Olanzapine Glenmark Europe
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
20-12-2022
Charakterystyka produktu
(SPC)
20-12-2022
Sprawozdanie z oceny publicznego
(PAR)
29-01-2010
Składnik aktywny:
olanzapine
Dostępny od:
Glenmark Arzneimittel GmbH
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: 14
Status autoryzacji:
Authorised
Data autoryzacji:
2009-12-03
Ulotka dla pacjenta
80
B. PACKAGE LEAFLET
81
PACKAGE LEAFLET: INFORMATION FOR THE USER
Olanzapine Glenmark Europe 5 mg orodispersible tablets
Olanzapine Glenmark Europe 10 mg orodispersible tablets
Olanzapine Glenmark Europe 15 mg orodispersible tablets
Olanzapine Glenmark Europe 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 Olanzapine Glenmark Europe is and what it is used for
2.
What you need to know before you take Olanzapine Glenmark Europe
3.
How to take Olanzapine Glenmark Europe
4.
Possible side effects
5.
How to store Olanzapine Glenmark Europe
6.
Contents of the pack and other information
1.
WHAT OLANZAPINE GLENMARK EUROPE IS AND WHAT IT IS USED FOR
Olanzapine Glenmark Europe contains the active substance olanzapine.
Olanzapine Glenmark Europe
belongs to a group of medicines called antipsychotics.
Olanzapine Glenmark Europe 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
Olanzapine Glenmark Europe 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 OLANZAPINE GLENMARK EUROPE
DO NOT TAKE OLANZAPINE GLENMARK EUROP
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Olanzapine Glenmark Europe 5 mg orodispersible tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each orodispersible tablet contains 5 mg olanzapine.
Excipient with known effect: Each orodispersible tablet contains 0.23
mg of aspartame
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Orodispersible tablet
Yellow coloured circular flat bevelled edge tablets with ‘B’
debossed on one side.
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 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 (see
section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Adults_
Schizophrenia: The recommended starting dose for olanzapine is 10
mg/day.
Manic episode: The starting dose is 15 mg as a single daily dose in
monotherapy or 10 mg daily in
combination therapy (see section 5.1).
Preventing recurrence in bipolar disorder: The recommended starting
dose is 10 mg/day. For patients
who have been receiving olanzapine for treatment of manic episode,
continue therapy for preventing
recurrence at the same dose. If a new manic, mixed, or depressive
episode occurs, olanzapine
treatment should be continued (with dose optimisation as needed), with
supplementary therapy to treat
mood symptoms, as clinically indicated.
During treatment for schizophrenia, manic episode and recurrence
prevention in bipolar disorder,
daily dosage may subsequently be adjusted on the basis of individual
clinical status within the range
5-20 mg/day. An increase to a dose greater than the recommended
starting dose is advised only after
appropriate clinical r
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