Olanzapine Apotex

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

olanzapine

Saatavilla:

Apotex Europe BV

ATC-koodi:

N05AH03

INN (Kansainvälinen yleisnimi):

olanzapine

Terapeuttinen ryhmä:

Psycholeptics

Terapeuttinen alue:

Schizophrenia; Bipolar Disorder

Käyttöaiheet:

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.

Tuoteyhteenveto:

Revision: 13

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2010-06-10

Pakkausseloste

158
B. PACKAGE LEAFLET
159
PACKAGE LEAFLET: INFORMATION FOR THE USER
OLANZAPINE APOTEX 2.5 MG FILM-COATED TABLETS
OLANZAPINE APOTEX 5 MG FILM-COATED TABLETS
OLANZAPINE APOTEX 7.5 MG FILM-COATED TABLETS
OLANZAPINE APOTEX 10 MG FILM-COATED TABLETS
Olanzapine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 Apotex is and what it is used for
2.
What you need to know before you take Olanzapine Apotex
3.
How to take Olanzapine Apotex
4.
Possible side effects
5.
How to store Olanzapine Apotex
6.
Contents of the pack and other information
1.
WHAT OLANZAPINE APOTEX IS AND WHAT IT IS USED FOR
Olanzapine Apotex contains the active substance olanzapine. Olanzapine
Apotex 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withdrawn.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.
Olanzapine Apotex 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 APOTEX
DO NOT TAKE OLANZAPINE APOTEX

If you are allergic (hypersensitive) to olanzapine or any of the other
ingredients of this medicine
(listed in section 6). An allergic reaction

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Olanzapine Apotex 2.5 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 2.5 mg olanzapine.
Excipient with known effect: Each film-coated tablet contains 63.17 mg
lactose.
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Film-coated tablet
White, round, biconvex film-coated tablets engraved ‘APO’ on one
side and ‘OLA’ over ‘2.5’
on the other 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 ap