OLANZAPINE AN olanzapine 20mg 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)
28-11-2017
Active ingredient:
olanzapine, Quantity: 20 mg
Available from:
Amneal Pharma Australia Pty Ltd
INN (International Name):
Olanzapine
Pharmaceutical form:
Tablet, film coated
Composition:
Excipient Ingredients: crospovidone; magnesium stearate; lactose monohydrate; purified talc; microcrystalline cellulose; hyprolose; titanium dioxide; xanthan gum; polyvinyl alcohol; lecithin; iron oxide yellow; iron oxide red; iron oxide black
Administration route:
Oral
Units in package:
7, 40, 10, 28, 60, 30, 50, 20, 14, 21
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
For the treatment of schizophrenia and related psychoses. ,Alone or in combination with lithium or valproate, it is indicated for the short-term treatment of acute manic episodes associated with Bipolar I Disorder. ,For preventing recurrence of manic, mixed or depressive episodes in Bipolar I Disorder.
Product summary:
Visual Identification: Pink, oblong, biconvex, film coated tablets; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius
Authorization status:
Licence status A
Authorization date:
2011-08-11
Patient Information leaflet
_Olanzapine AN and Olanzapine AN ODT tablets – Consumer Medicine
Information _
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_Olanzapine AN and ODT CMI v2.0 _
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_Page 1 _
OLANZAPINE AN AND OLANZAPINE AN ODT TABLETS
_Olanzapine film coated and orally disintegrating 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
to your doctor.
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
your
medicine.
You may need to read it again.
WHAT OLANZAPINE AN
IS USED FOR
Olanzapine AN is used to treat
symptoms of schizophrenia and
related
psychoses.
Olanzapine
AN 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 AN is also a mood
stabiliser
that
prevents
further
occurrences of the disabling high
and low (depressed) extremes of
mood associated with Bipolar I
Disorder.
Schizophrenia is a mental illness
with
disturbances
in
thinking,
feelings and behaviour. 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.
Olanzapine
AN
belongs
to
a
group
of
medicines
called
antipsychotics. It helps to correct
chemical
imbalances
in
the
brain, which may cause mental
illness.
Your
doctor
may
have
prescribed
Olanzapine
AN
for
another reason.
Ask your doctor if you have any
questions about why Olanzapine
AN has been prescribed for you.
This medicine is avail
Read the complete document
Summary of Product characteristics
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_Olanzapine AN and AN ODT tablets Product Information _
_ Amneal Pharma Australia Pty Ltd _
Doc ID: 81.82.AN.P.2.0
Page 1
OLANZAPINE AN AND OLANZAPINE AN ODT
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_(OLANZAPINE TABLETS AND OLANZAPINE ORALLY DISINTEGRATING TABLES) _
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PRODUCT INFORMATION
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NAME OF THE MEDICINE
The name of the medicine is olanzapine.
CHEMICAL NAME:
2-methyl-4-(4-methyl-1-piperazinyl)-10
_H_
-thieno[2,3-
_b_
] [1,5]benzodiazepine
MOLECULAR FORMULA:
C
17
H
20
N
4
S
MOLECULAR WEIGHT:
321.44
CAS REGISTRY NUMBER:
_[132539-06-1] _
DESCRIPTION
Olanzapine is a yellow crystalline solid, practically insoluble in
water
OLANZAPINE AN film coated tablets:
OLANZAPINE AN tablets are film coated tablets for oral administration.
The active ingredient is
olanzapine.
The
inactive
ingredients
are:
lactose,
hydroxypropylcellulose,
crospovidone,
microcrystalline cellulose, magnesium stearate and purified talc.
The film coatings used are as follows:
Opadry AMB complete film coating system OY-B-28920 White (ARPING 4271)
consisting of;
part hydrolysed polyvinyl alcohol, titanium dioxide, purified talc,
lecithin (soya), xanthan gum –
all strengths
Opadry AMB aqueous moisture barrier coating system 80W26503 Grey
(ARPING 107459)
consisting of; part hydrolysed polyvinyl alcohol, titanium dioxide,
purified talc, lecithin (soya),
Indigo carmine aluminium lake, iron oxide yellow, xanthan gum, iron
oxide black – 15mg only
Opadry AMB aqueous moisture barrier coating system 80W24003 Pink
(ARPING 107460)
consisting of; part hydrolysed polyvinyl alcohol, titanium dioxide,
purified talc, lecithin (soya),
iron oxide red, xanthan gum, iron oxide yellow, iron oxide black –
20mg only
OLANZAPINE AN ODT orally disintegrating tablets:
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_Olanzapine AN and AN ODT tablets Product Information _
_ Amneal Pharma Australia Pty Ltd _
Doc ID: 81.82.AN.P.2.0
Page 2
OLANZAPINE
A N
ODT
are
orally
disintegrating
tablets
for
oral
administration.
The
active
ingredient is olanzapine. The inactive ingredients are: lactose,
hydroxypropylcellulose,
crospovidone,
m
Read the complete document
