Nazwa):
olanzapine
Grupa terapeutyczna:
Psycholeptics
Dziedzina terapeutyczna:
Schizophrenia; Bipolar Disorder
Wskazania:
AdultsOlanzapine is indicated for the treatment of schizophrenia.Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response.Olanzapine is indicated for the treatment of moderate to severe manic episode.In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder.
Podsumowanie produktu:
Revision: 31
Status autoryzacji:
Authorised
Data autoryzacji:
2000-02-03
Ulotka dla pacjenta
39
B. PACKAGE LEAFLET
40
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZYPREXA VELOTAB 5 MG ORODISPERSIBLE TABLETS
ZYPREXA VELOTAB 10 MG ORODISPERSIBLE TABLETS
ZYPREXA VELOTAB 15 MG ORODISPERSIBLE TABLETS
ZYPREXA VELOTAB 20 MG ORODISPERSIBLE TABLETS
olanzapine
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 ZYPREXA VELOTAB is and what it is used for
2.
What you need to know before you take ZYPREXA VELOTAB
3.
How to take ZYPREXA VELOTAB
4.
Possible side effects
5.
How to store ZYPREXA VELOTAB
6.
Contents of the pack and other information
1.
WHAT ZYPREXA VELOTAB IS AND WHAT IT IS USED FOR
ZYPREXA VELOTAB contains the active substance olanzapine. ZYPREXA
VELOTAB belongs to a
group of medicines called antipsychotics and is used to treat the
following conditions:
•
Schizophrenia, a disease with symptoms such as hearing, seeing or
sensing things which are not
there, mistaken beliefs, unusual suspiciousness, and becoming
withdrawn. People with this
disease may also feel depressed, anxious or tense.
•
Moderate to severe manic episodes, a condition with symptoms of
excitement or euphoria.
ZYPREXA VELOTAB has been shown to prevent recurrence of these symptoms
in patients with
bipolar disorder whose manic episode has responded to olanzapine
treatment.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZYPREXA VELOTAB
_ _
DO NOT TAKE ZYPREXA VELOTAB
•
If you are allergic (hypersensitive) to olanzapine or any of the other
ingredients of this medicine
(listed in section 6). An allergic reaction may be recognised as a
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
ZYPREXA VELOTAB 5 mg orodispersible tablets
ZYPREXA VELOTAB 10 mg orodispersible tablets
ZYPREXA VELOTAB 15 mg orodispersible tablets
ZYPREXA VELOTAB 20 mg orodispersible tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ZYPREXA VELOTAB 5 mg orodispersible tablets
Each orodispersible tablet contains 5 mg olanzapine.
Excipients with known effect: Each orodispersible tablet contains
0.60 mg aspartame (E951),
0.1125 mg sodium methyl parahydroxybenzoate (E219),
0.0375 mg sodium propyl parahydroxybenzoate (E217).
ZYPREXA VELOTAB 10 mg orodispersible tablets
Each orodispersible tablet contains 10 mg olanzapine.
Excipients with known effect: Each orodispersible tablet contains
0.80 mg aspartame (E951),
0.15 mg sodium methyl parahydroxybenzoate (E219),
0.05 mg sodium propyl parahydroxybenzoate (E217).
ZYPREXA VELOTAB 15 mg orodispersible tablets
Each orodispersible tablet contains 15 mg olanzapine.
Excipients with known effect: Each orodispersible tablet contains
1.20 mg aspartame (E951),
0.225 mg sodium methyl parahydroxybenzoate (E219),
0.075 mg sodium propyl parahydroxybenzoate
(E217)
.
ZYPREXA VELOTAB 20 mg orodispersible tablets
Each orodispersible tablet contains 20 mg olanzapine.
Excipients with known effect: Each orodispersible tablet contains
1.60 mg aspartame (E951),
0.30 mg sodium methyl parahydroxybenzoate (E219),
0.10 mg sodium propyl parahydroxybenzoate (E217).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Orodispersible tablet
Yellow, round, freeze dried, rapid-dispersing preparation to be placed
in the mouth or alternatively to
be dispersed in water or other suitable beverage for administration.
_ _
_ _
3
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_Adults _
Olanzapine is indicated for the treatment of schizophrenia.
Olanzapine is effective in maintaining the clinical improvement during
continuation therapy in
patients who have shown an initial treatment response.
Olanzapine is indicated fo
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