PRYZEX olanzapine 7.5 mg film coated tablet blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
27-10-2020
Summary of Product characteristics
(SPC)
27-10-2020
Public Assessment Report
(PAR)
28-11-2017
Active ingredient:
olanzapine, Quantity: 7.5 mg
Available from:
Arrotex Pharmaceuticals Pty Ltd
INN (International Name):
Olanzapine
Pharmaceutical form:
Tablet, film coated
Composition:
Excipient Ingredients: hyprolose; purified talc; magnesium stearate; lactose monohydrate; crospovidone; microcrystalline cellulose; titanium dioxide; xanthan gum; polyvinyl alcohol; lecithin
Administration route:
Oral
Units in package:
21, 40, 60, 50, 28, 14, 20, 7, 30, 10
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: White, round, biconvex film coated tablets; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius
Authorization status:
Registered
Authorization date:
2011-08-11
Patient Information leaflet
_PRYZEX ODT – Consumer Medicine Information _
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_PRYZEX ODT CMI _
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_Page 1 _
PRYZEX ODT
_Olanzapine orally disintegrating 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
YOUR
MEDICINE.
You may need to read it again.
WHAT PRYZEX IS USED
FOR
PRYZEX belongs to a group of
medicines called antipsychotics.
It
helps
to
correct
chemical
imbalances in the brain, which
may cause mental illness.
PRYZEX
is
used
to
treat
symptoms of schizophrenia and
related psychoses.
Schizophrenia is a mental illness
with
disturbances
in
thinking,
feelings and behaviour.
PRYZEX
alone,
or
in
combination
with
lithium
or
valproate, is used for the short-
term treatment of acute manic
episodes associated with Bipolar
I Disorder.
PRYZEX
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
sometimes
severe
irritability.
Your
doctor
may
have
prescribed PRYZEX for another
reason.
ASK YOUR DOCTOR IF YOU HAVE
ANY
QUESTIONS
ABOUT
WHY
PRYZEX HAS BEEN PRESCRIBED
FOR YOU.
This medicine is available only
with a doctor's prescription.
PRYZEX
is
not
recommended
for use in children under the age
of
18
years
as
there
is
not
enough information
Read the complete document
Summary of Product characteristics
1
AUSTRALIAN PRODUCT INFORMATION –
PRYZEX ODT (OLANZAPINE) ORALLY DISINTEGRATING TABLETS
1
NAME OF THE MEDICINE
Olanzapine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
PRYZEX ODT orally disintegrating tablets contain olanzapine 5 mg, 10
mg, 15 mg and 20 mg.
Excipients with known effect: sugars as lactose monohydrate.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
PRYZEX ODT 5 mg: Yellow, round, biconvex orally disintegrating
tablets.
PRYZEX ODT 10 mg: Yellow, round, flat orally disintegrating tablets.
PRYZEX ODT 15 mg: Yellow, round, biconvex orally disintegrating
tablets.
PRYZEX ODT 20 mg: 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.
2
4.2
D
OSE AND METHOD OF ADMINISTRATION
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.
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 combination therapy
with lithium or valproate. It
may be given without regard to meals. Dosage adjustments, if
indicated, should generally occur at
intervals of not less than 24 hours. When dosage adjustments are
necessary, dose
increments/decrements of 5 mg daily are recommended. Antimanic
efficacy was demonstrated in a
dose range of 5 mg to 20 mg/day in clinical tri
Read the complete document
