CHEMMART OLANZAPINE olanzapine 7.5 mg film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

olanzapine

Available from:

Apotex Pty Ltd

INN (International Name):

Olanzapine

Authorization status:

Registered

Patient Information leaflet

CHEMMART OLANZAPINE
FILM COATED TABLETS
_Olanzapine_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about olanzapine.
It does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
The information in this leaflet was
last updated on the date listed on the
last page. More recent information on
this medicine may be available.
ASK YOUR DOCTOR OR PHARMACIST:
•
if there is anything you do not
understand in this leaflet,
•
if you are worried about taking
your medicine, or
•
to obtain the most up-to-date
information.
You can also download the most up
to date leaflet from
www.apotex.com.au
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
Pharmaceutical companies cannot
give you medical advice or an
individual diagnosis.
Keep this leaflet with your medicine.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is
Chemmart Olanzapine. It contains
the active ingredient olanzapine.
It is used:
•
to treat symptoms of
schizophrenia and related
psychoses
•
alone, or in combination with
lithium or valproate, for the short-
term treatment of acute manic
episodes associated with Bipolar I
Disorder.
•
as a mood stabiliser that prevents
further occurrences of 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.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed this
medicine for another reason.
This medicine is availab

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION –
CHEMMART OLANZAPINE FILM COATED TABLETS (OLANZAPINE)
1
NAME OF THE MEDICINE
Olanzapine
2
AND 3 QUALITATIVE AND QUANTITATIVE COMPOSITION AND
PHARMACEUTICAL FORM
Olanzapine is a yellow crystalline solid that is practically insoluble
in water.
Each film coated tablet contains 2.5mg, 5mg, 7.5mg, 10mg, 15mg or 20mg
olanzapine, as the
active ingredient.
In addition, each film coated tablet contains the following inactive
ingredients: lactose
monohydrate, microcrystalline cellulose, maize starch, magnesium
stearate, hypromellose,
hyprolose, macrogol 8000, titanium dioxide, indigo carmine aluminium
lake (15mg only), iron
oxide red (20mg only) and iron oxide yellow (20mg only).
Olanzapine film coated tablets contain lactose
2.5MG FILM COATED TABLETS:
White, round, biconvex film-coated tablet. Engraved “APO” on one
side, “OLA” over “2.5” on
the other side.
5MG FILM COATED TABLETS:
White, round, biconvex film-coated tablet. Engraved “APO” on one
side, “OLA” over “5” on
the other side.
7.5MG FILM COATED TABLETS:
White, round, biconvex film-coated tablet. Engraved “APO” on one
side, “OLA” over “7.5” on
the other side.
10MG FILM COATED TABLETS:
White, round, biconvex film-coated tablet. Engraved “APO” on one
side, “OLA” over “10” on
the other side.
15MG FILM COATED TABLETS:
Light blue, elliptical, biconvex film-coated tablet. Engraved
“APO” on one side, “OLA 15” on
the other side.
20MG FILM COATED TABLETS:
Light pink, elliptical, biconvex film-coated tablet. Engraved
“APO” on one side, “OLA 20” on
the other side.
2
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
Treatment of schizophrenia and related psychoses;
•
Short-term treatment, alone or in combination with lithium or
valproate, of acute manic
episodes associated with bipolar I disorder;
•
Preventing recurrence of manic, mixed or depressive episodes in
Bipolar I Disorder.
4.2
DOSE AND METHOD OF ADMINISTRATION
SCHIZOPHRENIA AND RELATED DISORDERS
The recommended