APO-OLANZAPINE olanzapine 10 mg film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

olanzapine

Available from:

Apotex Pty Ltd

INN (International Name):

Olanzapine

Authorization status:

Registered

Patient Information leaflet

APO-OLANZAPINE FILM COATED TABLETS
1
APO-OLANZAPINE FILM
COATED TABLETS
_Olanzapine _
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about this medicine. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is APO-
Olanzapine. It contains the active
ingredient olanzapine.
Olanzapine belongs to a group of
medicines called antipsychotics. It
helps to correct chemical imbalances
in the brain, which may cause mental
illness.
It is used:
•
to treat symptoms of
schizophrenia and related
psychoses
•
alone, or in combination with
lithium or valproate, for the short-
term treatment of acute manic
episodes associated with Bipolar I
Disorder.
•
as a mood stabiliser that prevents
further occurrences of high and
low (depressed) extremes of
mood associated with Bipolar I
Disorder.
Schizophrenia is a mental illness
with disturbances in thinking,
feelings and behaviour. Bipolar I
Disorder is a mental illness with
symptoms such as feeling "high",
having excessive amounts of energy,
needing much less sleep than usual,
talking very quickly with racing
ideas and sometimes severe
irritability.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
This medicine may affect your ability
to drive a car or operate machinery.
There is no evidence that this
medicine is addictive.
_USE IN CHILDREN _
Olanzapine is not recommended for
use in ch

Summary of Product characteristics

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AUSTRALIAN PRODUCT INFORMATION –
APO-OLANZAPINE FILM COATED TABLETS (OLANZAPINE)
1
NAME OF THE MEDICINE
Olanzapine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains 2.5mg, 5mg, 7.5mg, 10mg, 15mg or 20mg
olanzapine, as
the active ingredient.
EXCIPIENTS WITH KNOWN EFFECT
Olanzapine film coated tablets contain lactose monohydrate.
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS
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PHARMACEUTICAL FORM
2.5MG FILM COATED TABLETS:
White, round, biconvex film-coated tablet. Engraved “APO” on one
side, “OLA” over “2.5” on
the other side.
5MG FILM COATED TABLETS:
White, round, biconvex film-coated tablet. Engraved “APO” on one
side, “OLA” over “5” on
the other side.
7.5MG FILM COATED TABLETS:
White, round, biconvex film-coated tablet. Engraved “APO” on one
side, “OLA” over “7.5” on
the other side.
10MG FILM COATED TABLETS:
White, round, biconvex film-coated tablet. Engraved “APO” on one
side, “OLA” over “10” on
the other side.
15MG FILM COATED TABLETS:
Light blue, elliptical, biconvex film-coated tablet. Engraved
“APO” on one side, “OLA 15” on
the other side.
20MG FILM COATED TABLETS:
Light pink, elliptical, biconvex film-coated tablet. Engraved
“APO” on one side, “OLA 20” on
the other side.
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4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
Treatment of schizophrenia and related psychoses;
•
Short-term treatment, alone or in combination with lithium or
valproate, of acute manic
episodes associated with bipolar I disorder;
•
Preventing recurrence of manic, mixed or depressive episodes in
Bipolar I Disorder.
4.2
DOSE AND METHOD OF ADMINISTRATION
Olanzapine film coated tablets are intended for oral administration.
SCHIZOPHRENIA AND RELATED DISORDERS
The recommended starting dose is 5 to 10mg/day, administered as a
single daily dose
without regard to meals. Daily dosage may subsequently be adjusted on
the basis of
individual clinical status within the range of 5 to 20mg daily. An
increase to a dose greater