OLANZAPINE RBX olanzapine 10 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

olanzapine, Quantity: 10 mg

Available from:

Sun Pharma ANZ Pty Ltd

INN (International Name):

Olanzapine

Pharmaceutical form:

Tablet, uncoated

Composition:

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

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: Light yellow to yellow coloured, slightly mottled, round, biconvex tablets, debossed with 'O7' 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:

2011-03-11

Patient Information leaflet

OLANZAPINE RBX CMI V6 May 2020
Page 1 of 10
OLANZAPINE RBX TABLETS
Olanzapine
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about OLANZAPINE RBX.
It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist.
This leaflet was last updated on the date at the end of this leaflet.
More recent information may be available. The latest Consumer Medicine
Information is available from https://www.ebs.tga.gov.au/ and may
contain important information about the medicine and its use of which
you should be aware.
All medicines have risks and benefits. Your doctor has weighed the
risks of you taking OLANZAPINE RBX against the benefits it is expected
to 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 OLANZAPINE RBX IS USED FOR
The name of your medicine is OLANZAPINE RBX. OLANZAPINE RBX contains
olanzapine as the active ingredient. Olanzapine belong to a group of
medicines called antipsychotics. OLANZAPINE RBX helps to correct
chemical imbalances in the brain which may cause mental illness.
OLANZAPINE RBX is used to treat symptoms of schizophrenia and related
psychoses. Schizophrenia is a mental illness with disturbances in
thinking, feeling and behavior.
OLANZAPINE RBX alone, or in combination with lithium or valproate, is
also used for the short-term treatment of acute manic episodes
associated with bipolar I disorder, an illness where the patient
experiences episodes of overactivity, elation or irritability.
OLANZAPINE RBX is also a mood stabiliser that prevents further
occurrences of the disabling high and low (depressed) extremes of mood
associated with bipolar I disorder.
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.
Y

Summary of Product characteristics

OLANZAPINE RBX PI V8 April 2020 Page 1 of 24
AUSTRALIAN PRODUCT INFORMATION -
OLANZAPINE RBX (OLANZAPINE) TABLETS
1.
NAME OF THE MEDICINE
_ _
_Olanzapine _
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
OLANZAPINE RBX 2.5 mg uncoated tablet contains olanzapine 2.5 mg.
Excipient with known effects: Each 2.5 mg tablet contains 65.5 mg
lactose.
OLANZAPINE RBX 5 mg uncoated tablet contains olanzapine 5 mg.
Excipient with known effects: Each 5 mg tablet contains 131 mg
lactose.
OLANZAPINE RBX 7.5 mg uncoated tablet contains olanzapine 7.5 mg.
Excipient with known effects: Each 7.5 mg tablet contains 196.5 mg
lactose.
OLANZAPINE RBX 10 mg uncoated tablet contains olanzapine 10 mg.
Excipient with known effects: Each 10 mg tablet contains 262 mg
lactose.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Tablet.
OLANZAPINE RBX 2.5 mg uncoated tablets are available as light yellow
to yellow,
round, biconvex tablets debossed with ‘O4’ on one side and plain
on the other side.
OLANZAPINE RBX 5 mg uncoated tablets are available as light yellow to
yellow,
round, biconvex tablets debossed with ‘O5’ on one side and plain
on the other side.
OLANZAPINE RBX 7.5 mg uncoated tablets are available as light yellow
to yellow,
round, biconvex tablets debossed with ‘O6’ on one side and plain
on the other side.
OLANZAPINE RBX 10 mg uncoated tablets are available as light yellow to
yellow,
round, biconvex tablets debossed with ‘O7’ on one side and plain
on the other side.
4.
CLINICAL PARTICULARS
OLANZAPINE RBX PI V8 April 2020 Page 2 of 24
4.1
THERAPEUTIC INDICATIONS
OLANZAPINE RBX 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
Schizophrenia and related disorders:
The recommended starting dose for