Olanzapine Glenmark
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
20-12-2022
Valmisteyhteenveto
(SPC)
20-12-2022
Julkisesta arviointikertomuksesta
(PAR)
26-08-2014
Aktiivinen ainesosa:
olanzapine
Saatavilla:
Glenmark Arzneimittel GmbH
ATC-koodi:
N05AH03
INN (Kansainvälinen yleisnimi):
olanzapine
Terapeuttinen ryhmä:
Psycholeptics
Terapeuttinen alue:
Schizophrenia; Bipolar Disorder
Käyttöaiheet:
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.
Tuoteyhteenveto:
Revision: 15
Valtuutuksen tilan:
Authorised
Valtuutus päivämäärä:
2009-12-03
Pakkausseloste
122
B. PACKAGE LEAFLET
123
PACKAGE LEAFLET: INFORMATION FOR THE USER
Olanzapine Glenmark 2.5 mg tablets
Olanzapine Glenmark 5 mg tablets
Olanzapine Glenmark 7.5 mg tablets
Olanzapine Glenmark 10 mg tablets
Olanzapine Glenmark 15 mg tablets
Olanzapine Glenmark 20 mg 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 is and what it is used for
2.
What you need to know before you take Olanzapine Glenmark
3.
How to take Olanzapine Glenmark
4.
Possible side effects
5.
How to store Olanzapine Glenmark
6.
Contents of the pack and other information
1.
WHAT OLANZAPINE GLENMARK IS AND WHAT IT IS USED FOR
Olanzapine Glenmark contains the active substance olanzapine.
Olanzapine Glenmark belongs to a
group of medicines called antipsychotics.
Olanzapine Glenmark 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 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
DO NOT TAKE OLANZAPINE GLENMARK
-
if you are allergic (hypersensitive) to olanzapine or any of the other
ingredients of thi
Lue koko asiakirja
Valmisteyhteenveto
1
_ _
_ _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Olanzapine Glenmark 2.5 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2.5 mg olanzapine.
Excipient with known effect: Each tablet contains 0.23 mg of aspartame
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
Yellow coloured circular flat bevelled edge tablets with ‘A’
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 reassessment and should generally occur at
intervals of
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