Pharm-Olanzapine olanzapine 5mg film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

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Patient Information leaflet (PIL)

24-08-2020

Summary of Product characteristics (SPC)

31-05-2021

Public Assessment Report (PAR)

27-11-2017

Active ingredient:

olanzapine, Quantity: 5 mg

Available from:

Pharmacor Pty Ltd

INN (International Name):

Olanzapine

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: pectin; mannitol; isopropyl alcohol; hyprolose; purified talc; lactose monohydrate; purified water; triacetin; titanium dioxide; magnesium stearate; propylene glycol; butan-1-ol; strong ammonia solution; iron oxide black; ethanol; Shellac; sulfuric acid

Administration route:

Oral

Units in package:

7's (1 x 7 tablets), 28's blister pack (2 x 14 or 4x7's tablets)

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Olanzapine is indicated for the treatment of schizophrenia and related psychoses.,Olanzapine 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 is indicated for preventing recurrence of manic, mixed or depressive episodes in Bipolar I Disorder.

Product summary:

Visual Identification: White to off white colored, film coated, round shaped, biconvex tablets, imprinted '5' with black ink 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; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2014-12-12

Patient Information leaflet

PHARM-OLANZAPINE
1
PHARM-OLANZAPINE
_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.
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 PHARM-
OLANZAPINE IS USED FOR
Pharm-Olanzapine
belongs
to
a
group
of
medicines
called
antipsychotics.
It
helps
to
correct
chemical
imbalances
in
the
brain,
which may cause mental illness.
Pharm-Olanzapine
is
used
to
treat
symptoms
of
schizophrenia
and
related psychoses. Schizophrenia is a
mental
illness
with
disturbances
in
thinking, feelings and behaviour.
Pharm-Olanzapine
alone,
or
in
combination
with
lithium
or
valproate, is used for the short-term
treatment
of
acute
manic
episodes
associated with Bipolar I Disorder.
Pharm-Olanzapine
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.
Your doctor may have prescribed
Pharm-Olanzapine
for
another
reason.
ASK YOUR DOCTOR IF YOU HAVE ANY

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Summary of Product characteristics

Pharm-Olanzapine (Olanzapine)-Product information Page 1 of 19 PHARM-OLANZAPINE
(olanzapine)
NAME OF THE MEDICINE
Pharm-Olanzapine (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 light yellow to
yellow crystalline powder, soluble in n-propanol, sparingly soluble in
acetonitrile, slightly
soluble in methanol and in dehydrated alcohol, practically insoluble
in water. Freely
soluble in Methylene Chloride with a molecular weight of 312.4. The
CAS number for
olanzapine is 132539-06-1.
Olanzapine has the following structural formula:
DESCRIPTION
Pharm-Olanzapine:
Pharm-Olanzapine 2.5 mg, 5 mg, 7.5 mg and 10 mg are white to off white
colored, film
coated, round shaped, biconvex tablets imprinted with respective
strength with black ink
on one side and plain on other side for oral administration. The
active ingredient in
olanzapine tablets is olanzapine. Olanzapine tablets also contain
excipients: lactose,
hydroxypropylcellulose,
mannitol,
magnesium
stearate,
pectin,
glycerol
triacetate,
titanium dioxide, talc- purified, isopropyl alcohol and Opacode
S-1-17823 black (ARTG #
12108).
Pharm-Olanzapine (Olanzapine)-Product information Page 2 of 19
PHARMACOLOGY
PHARMACODYNAMICS
Olanzapine is an atypical antipsychotic, antimanic and mood
stabilising agent that
demonstrates a broad pharmacological profile across a number of
receptor systems.
In preclinical studies, olanzapine exhibited a range of receptor
affinities (Ki; < 100 nmol)
for serotonin 5HT
2A/2C
, 5HT
3
, 5HT
6
; dopamine D
1
, D
2
, D
3
, D
4
, D
5
; cholinergic muscarinic
receptors m
1
-m
5
; α
1
adrenergic; and histamine H
1
receptors. Animal behavioural studies
with olanzapine indicated 5HT, dopamine and cholinergic antagonism,
consistent with
the receptor binding profile. Olanzapine demonstrated a greater _
in-vitro _ affinity for
serotonin 5HT
2
than dopamine D
2
receptors and in _in-vivo _models, greater 5HT
2
than D
2
activity. El

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