OLANZAPINE-DRLA olanzapine 5mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

olanzapine, Quantity: 5 mg

Available from:

Dr Reddys Laboratories Australia Pty Ltd

INN (International Name):

Olanzapine

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: lactose monohydrate; microcrystalline cellulose; crospovidone; magnesium stearate; hyprolose; titanium dioxide; hypromellose; macrogol 400

Administration route:

Oral

Units in package:

28 tablet

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 to off-white, film coated, oval, biconvex tablets, debossed "OLZ" on one side and "5" on the other side; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2011-02-17

Patient Information leaflet

OLANZAPINE-DRLA
_Olanzapine _
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet is designed
to provide you with
answers to some
common questions
about this medicine. It
does not contain all the
available information
and does not take the
place of talking with
your doctor.
The information in this
leaflet was last updated
on the date shown on
the final page. More
recent information about
this medicine may be
available. Make sure
you speak to your
pharmacist or doctor to
obtain the most up to
date information on this
medicine. The updated
leaflet may contain
important information
about Olanzapine-
DRLA and its use that
you should be aware of.
All medicines have risks
and benefits.
Your doctor has more
information about this
medicine than is
contained in this leaflet.
Also, your doctor has
had the benefit of taking
a full and detailed
history from you and is
in the best position to
make an expert
judgement to meet your
individual needs.
IF YOU HAVE ANY
CONCERNS ABOUT TAKING
THIS MEDICINE, TALK TO
YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH
THIS MEDICINE.
You may need to read it
again.
WHAT
OLANZAPINE-
DRLA IS USED FOR
Olanzapine-DRLA
belongs to a group of
medicines called
antipsychotics. It helps
to correct chemical
imbalances in the brain,
which may cause mental
illness.
Olanzapine-DRLA is
used to treat symptoms
of schizophrenia and
related psychoses.
Schizophrenia is a
mental illness with
disturbances in thinking,
feelings and behaviour.
Olanzapine-DRLA
alone, or in combination
with lithium or valproate,
is used for the short-
term treatment of acute
manic episodes
associated with Bipolar
I Disorder. Olanzapine-
DRLA 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.

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – OLANZAPINE-DRLA
(OLANZAPINE) TABLETS
1
NAME OF THE MEDICINE
Olanzapine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Olanzapine 2.5 mg, 5 mg, 7.5 mg and 10 mg tablets.
The active ingredient in OLANZAPINE-DRLA tablets is olanzapine.
OLANZAPINE-DRLA tablets
also contain excipients: Lactose monohydrate, –microcrystalline
cellulose, crospovidone,
hyprolose,
magnesium stearate, Opadry complete film coating system OY-58900
WHITE(2.5
mg
tablets) PI no.3446 , Opadry complete film coating system 06B580002
WHITE (5 mg, 7.5
mg and 10 mg tablets) PI no. 107258.
3
PHARMACEUTICAL FORM
OLANZAPINE-DRLA TABLETS
2.5 mg tablet: White to off-white, film coated, oval, biconvex
tablets, debossed “OLZ” on
one
side and “2.5” on other side.
5 mg tablet: White to off-white, film coated, oval, biconvex tablets,
debossed “OLZ” on
one side
and “5” on other side.
7.5 mg tablet: White to off-white, film coated, oval, biconvex
tablets, debossed “OLZ” on
one
side and “7.5” on other side.
10 mg tablet: White to off-white, film coated, oval, biconvex tablets,
debossed “OLZ” on
one
side and “10” on other side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
•
Treatment of schizophrenia and related psychoses.
•
Alone or in combination with lithium or valproate is indicated for
short-term
treatment, of acute manic episodes associated with bipolar I disorder.
•
Preventing recurrence of manic, mixed or depressive episodes in
bipolar I
disorder.
4.2
D
OSE AND METHOD OF ADMINISTRATION
SCHIZOPHRENIA AND RELATED DISORDERS.
The recommended starting dose for
Olanzapine-DRLA is 5 to 10 mg/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 20 mg daily. An
increase to a dose greater than
1
the routine
therapeutic dose of 10 mg/day is recommended only after appropriate
clinical
reassessment.
ACUTE MANIA ASSOCIATED WITH BIPOLAR DISORDER.
The recommended starting dos