OLANZACCORD TABLETS 10 mg olanzapine 10 mg film-coated tablet blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
24-08-2020
Summary of Product characteristics
(SPC)
24-08-2020
Public Assessment Report
(PAR)
29-11-2017
Active ingredient:
olanzapine, Quantity: 10 mg
Available from:
Accord Healthcare Pty Ltd
INN (International Name):
Olanzapine
Pharmaceutical form:
Tablet, film coated
Composition:
Excipient Ingredients: hypromellose; crospovidone; microcrystalline cellulose; lactose monohydrate; magnesium stearate; hyprolose; titanium dioxide; polysorbate 80; macrogol 400
Administration route:
Oral
Units in package:
28 Tablets in blister pack, 7 Tablets in blister pack
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
Olanzapine tablets are indicated for the treatment of schizophrenia and related psychoses. ,Olanzapine tablets alone or in combination with lithium or valproate is indicated for the short-term treatment of acute manic episodes associated with Bipolar I Disorder. ,Olanzapine tablets are also indicated for preventing recurrence of manic, mixed or depressive episodes in Bipolar I Disorder.
Product summary:
Visual Identification: White to off white round, biconvex, film-coated tablets debossed with "O3" on one side and plain on the other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Authorization status:
Registered
Authorization date:
2012-03-23
Patient Information leaflet
OLANZACCORD TABLETS
CONSUMER MEDICINE INFORMATION
Version: 2.0
-2013- Page: 1 of 6
OLANZACCORD TABLETS
Olanzapine Tablets
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.
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.
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 OLANZACCORD
TABLETS ARE USED FOR
Olanzaccord Tablets belongs to a
group
of
medicines
called
antipsychotics. It helps to correct
chemical imbalances in the brain,
which may cause mental illness.
Olanzaccord Tablets are used to
treat symptoms of schizophrenia
and
related
psychoses.
Schizophrenia is a mental illness
with
disturbances
in
thinking,
feelings and behaviour.
Olanzaccord Tablets alone, or in
combination
with
lithium
or
valproate, is used for the short-
term
treatment
of
acute
manic
episodes associated with Bipolar
I Disorder. Olanzaccord Tablets
are 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.
_ _
Your
doctor
may
have
prescribed Olanzaccord Tablets
for another reason.
ASK YOUR DOCTOR
Read the complete document
Summary of Product characteristics
Olanzaccord Tablets (Olanzapine Tablets) Version 2.0
-2013- Page: 1 of 22
PRODUCT INFORMATION
OLANZACCORD TABLETS
(OLANZAPINE TABLETS)
NAME OF THE MEDICINE
Olanzapine
Chemically,
olanzapine
is
2-methyl-4-(4-methyl-1-piperazinyl)-10
_H_
-thieno[2,3-
_b_
]
[1,5]benzodiazepine and its empirical formula is C
17
H
20
N
4
S. Olanzapine is a yellow
crystalline solid, practically insoluble in water with a molecular
weight of 312.44. The
CAS number for olanzapine is 132539-06-1.
Structural formula:
DESCRIPTION
Olanzaccord Tablets 2.5 mg are presented as white to off white, round,
biconvex, film-
coated tablets, debossed with “O” on one side and plain on the
other side.
Olanzaccord Tablets 5 mg are presented as white to off white, round,
biconvex, film-
coated tablets, debossed with “O1” on one side and plain on the
other side.
Olanzaccord Tablets 7.5 mg are presented as white to off white, round,
biconvex, film-
coated tablets, debossed with “O2” on one side and plain on the
other side.
Olanzaccord Tablets 10 mg are presented as white to off white, round,
biconvex, film-
coated tablets, debossed with “O3” on one side and plain on the
other side.
Olanzaccord Tablets (Olanzapine Tablets) Version 2.0
-2013- Page: 2 of 22
Olanzaccord Tablets 15 mg are presented as light blue, elliptical,
biconvex, film-coated
tablets debossed with “O4” on one side and plain on the other
side.
The active ingredient in Olanzaccord Tablets is olanzapine.
Olanzaccord Tablets also
contain
excipients:
lactose,
microcrystalline
cellulose,
crospovidone,
hydroxypropyl-
cellulose, magnesium stearate and hypromellose. Olanzaccord Tablets
2.5 mg, 5 mg, 7.5
mg and 10 mg Tablets also contain OPADRY complete film coating system
13B58802
WHITE
(ARTG
No.
12811).
Olanzaccord
Tablets
15
mg
also
contain
OPADRY
complete film coating system 13B80968 Blue (ARTG No. 106174).
PHARMACOLOGY
PHARMACODYNAMICS
Olanzapine is an atypical antipsychotic, antimanic and mood
stabilising agent that
demonstrates a broad pharmacological profile across a number
Read the complete document
