Olanzapine Cipla (previously Olanzapine Neopharma)

Land: Den Europæiske Union

Sprog: engelsk

Kilde: EMA (European Medicines Agency)

Aktiv bestanddel:

olanzapine

Tilgængelig fra:

Cipla (EU) Limited

ATC-kode:

N05AH03

INN (International Name):

olanzapine

Terapeutisk gruppe:

Psycholeptics

Terapeutisk område:

Schizophrenia; Bipolar Disorder

Terapeutiske indikationer:

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.

Produkt oversigt:

Revision: 12

Autorisation status:

Withdrawn

Autorisation dato:

2007-11-14

Indlægsseddel

Medicinal product no longer authorised
101
B. PACKAGE LEAFLET
Medicinal product no longer authorised
102
PACKAGE LEAFLET: INFORMATION FOR THE USER
OLANZAPINE CIPLA 2.5 MG COATED TABLETS
OLANZAPINE CIPLA 5 MG COATED TABLETS
OLANZAPINE CIPLA 7.5 MG COATED TABLETS
OLANZAPINE CIPLA 10 MG COATED TABLETS
OLANZAPINE CIPLA 15 MG COATED 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.
What is in this leaflet
1.
What OLANZAPINE CIPLA is and what it is used for
2.
What you need to know before you take OLANZAPINE CIPLA
3.
How to take OLANZAPINE CIPLA
4.
Possible side effects
5.
How to store OLANZAPINE CIPLA
6.
Contents of the pack and other information
1.
WHAT OLANZAPINE CIPLA IS AND WHAT IT IS USED FOR
OLANZAPINE CIPLA 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withdrawn.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 CIPLA 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 CIPLA
_ _
DO NOT TAKE OLANZAPINE CIPLA

iIf you are allergic (hypersensitive) to olanzapine or any of the
other ingredients of this medicine
(listed in section 6). An allergic re

Produktets egenskaber

Medicinal product no longer authorised
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Olanzapine Cipla 2.5 mg coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each coated tablet contains 2.5 mg olanzapine.
Excipient with known effect: Each coated tablet contains 80.7 mg
lactose monohydrate
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Coated tablet
White, round, biconvex, coated tablets with ‘2.5’ debossing on one
side and ‘OLZ’ on the other.
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 reco