Clozaril

País: Nueva Zelanda

Idioma: inglés

Fuente: Medsafe (Medicines Safety Authority)

Ingredientes activos:

Clozapine 100mg;  ;  ;  

Disponible desde:

Viatris Limited

Designación común internacional (DCI):

Clozapine 100 mg

Dosis:

100 mg

formulario farmacéutico:

Tablet

Composición:

Active: Clozapine 100mg       Excipient: Colloidal silicon dioxide Lactose monohydrate Magnesium stearate Maize starch Povidone Purified talc Purified water

Unidades en paquete:

Blister pack, Al foil/PVC/PE/PVdC, 50 tablets

clase:

Prescription

tipo de receta:

Prescription

Fabricado por:

Arevipharma GmbH

indicaciones terapéuticas:

Clozaril is indicated in patients with treatment-resistant schizophrenia, i.e. patients with schizophrenia who are non-responsive to or intolerant of classic antipsychotics. Non-responsiveness is defined as a lack of satisfactory clinical improvement despite the use of adequate doses of at least two marketed antipsychotics prescribed for adequate durations. Intolerance is defined as the impossibility of achieving adequate clinical benefit with classic antipsychotics because of severe and untreatable neurological adverse reactions (extrapyramidal side effects or tardive dyskinesia).

Resumen del producto:

Package - Contents - Shelf Life: Blister pack, Al foil/PVC/PE/PVdC - 50 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, Al foil/PVC/PVdC - 50 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, Al foil/PVC/PE/PVdC - 100 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, Al foil/PVC/PVdC - 100 tablets - 36 months from date of manufacture stored at or below 30°C - Bottle, glass, amber, tamper evident closure - 100 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE white with PP CRC - 100 tablets - 36 months from date of manufacture stored at or below 25°C

Fecha de autorización:

1993-02-03

Información para el usuario

Page 1 of 7
NEW ZEALAND CONSUMER MEDICINE INFORMATION
CLOZARIL
®
_CLOZAPINE TABLETS 25 MG AND 100 MG_
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start taking Clozaril
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.MEDSAFE.GOVT.NZ
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 it
again.
WHAT CLOZARIL IS
USED FOR
Clozaril is used to treat
schizophrenia, which is a mental
illness involving disturbances in
thinking, feelings and behaviour. It
helps to correct chemical
imbalances in the brain which may
cause mental illness.
Clozaril is only used to treat patients
suffering with schizophrenia when
other antipsychotic medicines either
have not worked or have caused
severe side effects.
This medicine contains an active
ingredient called clozapine. Clozaril
tablets belong to a group of
medicines called antipsychotics.
Your doctor may have prescribed it
for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY CLOZARIL HAS
BEEN PRESCRIBED FOR YOU.
Clozaril is available only with a
doctor's prescription.
There is no evidence that it is
addictive.
Clozaril is not recommended for use
in children or adolescents, as there
is not enough information on its use
in that age group.
Clozaril is also n

Ficha técnica

Page 1 of 20
NEW ZEALAND DATA SHEET
CLOZARIL
®
Clozaril
®
can cause agranulocytosis. Its use should be limited to patients:

with schizophrenia who are non-responsive to, or intolerant of,
classical antipsychotic agents, or with
schizophrenia or schizoaffective disorder who are at risk of recurrent
suicidal behaviour (see section
4.1),

who have initially normal leukocyte findings (white blood cell count
(WBC) ≥ 3500/mm
3
(3.5 x 10
9
/L),
and absolute neutrophil counts (ANC) ≥ 2000/mm
3
(2.0 x 10
9
/L)),

and in whom regular white blood cell counts and absolute neutrophil
counts can be performed as
follows: weekly during the first 18 weeks of therapy, and at least
every 4 weeks thereafter throughout
treatment.
Monitoring
must
continue
throughout
treatment
and
for
4
weeks
after
complete
discontinuation of Clozaril
®
(see section 4.4).
Prescribing physicians should comply fully with the required safety
measures. At each consultation, a patient
receiving Clozaril
®
should be reminded to contact the treating physician immediately if
any kind of infection
begins to develop. Particular attention should be paid to flu-like
complaints such as fever or sore throat and to
other evidence of infection, which may be indicative of neutropenia
(see section 4.4.). Close monitoring of
bowel habits is also recommended for any signs of constipation or
gastrointestinal hypomotility.
Clozaril
®
must be prescribed and dispensed in accordance with appropriate local
guidelines. The following
conditions apply to the sale, supply and use of Clozaril
®
in New Zealand under the consent notice from
Medsafe. Mylan New Zealand Ltd draws prescribers, nurses, and
patients’ attention to the following criteria:
Clozapine may only be initiated and prescribed by:

Registered medical practitioners as defined in the Health
Practitioners Competence Assurance Act
2003 who are certified by the Medical Council of New Zealand as
competent in the scope of practice
of psychiatry (i.e. psychiatrist);

Medical practitioners employed