Apo-Olanzapine

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Olanzapine 15mg

Available from:

Apotex NZ Ltd

INN (International Name):

Olanzapine 15 mg

Dosage:

15 mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Olanzapine 15mg Excipient: Hyprolose Hypromellose Indigo carmine Lactose monohydrate Macrogol 8000 Magnesium stearate Maize starch Microcrystalline cellulose Purified water Titanium dioxide

Units in package:

Blister pack, Al/Al blister, 28 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Apotex Pharmachem Inc

Therapeutic indications:

Olanzapine is indicated for the treatment of schizophrenia and related psychoses.

Product summary:

Package - Contents - Shelf Life: Blister pack, Al/Al blister - 28 tablets - 24 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE - 100 tablets - 24 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE - 500 tablets - 24 months from date of manufacture stored at or below 25°C

Authorization date:

2010-03-29

Patient Information leaflet

1
New Zealand Consumer Medicine Information
APO-OLANZAPINE
_OLANZAPINE _
2.5mg, 5mg, 7.5mg 10mg, 15mg and 20mg film coated tablets
and
5mg, 10mg, 15mg and 20mg orally disintegrating tablets
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you start using
Apo-Olanzapine.
This leaflet answers some common questions about Apo-Olanzapine. It
does not
contain all the available information. It does not take the place of
talking to your
doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of you using
Apo-Olanzapine against the benefits they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
Keep this leaflet with the medicine. You may need to read it again.
WHAT APO-OLANZAPINE IS USED FOR
The name of your medicine is Apo-Olanzapine. It contains the active
ingredient
olanzapine.
Olanzapine belongs to a group of medicines called antipsychotics. It
helps to correct
chemical imbalances in the brain, which may cause mental illness.
Apo-Olanzapine is used:
•
to
treat
symptoms
of
schizophrenia
and
related
psychoses.
Schizophrenia is a mental illness with disturbances in thinking,
feelings
and behaviour.
•
alone or in combination with lithium or valproate is indicated for the
short-term treatment of acute manic episodes associated with Bipolar I
Disorder.
•
As a mood stabiliser that prevents further occurrences of the
disabling
high and low (depressed) extremes of mood associated with Bipolar I
Disorder.
2
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 Apo-Olanzapine for another reason.
Ask your doctor if you have any questions about why Apo-Olanzapine has
been
prescribed for you.
This medicine is available only with a doctor's prescription.
Apo-Olanzapine is not recommended for use in children u

Summary of Product characteristics

NEW ZEALAND DATA SHEET
APO-OLANZAPINE
Please refer to Medsafe website (www.medsafe.govt.nz) for the most
recent datasheet Page 1
1. APO-OLANZAPINE
(2.5MG, 5MG, 7.5MG, 10MG, 15MG & 20MG FILM COATED TABLETS) and
APO-OLANZAPINE ODT
(5MG, 10MG, 15MG & 20MG ORALLY DISINTEGRATING TABLETS)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Olanzapine 2.5mg, 5mg, 7.5mg, 10mg, 15mg or 20mg per film coated
tablet or
Olanzapine 5mg, 10mg, 15mg or 20mg per orally disintegrating tablet
EXCIPIENT(S) OF KNOWN EFFECT
APO-OLANZAPINE contains lactose.
APO-OLANZAPINE ODT contains sucralose.
APO-OLANZAPINE and APO-OLANZAPINE ODT do not contain gluten.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
APO-OLANZAPINE 2.5mg film coated tablet: White, round, biconvex
film-coated tablet. Engraved
“APO’ on one side, “OLA” over “2.5” on the other side.
APO-OLANZAPINE 5mg film coated tablet: White, round, biconvex
film-coated tablet. Engraved “APO’
on one side, “OLA” over “5” on the other side.
APO-OLANZAPINE 7.5mg film coated tablet: White, round, biconvex
film-coated tablet. Engraved
“APO’ on one side, “OLA” over “7.5” on the other side.
APO-OLANZAPINE 10mg film coated tablet: White, round, biconvex
film-coated tablet. Engraved
“APO’ on one side, “OLA” over “10” on the other side.
APO-OLANZAPINE
15mg
film
coated
tablet:
Light
blue,
elliptical,
biconvex
film-coated
tablet.
Engraved “APO’ on one side, “OLA 15” on the other side.
APO-OLANZAPINE
20mg
film
coated
tablet:
Light
pink,
elliptical,
biconvex
film-coated
tablet.
Engraved “APO’ on one side, “OLA 20” on the other side.
Film coated tablet cannot be halved.
APO-OLANZAPINE ODT 5mg orally disintegrating tablet: Yellow, round,
flat faced radial edge tablet.
Engraved “APO’ on one side, “OL” over “5” on the other
side.
APO-OLANZAPINE ODT 10mg orally disintegrating tablet: Yellow, round,
flat faced radial edge tablet.
Engraved “APO’ on one side, “OL” over “10” on the other
side.
APO-OLANZAPIN