OLANZAPINE SANDOZ olanzapine 5mg film coated tablet, blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

olanzapine, Quantity: 5 mg

Available from:

Sandoz Pty Ltd

INN (International Name):

Olanzapine

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: microcrystalline cellulose; crospovidone; magnesium stearate; hyprolose; lactose monohydrate; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350

Administration route:

Oral

Units in package:

28 tablets

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: White, round, film coated tablet with a breaking notch on one side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2011-04-05

Patient Information leaflet

OLANZAPINE SANDOZ
®
1
OLANZAPINE SANDOZ
®
_olanzapine film-coated tablets _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Olanzapine Sandoz.
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 OLANZAPINE
SANDOZ IS USED FOR
This medicine is used:
•
to treat symptoms of
schizophrenia and related
psychoses. Schizophrenia is a
mental illness with disturbances
in thinking, feelings and
behaviour.
•
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
(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.
It contains the active ingredient
olanzapine.
Olanzapine belongs to a group of
medicines called antipsychotics.
It works by helping 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 it
for another reason.
This medicine is available only with
a doctor's prescription.
Olanzapine is not recommended for
use in children under the age of 18
years as there is not enough
information on its effects in this age
group.
BEFORE YOU TAKE
OLANZAPINE SANDOZ
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
olanza

Summary of Product characteristics

191218-olanzapine-sandoz-pi
Page 1 of 24
AUSTRALIAN PRODUCT INFORMATION
OLANZAPINE SANDOZ
® (OLANZAPINE) FILM-COATED TABLETS
1.
NAME OF THE MEDICINE
Olanzapine
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Olanzapine Sandoz 2.5 mg film-coated tablets contains 2.5 mg
olanzapine.
Each Olanzapine Sandoz 5 mg film-coated tablets contains 5 mg
olanzapine.
Each Olanzapine Sandoz 7.5 mg film-coated tablets contains 7.5 mg
olanzapine.
Each Olanzapine Sandoz 10 mg film-coated tablets contains 10 mg
olanzapine.
Each Olanzapine Sandoz 15 mg film-coated tablets contains 15 mg
olanzapine.
Each Olanzapine Sandoz 20 mg film-coated tablets contains 20 mg
olanzapine.
_Not all strengths may be currently marketed. _
_Excipient with known effect:_
lactose monohydrate.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Olanzapine Sandoz 2.5 mg tablets are white, round, film coated
tablets.
Olanzapine Sandoz 5 mg tablets are white, round, film-coated tablets
with a breaking notch on
one side.
Olanzapine Sandoz 7.5 mg tablets are white, round, film-coated
tablets.
Olanzapine Sandoz 10 mg tablets are white, round, film-coated tablets
with a breaking notch
on one side.
Olanzapine Sandoz 15 mg tablets are light blue, oval, film-coated
tablets with a breaking notch
on both sides.
Olanzapine Sandoz 20 mg tablets are pink, oval, film-coated tablets
with a breaking notch on
both sides.
4.
CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC INDICATIONS
Olanzapine is 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 I disorder.
191218-olanzapine-sandoz-pi
Page 2 of 24
4.2.
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
_SCHIZOPHRENIA AND RELATED DISORDERS _
The recommended starting dose for Olanzapine Sandoz is 5-10 mg/day.
Daily dosage may
subsequently be adjusted on the basis of individual