PHARMACOR CLOZAPINE clozapine 200 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

clozapine, Quantity: 200 mg

Available from:

Pharmacor Pty Ltd

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: sodium starch glycollate type A; povidone; lactose monohydrate; microcrystalline cellulose; magnesium stearate

Administration route:

Oral

Units in package:

100, 50

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment with PHARMACOR CLOZAPINE is indicated only in people with treatment resistant schizophrenia, i.e. people with schizophrenia who are non-responsive to, or intolerant of other antipsychotic drugs.,Non-responsiveness is defined as lack of satisfactory clinical improvement despite the use of adequate doses of at least two classes of marketed antipsychotic drugs prescribed for reasonable durations.,Intolerance is defined as the impossibility to achieve adequate benefit with other antipsychotic drugs because of severe and untreatable neurological adverse effects (extrapyramidal side effects or tardive dyskinesia).

Product summary:

Visual Identification: Oval shaped, yellow tablet with 200 on one side and break line on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2021-09-17

Patient Information leaflet

PHARMACOR CLOZAPINE
_CLOZAPINE _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers
some
common questions about
PHARMACOR CLOZAPINE.
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 final page. More
recent information on the
medicine may be available.
YOU SHOULD ENSURE THAT YOU
SPEAK TO YOUR PHARMACIST OR
DOCTOR TO OBTAIN THE MOST UP
TO DATE INFORMATION ON THE
MEDICINE
.
Those updates may contain
important information about the
medicine and its use of which
you should be aware.
All
medicines
have
risks
and
benefits.
Your
doctor
has
weighed the risks of you taking
PHARMACOR
CLOZAPINE
against the benefits they expect
it will have for you.
IF
YOU
HAVE
ANY
CONCERNS
ABOUT THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP
THIS
LEAFLET
WITH
THE
MEDICINE.
You may need to read it again.
WHAT
PHARMACOR
CLOZAPINE IS USED FOR
PHARMACOR CLOZAPINE is
used
in
patients
with
schizophrenia
for
whom
other
antipsychotic
medicines
have
not
worked
or
have
caused
severe side effects.
This
medicine
belongs
to
the
group
of
medicines
known
as
antipsychotics.
This
group
of
medicines is mainly used in the
treatment
of
schizophrenia.
Schizophrenia
is
a
mental
illness
with
disturbances
in
thinking,
feelings
and
behaviour.
This
medicine
is
thought
to
work by correcting the chemical
imbalances in the brain which
may cause mental illness.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED
FOR YOU.
Your
doctor
may
have
prescribed it for another reason.
There is no evidence that this
medicine is addictive.
This medicine is available only
with a doctor's prescription.
There is not enough information
to recommend the use of this
medicine in children under the
age of 16 years.
BEFORE YOU TAKE
PHARMACOR
CLOZAPINE
_ _
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE PHARMACOR
CLOZAPINE IF YOU HAVE AN
ALLERGY TO:
• any medicine containing
clozapine
•

Summary of Product characteristics

Version No: 01
Page 1
AUSTRALIAN PRODUCT INFORMATION - PHARMACOR CLOZAPINE
(CLOZAPINE)
WARNING
1.
NAME OF THE MEDICINE
Clozapine
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
PHARMACOR CLOZAPINE is available in 4 strength for oral administration
containing
25mg, 50 mg, 100 mg & 200 mg clozapine.
PHARMACOR CLOZAPINE 25 mg: Each tablet contains 25 mg clozapine
PHARMACOR CLOZAPINE 50 mg: Each tablet contains 50 mg clozapine
PHARMACOR CLOZAPINE 100 mg: Each tablet contains 100 mg clozapine
PHARMACOR CLOZAPINE 200 mg: Each tablet contains 200 mg clozapine
Excipients with known effect:
Tablets: Contains Sugars (as lactose monohydrate).
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Tablets, Uncoated
PHARMACOR CLOZAPINE 25 mg-
Round yellow, flat, beveled edge tablets engraved with 25 over a
pressure sensitive break line
on one face, the other face plain.
PHARMACOR CLOZAPINE 50 mg-
Round, yellow, flat, beveled edge tablets engraved with 50 over a
pressure sensitive break line
on one face. The other face plain.
PHARMACOR CLOZAPINE 100 mg-
Round yellow, flat, beveled edge tablets engraved with 100 over a
pressure sensitive break line
on one face. The other face plain.
PHARMACOR CLOZAPINE 200 mg-
Oval shaped, yellow tablets with "200” on one side and break line on
other side.
1.1
_MYOCARDITIS/CARDIOMYOPATHY_: CASES OF MYOCARDITIS, SOME OF WHICH HAVE
BEEN FATAL, AND
CARDIOMYOPATHY HAVE BEEN REPORTED IN PATIENTS ON CLOZAPINE (SEE
SECTION 4.4 SPECIAL
WARNINGS AND PRECAUTIONS FOR USE AND SECTION 4.8 ADVERSE EFFECTS
(UNDESIRABLE
EFFECTS)).
Version No: 01
Page 2
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment with PHARMACOR CLOZAPINE is indicated only in people with
treatment-
resistant schizophrenia, i.e. people with schizophrenia who are
non-responsive to, or intolerant
of other antipsychotic drugs.
_Non-responsiveness _
is defined as lack of satisfactory clinical improvement despite the
use of
adequate
doses
of
at
least
two
classes
of
marketed
antipsychotic
drugs
presc