LANZEK olanzapine 7.5mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

olanzapine

Available from:

Eli Lilly Australia Pty Ltd

INN (International Name):

Olanzapine

Authorization status:

Registered

Patient Information leaflet

LANZEK
® AND
LANZEK
®
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 LANZEK 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 LANZEK IS USED
FOR
LANZEK belongs to a group of
medicines called antipsychotics. It
helps to correct chemical imbalances
in the brain, which may cause mental
illness.
LANZEK is used to treat symptoms
of schizophrenia and related
psychoses. Schizophrenia is a mental
illness with disturbances in thinking,
feelings and behaviour.
LANZEK alone, or in combination
with lithium or valproate, is used for
the short-term treatment of acute
manic episodes associated with
Bipolar I Disorder. LANZEK 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 som

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
vA7.0_10Oct2018
Supersedes: vD6-4_27Aug2018
Page 1 of 22
LANZEK AND LANZEK ZYDIS (OLANZAPINE)
1.
NAME OF THE MEDICINE
LANZEK
®
(olanzapine)
LANZEK 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 LANZEK tablets is olanzapine. LANZEK tablets
also contain
excipients: lactose monohydrate, hyprolose, crospovidone,
microcrystalline cellulose,
magnesium stearate, hypromellose and carnauba wax. LANZEK 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.
The active ingredient in LANZEK ZYDIS wafers is olanzapine. LANZEK
ZYDIS wafers also
contain excipients: gelatin, mannitol, aspartame (which is a source of
phenylalanine), sodium
methyl hydroxybenzoate and sodium propyl hydroxybenzoate.
3.
PHARMACEUTICAL FORM
LANZEK
LANZEK tablets are white, round, film coated tablets that are
imprinted on one side with
‘Lilly’ and on the other side with the product code shown below
for each strength.
LANZEK 2.5 mg tablet: round, white, film-coated tablet that is
imprinted in a single side with
"Lilly" and identicode "4112".
LANZEK 5 mg tablet: round, white, film-coated tablet that is imprinted
on a single side with
"Lilly" and identicode "4115".
LANZEK 7.5 mg tablet: round. white, film-coated tablet that is
inprinted on a single side with
"Lilly" and identicode"4116".
LANZEK 10 mg tablet: round, white, film-coated tablet that is
imprinted on a single side with
"Lilly" and identicode "4117".
LANZEK ZYDIS
LANZEK ZYDIS wafers are a freeze dried, rapid-dispersing preparation.
LANZEK ZYDIS
wafers are yellow, round wafers with no markings.
vA7.0_10Oct2018
Supersedes: vD6-4_27Aug2018
Page 2 of 22
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
LANZEK is indicated for the treatment of schizophrenia and related
psychoses.
LANZEK alone or in combination with lithium or valproate is indicated
for the short