APO-OLANZAPINE ODT olanzapine 5 mg orally disintegrating tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

olanzapine, Quantity: 5 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Olanzapine

Pharmaceutical form:

Tablet, orally disintegrating

Composition:

Excipient Ingredients: microcrystalline cellulose; magnesium stearate; colloidal anhydrous silica; carmellose calcium; sucralose; mannitol

Administration route:

Oral

Units in package:

28

Prescription type:

(S4) Prescription Only Medicine

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.

Product summary:

Visual Identification: Yellow, round, flat, faced radial edge tablets. Engraved "APO" on one side, "OL" over "5" on the other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2009-11-26

Patient Information leaflet

APO-OLANZAPINE ORALLY
DISINTEGRATING TABLETS
_ORALLY DISINTEGRATING 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 c

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – APO-OLANZAPINE ODT
ORALLY DISINTEGRATING TABLETS (OLANZAPINE)
1
NAME OF THE MEDICINE
Olanzapine
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each orally disintegrating tablet contains 5mg, 10mg, 15mg or 20mg
olanzapine, as the active
ingredient.
EXCIPIENTS WITH KNOWN EFFECT
Not applicable
For the full list of excipients see section 6.1 List of Excipients
3
PHARMACEUTICAL FORM
5MG ORALLY DISINTEGRATING TABLETS:
Yellow, round, flat face radial-edged tablets. Engraved “APO” on
one side, “OL” over “5” on
the other side.
10MG ORALLY DISINTEGRATING TABLETS:
Yellow, round, flat face radial-edged tablets. Engraved “APO” on
one side, “OL” over “10” on
the other side.
15MG ORALLY DISINTEGRATING TABLETS:
Yellow, round, flat face radial-edged tablets. Engraved “APO” on
one side, “OL” over “15” on
the other side.
20MG ORALLY DISINTEGRATING TABLETS:
Yellow, round, flat face radial-edged tablets. Engraved “APO” on
one side, “OL” over “20” on
the other side.
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.
2
4.2
DOSE AND METHOD OF ADMINISTRATION
Olanzapine ODT orally disintegrating tablets are intended for oral
administration.
The orally disintegrating tablet begins disintegrating in the mouth
within seconds, allowing its
contents to be subsequently swallowed with or without liquid.
The orally disintegrating tablet should be handled carefully with dry
hands. Direct contact with
hands should be avoided if possible. The orally disintegrating tablet
may also be stirred into
125mL of water, milk, coffee, orange juice or apple juice and the
contents promptly consumed.
SCHIZOPHRENIA AND RELATED DISORDERS
The recommended starting dose is 5 to 10mg/day, administered as a
single d