OLANZAPINE SANDOZ ODT 20 olanzapine 20mg orally disintegrating 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:
Sandoz Pty Ltd
INN (International Name):
Olanzapine
Pharmaceutical form:
Tablet, orally disintegrating
Composition:
Excipient Ingredients: colloidal anhydrous silica; crospovidone; hyprolose; lactose monohydrate; purified talc; magnesium stearate; Flavour
Administration route:
Oral
Units in package:
10, 50, 20, 28, 14, 21, 60, 30, 7, 40
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: Yellow, round flat tablets; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 18 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure
Authorization status:
Licence status A
Authorization date:
2011-08-12
Patient Information leaflet
OLANZAPINE SANDOZ
®
ODT
1
OLANZAPINE
SANDOZ
® ODT
_olanzapine orally dispersible 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 THIS
MEDICINE.
You may need to read it again.
WHAT OLANZAPINE
SANDOZ ODT IS USED
FOR
OLANZAPINE SANDOZ ODT
belongs to a group of medicines
called antipsychotics. It helps to
correct chemical imbalances in the
brain, which may cause mental
illness.
OLANZAPINE SANDOZ ODT is
used to treat symptoms of
schizophrenia and related psychoses.
OLANZAPINE SANDOZ ODT
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 SANDOZ ODT 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.
Your doctor may have prescribed
OLANZAPINE SANDOZ ODT for
another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY
OLANZAPINE SANDOZ ODT
HAS BEEN PRESCRIBED FOR YOU.
This medicine is available only with
a doctor's prescription.
OLANZAPINE SANDOZ ODT is
not recommended for use in
Read the complete document
Summary of Product characteristics
191219-olanzapine-sandoz-odt-pi
Page 1 of 23
AUSTRALIAN PRODUCT INFORMATION
OLANZAPINE SANDOZ
® ODT (OLANZAPINE) ORALLY DISINTEGRATING
TABLETS
1.
NAME OF THE MEDICINE
Olanzapine
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Olanzapine Sandoz
®
ODT 5 contains 5 mg olanzapine.
Each Olanzapine Sandoz
®
ODT 10 contains 10 mg olanzapine.
Each Olanzapine Sandoz
®
ODT 15 contains 15 mg olanzapine.
Each Olanzapine Sandoz
®
ODT 20 contains 20 mg olanzapine
_Excipient with known effect:_
Lactose monohydrate.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Olanzapine Sandoz
®
ODT are for oral administration only.
Olanzapine Sandoz
®
ODT 5 are yellow, round, biconvex orally disintegrating tablets.
Olanzapine Sandoz
®
ODT 10 are yellow, round, flat orally disintegrating tablets.
Olanzapine Sandoz
®
ODT 15 are yellow, round, biconvex orally disintegrating tablets.
Olanzapine Sandoz
®
ODT 20 are yellow, round, flat orally disintegrating tablets.
4.
CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC INDICATIONS
For the treatment of schizophrenia and related psychoses.
For the short term treatment of acute manic episodes associated with
Bipolar I Disorder, when
used alone or in combination with lithium or valproate.
For preventing recurrence of manic, mixed or depressive episodes in
Bipolar I Disorder.
4.2.
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
_SCHIZOPHRENIA AND RELATED DISORDERS _
The recommended starting dose for olanzapine is 5-10 mg/day,
administered as a single daily
dose without regard to meals. Daily dosage may subsequently be
adjusted on the basis of
individual clinical status within the range of 5-20 mg daily. An
increase to a dose greater than
the routine therapeutic dose of 10 mg/day is recommended only after
appropriate clinical
reassessment.
191219-olanzapine-sandoz-odt-pi
Page 2 of 23
_ACUTE MANIA ASSOCIATED WITH BIPOLAR DISORDER _
The recommended starting dose for olanzapine is 10 or 15 mg
administered once a day as
monotherapy or 10 mg administered once daily in co
Read the complete document
