CLOZARIL 100MG TABLETS

Država: Malezija

Jezik: angleščina

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktivna sestavina:

CLOZAPINE

Dostopno od:

MYLAN HEALTHCARE SDN. BHD.

INN (mednarodno ime):

CLOZAPINE

Enote v paketu:

50Tablet Tablets

Izdeluje:

MADAUS GmBH

Navodilo za uporabo

CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)
CLOZARIL
®
CLOZAPINE 25 MG OR 100 MG TABLETS
1
What is in this leaflet
1.
WHAT CLOZARIL IS USED FOR
2.
HOW CLOZARIL WORKS
3.
BEFORE YOU USE CLOZARIL
4.
HOW TO USE CLOZARIL
5.
WHILE YOU ARE USING
CLOZARIL
6.
SIDE EFFECTS
7.
STORAGE AND DISPOSAL OF
CLOZARIL
8.
PRODUCT DESCRIPTION
9.
MANUFACTURER AND PRODUCT
REGISTRATION HOLDER
10.
DATE OF REVISION
WHAT CLOZARIL IS USED FOR
Clozaril tablets contain an active
substance called clozapine. This
medicine belongs to a group of
medicines called antipsychotics.
Clozaril is used to treat people
suffering from schizophrenia who
have either tried other
antipsychotic medications and did
not benefit sufficiently or who are
unable to tolerate other
antipsychotic medications because
of side effects.
Clozaril is also used to treat
people suffering from
schizophrenia or schizoaffective
disorder (schizophrenia with
mood disorders) who might
otherwise attempt to commit
suicide.
Schizophrenia is a mental illness
involving disturbances in
thinking, emotional reactions, and
behavior.
In addition, Clozaril is used to
treat thought, emotional and
behavioral disturbances in
patients with Parkinson’s disease,
when standard treatment has
failed. Parkinson’s disease is a
chronic (persistent) disorder of
the brain. It mainly affects the
way the brain co-ordinates the
movements of the muscles in
various parts of the body.
HOW CLOZARIL WORKS
Clozaril predominantly works by
binding to and blocking the D4
receptor (or dopamine receptor) in
the brain. Clozaril also has weak
binding and blocking activity on
the D1, D2, D3 and D5 receptors
in the brain as well as other
receptors that potentially have
some contribution to its
effectiveness.
BEFORE YOU USE CLOZARIL
Clozaril may only be taken if
prescribed by a doctor.
Follow all doctor’s instructions
carefully, even if they differ from
the general information contained
in this leaflet.
Before starting Clozaril, you will
have a blood test to make sure
that you can take this medicine.
_When you must n

Lastnosti izdelka

DESCRIPTION AND COMPOSITION
25 mg Tablet: Each tablet contains 25 mg clozapine.
100 mg Tablet: Each tablet contains 100 mg clozapine.
DESCRIPTION
Clozaril 25mg : Circular, flat, yellow, beveled edges tablet.
Approximately 6.3mm diameter,
coded CLOZ on one side, L/O and angle score on reverse.
Clozaril 100mg : Circular, flat, yellow, beveled edges tablet.
Approximately 10.0mm
diameter, coded CLOZ on one side, Z/A and angle score on the other
side.
PHARMACEUTICAL FORM
Tablets. The scored tablets can be divided into equal halves.
ACTIVE SUBSTANCE
Clozapine
Certain dosage strength may not be available in all countries.
ACTIVE MOIETY
Clozapine
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 BEHAVIOR (SEE SECTION INDICATIONS),
•
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
WARNINGS AND PRECAUTIONS).
•
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
WARNINGS AND
PRECAUTIONS).
CLOZARIL MUST BE DISPENSED UNDER STRICT MEDICAL SUPERVISION IN
ACCORDANCE WITH OFFICIAL
RECOMMENDATIONS (SEE SECTION WARN