ZYPREXA olanzapine 2.5mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

olanzapine, Quantity: 2.5 mg

Available from:

Eli Lilly Australia Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: Carnauba Wax; crospovidone; lactose monohydrate; microcrystalline cellulose; hypromellose; magnesium stearate; hyprolose; propylene glycol; indigo carmine; butan-1-ol; ethanol; isopropyl alcohol; Shellac; strong ammonia solution; Colour

Administration route:

Oral

Units in package:

7 tablets, 28 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Zyprexa is indicated for the treatment of schizophrenia and related psychoses. Zyprexa alone or in combination with lithium or valproate is indicated for the short-term treatment of acute manic episodes associated with Bipolar I Disorder. Zyprexa is indicated for preventing recurrence of manic, mixed or depressive episodes in Bipolar I Disorder.

Product summary:

Visual Identification: round, white, film coated tablet that are imprinted in a single side with "Lilly" and identicode "4112"; Container Type: Blister Pack; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

1997-03-05

Patient Information leaflet

ZYPREXA
® AND
ZYPREXA
®
ZYDIS
®
_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. You can also download the
most up to date leaflet from
www.lilly.com.au . The updated
leaflet may contain important
information about ZYPREXA 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 ZYPREXA IS
USED FOR
ZYPREXA belongs to a group of
medicines called antipsychotics. It
helps to correct chemical imbalances
in the brain, which may cause mental
illness.
ZYPREXA is used to treat symptoms
of schizophrenia and related
psychoses. Schizophrenia is a mental
illness with disturbances in thinking,
feelings and behaviour.
ZYPREXA alone, or in combination
with lithium or valproate, is used for
the short-term treatment of acute
manic episodes associated with
Bipolar I Disorder. ZYPREXA 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

Summary of Product characteristics

vA18_Sept2019
Supercedes: vA17-0_10Oct2018
Page 1 of 23
AUSTRALIAN PRODUCT INFORMATION
ZYPREXA (OLANZAPINE)
1.
NAME OF THE MEDICINE
ZYPREXA
®
(olanzapine)
ZYPREXA ZYDIS
®
(olanzapine)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Olanzapine 2.5 mg, 5 mg, 7.5 mg and 10 mg tablets.
Olanzapine 5 mg and 10 mg wafers.
The active ingredient in ZYPREXA tablets is olanzapine. ZYPREXA
tablets also contain
excipients: lactose monohydrate, hyprolose, crospovidone,
microcrystalline cellulose,
magnesium stearate, hypromellose and carnauba wax. ZYPREXA 2.5 mg, 5
mg, 7.5 mg and
10 mg tablets also contain Colour Mixture White YS-1-18027-A, OPACODE
BLUE S-1-10537G
and Edible Blue Ink. ZYPREXA 15 mg tablets also contain Opadry II
Aqueous Film Coating
Y-30-10671-A Light Blue. ZYPREXA 20 mg tablets also contain Opadry II
Aqueous Film
Coating Y-30-14631-A Pink.
The active ingredient in ZYPREXA ZYDIS wafers is olanzapine. ZYPREXA
ZYDIS wafers also
contain excipients: gelatin, mannitol, aspartame (which is a source of
phenylalanine), sodium
methyl hydroxybenzoate and sodium propyl hydroxybenzoate.
3.
PHARMACEUTICAL FORM
ZYPREXA TABLETS
ZYPREXA tablets are white, film-coated tablets.
Zyprexa 2 mg tablet: round, white, film-coated tablet that is
imprinted in a single side with
"Lilly" and identicode "4112".
Zyprexa 5 mg tablet: round, white, film-coated tablet that is
inprinted on a single side with
"Lilly" and identicode "4115".
Zyprexa 7.5 mg tablet: round, white, film-coated tablet that is
inprinted on a single side with
"Lilly" and identicode "4116".
Zyprexa 10 mg tablet: round, white, film-coated tablet that is
imprinted on a single side with
"Lilly" and identicode "4117".
Zyprexa 15 mg tablet: elliptical, blue, film-coated tablet, debossed
with 'LILLY' and '4415'.
Zyprexa 20 mg tablet: elliptical, pink, film coated tablet, debossed
with 'LILLY' and '4420'.
vA18_Sept2019
Supercedes: vA17-0_10Oct2018
Page 2 of 23
ZYPREXA ZYDIS WAFERS
ZYPREXA ZYDIS wafers are a freeze-dried, rapid dispersing preparation.
ZYPREXA ZYDIS
wafers are yello