CLOZARIL clozapine 100 mg tablet blister pack

Riik: Austraalia

keel: inglise

Allikas: Department of Health (Therapeutic Goods Administration)

Toimeaine:

clozapine, Quantity: 100 mg

Saadav alates:

Viatris Pty Ltd

Ravimvorm:

Tablet, uncoated

Koostis:

Excipient Ingredients: lactose monohydrate; colloidal anhydrous silica; maize starch; purified talc; magnesium stearate; povidone

Manustamisviis:

Oral

Ühikuid pakis:

50 x 100mg tablets, 100 x 100 mg tablets, 28 tablets

Retsepti tüüp:

(S4) Prescription Only Medicine

Näidustused:

Clozaril is indicated in treatment-resistant schizophrenic patients only, i.e. schizophrenic patients who are non-responsive to, or intolerant of other antipsychotic drugs. Non-responsiveness is defined as a 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 reactions (extrapyramidal side effects or tardive dyskinesia).

Toote kokkuvõte:

Visual Identification: Circular, flat, yellow, bevelled edged tablet. Approximately 10 mm diameter, coded "CLOZ" on,one side and "Z/A" and angle score on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 5 Years; Container Temperature: Store below 30 degrees Celsius

Volitamisolek:

Registered

Loa andmise kuupäev:

1994-11-21

Infovoldik

CLOZARIL
®
_clozapine_
CONSUMER MEDICINE INFORMATION
GASTROINTESTINAL HYPOMOTILITY (REDUCED GASTROINTESTINAL MOVEMENT) DUE
TO CLOZAPINE
Clozaril may cause slowing down or blockage of intestine function,
resulting in reactions such as constipation; nausea with
or without vomiting; tenderness or swelling of the abdomen, or
bloating; stomach pains/spasms; leakage of diarrhoea or
frequent and forceful bowel movements; bowel urges with no resulting
movements; pain or pressure in the rectum and in-
flammation and bleeding of the bowels from the rectum. These can lead
to severe outcomes. Your doctor must monitor
bowel function before prescribing and during your therapy with
Clozaril. It is extremely important to immediately advise
your doctor, coordinator, pharmacist or any other healthcare
professional, of any changes to your stool/bowel movements.
MYOCARDITIS
CLOZARIL may cause myocarditis (inflammation of heart muscle), which
may be fatal, or another heart condition. Your
doctor will monitor you during treatment. If required, your doctor may
want to refer you to a cardiologist for further tests.
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about CLOZARIL.
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. YOU
CAN ALSO DOWNLOAD THE MOST UP TO
DATE LEAFLET FROM
WWW.MYLAN.COM.AU
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 CLOZARIL
against the benefits they expect it
will provide.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read i

Toote omadused

AUSTRALIAN PRODUCT INFORMATION
CLOZARIL
_Clozapine tablets _
WARNING
_Clozapine induced gastrointestinal hypomotility _
Clozapine induced gastrointestinal hypomotility: Severe
gastrointestinal adverse reactions have
occurred with the use of clozapine resulting in potential outcomes of
hospitalisation, surgery and
death (see Section 4.4 Special warnings and precautions for use, and
Section 4.8 Adverse effects
(undesirable effects)). Prior to initiating and during treatment with
CLOZARIL, screen for
constipation and if necessary, manage as per current clinical
guidelines.
_ _
_Myocarditis _
Cases of myocarditis, some of which have been fatal, and
cardiomyopathy have been reported in
patients on clozapine (see "4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR
USE" and "4.8
ADVERSE
EFFECTS
(UNDESIRABLE
EFFECTS)").
If
myocarditis
or
cardiomyopathy
is
suspected,
Clozaril
treatment
should
be
stopped
and
the
patient
immediately
referred
to
a
cardiologist.
Generally,
patients
with
a
history
of
clozapine-associated
myocarditis
or
cardiomyopathy should not be rechallenged with Clozaril.
1
NAME OF THE MEDICINE
Clozapine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Clozaril tablet contains clozapine 25 mg or 100 mg of the active
ingredient, clozapine.
Excipients with known effect: sugars as lactose.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Tablets, uncoated.
25 mg tablet: Circular, flat, yellow, bevelled edged tablets.
Approximately 6.3 mm diameter, coded “CLOZ”
on one side, and “L/O” and angle score on the reverse.
100 mg tablet: Circular, flat, yellow, bevelled edged tablets.
Approximately 10 mm diameter, coded “CLOZ”
on one side, and “Z/A” and angle score on the reverse.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment with Clozaril is indicated in treatment-resistant
schizophrenic patients only, i.e. schizophrenic
patients who are non-responsive to, or intolerant of, other
antipsychotic drugs.
NON-RESPONSIVENESS
is defined as lack of satisfactory cli