APO-OLANZAPINE olanzapine 2.5 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

olanzapine, Quantity: 2.5 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: microcrystalline cellulose; lactose; hyprolose; magnesium stearate

Administration route:

Oral

Units in package:

28

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

APO-OLANZAPINE tablets are indicated for ? 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 1 disorder.

Product summary:

Visual Identification: Light yellow to yellow coloured, slightly mottled, round, biconvex tablets, debossed with 'O4' on one side and plain on the other side.; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2018-08-29

Patient Information leaflet

OLANZAPINE APOTEX TABLETS
1
OLANZAPINE APOTEX
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 olanzapine. 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 using 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 want to read it again.
WHAT THIS MEDICINE IS
USED FOR
Olanzapine belongs to a group of
medicines called antipsychotics.
Olanzapine 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 the
disabling high and low extremes
of mood associated Bipolar I
Disorder
_HOW IT WORKS _
Olanzapine helps to correct chemical
imbalances in the brain, which may
cause mental illness.
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 is not addictive.
There is not enough information to
recommend using olanzapine in
children under the age of 18 years.
BEFORE YOU TAKE THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
olanzapine
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue,
throat or other parts of the body
•
rash, itching or hives on the skin;
DO NOT TAKE THIS MEDICINE AFTER THE
EX

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
OLANZAPINE APOTEX
(OLANZAPINE) TABLETS
1
NAME OF THE MEDICINE
Olanzapine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
OLANZAPINE APOTEX 2.5 mg uncoated tablet contains olanzapine 2.5 mg.
Excipient with known effects: Each 2.5 mg tablet contains 65.5 mg of
lactose.
OLANZAPINE APOTEX 5 mg uncoated tablet contains olanzapine 5 mg.
Excipient with known effects: Each 5 mg tablet contains 131 mg of
lactose.
OLANZAPINE APOTEX 7.5 mg uncoated tablet contains olanzapine 7.5 mg.
Excipient with known effects: Each 7.5 mg tablet contains 196.5 mg of
lactose.
OLANZAPINE APOTEX 10 mg uncoated tablet contains olanzapine 10 mg.
Excipient with known effects: Each 10 mg tablet contains 262 mg of
lactose.
For the full list of excipients, see Section 6.1 List of excipients.
3 PHARMACEUTICAL FORM
Tablet.
2.5 mg:
Light yellow to yellow coloured, slightly mottled, round, biconvex
tablets debossed
with ‘O4’ on one side and plain on the other side.
5 mg: Light yellow to yellow coloured, slightly mottled, round,
biconvex tablets debossed
with ‘O5’ on one side and plain on the other side.
7.5 mg: Light yellow to yellow coloured, slightly mottled, round,
biconvex tablets debossed
with ‘O6’ on one side and plain on the other side.
10 mg: light yellow to yellow coloured, slightly mottled, round,
biconvex tablets debossed
with ‘O7’ on one side and plain on the other side.
2
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
OLANZAPINE APOTEX tablets are indicated for
•
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 1 disorder.
4.2
DOSE AND METHOD OF ADMINISTRATION
OLANZAPINE APOTEX tablets are intended for oral administration
SCHIZOPHRENIA AND RELATED DISORDERS
The recommended starting dose for olanzapine tablets is 5 to 10mg/day,
administered as a
single daily dose without regard to