CLOZARIL TABLET 25 mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Clozapine base

Available from:

MYLAN PHARMACEUTICALS PTE. LTD.

ATC code:

N05AH02

Dosage:

25 mg

Pharmaceutical form:

TABLET, FILM COATED

Composition:

Clozapine base 25 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

MADAUS GmbH

Authorization status:

ACTIVE

Authorization date:

1992-11-06

Patient Information leaflet

CLOZARIL CAN CAUSE AGRANULOCYTOSIS. ITS USE SHOULD BE LIMITED TO
PATIENTS:
• WHO ARE NON-RESPONSIVE TO OR INTOLERANT OF CLASSICAL ANTIPSYCHOTIC
AGENTS
• 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 WARNINGS AND PRECAUTIONS).
MYOCARDITIS
CLOZAPINE IS ASSOCIATED WITH AN INCREASED RISK OF MYOCARDITIS WHICH
HAS, IN RARE CASES, BEEN FATAL.
THE INCREASED RISK OF MYOCARDITIS IS GREATEST IN THE FIRST 2 MONTHS OF
TREATMENT. FATAL CASES OF
CARDIOMYOPATHY HAVE ALSO BEEN REPORTED RARELY.
MYOCARDITIS OR CARDIOMYOPATHY SHOULD BE SUSPECTED IN PATIENTS WHO
EXPERIENCE PERSISTANT
TACHYCARDIA AT REST, ESPECIALLY IN THE FIRST 2 MONTHS OF TREATMENT,
AND/OR PALPITATIONS, ARRHYTHMIAS,
CHEST PAIN AND OTHER SIGNS AND SYMPTOMS OF HEART FAILURE (EG.
UNEXPLAINED FATIGUE, DYSPNOEA,
TACHYPNOEA) OR SYMPTOMS THAT MIMIC MYOCARDIAL INFARCTION.
IF MYOCARDITIS OR CARDIOMYOPATHY ARE SUSPECTED, CLOZARIL TREATMENT
SHOULD BE PROMPTLY STOPPED AND
THE PATIENT IMMEDIATELY REFERRED TO A CARDIOLOGIST.
PATIENTS WHO DEV

Summary of Product characteristics

Live Text:
Production Site:
Singapore
Comp. No. New:
708732
N/A
172 x 600 mm
WZ_468_BPZ_172x600_Kennzeich_
IMA_C80
Comp. No. Old:
Printing Colours:
Technical Colours:
PANTONE Black C
Format/Dimension:
Tech. Drawing No.:
Min. Font Size Text:
Braille:
N/A
! PLEASE TURN OVERPRINTING ON !
PR:
2590585
Comp. Description:
Clozaril 25mg & 100mg PI Revised
ACC:
NA
Cutting
Font Type:
Proof No.:
Arul
Date:
02
28 Sep 2022
No /
Both
Yes /
Pharmacode
Clozaril can cause agranulocytosis. Its use should be limited to
patients:
•
with schizophrenia who are non-responsive to or intolerant of
classical
antipsychotic agents.
•
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
(≥2.10 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
discontinua-
tion 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 WARNINGS AND PRECAUTIONS).
Myocarditis
Clozapine is associated with an increased risk of myocarditis which
has, in rare
cases, been fatal. The increased risk of myocarditis is greatest in
the first 2
months of treatment. Fatal cases of cardiomyopathy have also been
reported
rarely.
Myocarditis or cardiomyopathy should be suspecte