CLOZARIL 100 Milligram Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

CLOZAPINE

Available from:

Mylan Products Limited

ATC code:

N05AH02

INN (International Name):

CLOZAPINE

Dosage:

100 Milligram

Pharmaceutical form:

Tablets

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Antipsychotics

Authorization status:

Authorised

Authorization date:

2016-11-04

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
CLOZARIL 25MG TABLETS
CLOZARIL 100 MG TABLETS_ _
clozapine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Clozaril is and what it is used for
2.
What you need to know before you take Clozaril
3.
How to take Clozaril
4.
Possible side effects
5.
How to store Clozaril
6.
Contents of the pack and other information
1.
WHAT CLOZARIL IS AND WHAT IT IS USED FOR
The active ingredient of Clozaril is clozapine which belongs to a
group of medicines called antipsychotics
(medicines that are used to treat specific mental disorders such as
psychosis).
Clozaril is used to treat people with schizophrenia in whom other
medicines have not worked. Schizophrenia
is a mental illness which affects how you think, feel and behave. You
should only use this medicine if you
have already tried at least two other antipsychotic medicines,
including one of the newer atypical
antipsychotics, to treat schizophrenia before, and these medicines did
not work, or caused severe side effects
that cannot be treated.
Clozaril is also used to treat severe disturbances in the thoughts,
emotions and behaviour of people with
Parkinson’s disease in whom other medicines have not worked.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CLOZARIL
DO NOT TAKE CLOZARIL IF YOU:
-
are allergic (hypersensitive) to clozapine or any of the other
ingredients of Clozaril (listed in section
6).
-
are not able to have regular blood tests.
-
have ever been told you have a low white blood cell count (e.g.
leucopenia or

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
CLOZARIL CAN CAUSE AGRA
NULOCYTOSIS. ITS USE SHOULD BE LIMITED TO PATIENTS:
-
WITH SCHIZOPHRENIA WHO ARE NON-RESPONSIVE TO OR INTOLERANT OF
ANTIPSYCHOTIC MEDICATION, OR WITH
PSYCHOSIS IN PARKINSON’S DISEASE WHEN OTHER TREATMENT STRATEGIES
HAVE FAILED (SEE SECTION 4.1),
-
WHO HAVE INITIALLY NORMAL LEUKOCYTE FINDINGS (WHITE BLOOD CELL COUNT
3500/MM
3
(
3.5X10
9
/L), AND ANC
2000/MM
3
(
2.0X10
9
/L)), AND
-
IN WHOM REGULAR WHITE BLOOD CELL (WBC) COUNTS AND ABSOLUTE NEUTROPHIL
COUNTS (ANC) CAN BE
PERFORMED AS FOLLOWS: WEEKLY DURING THE FIRST 18 WEEKS OF TREATMENT,
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 MUST COMPLY FULLY WITH THE REQUIRED SAFETY
MEASURES. AT EACH CONSULTATION, A PATIENT
RECEIVING CLOZARIL MUST BE REMINDED TO CONTACT THE TREATING PHYSICIAN
IMMEDIATELY IF ANY KIND OF INFECTION
BEGINS TO DEVELOP. PARTICULAR ATTENTION MUST 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).
CLOZARIL MUST BE DISPENSED UNDER STRICT MEDICAL SUPERVISION IN
ACCORDANCE WITH OFFICIAL RECOMMENDATIONS (SEE
SECTION 4.4).
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 (SEE SECTION 4.4).
MYOCARDITIS OR CARDIOMYOPATHY SHOULD BE SUSPECTED IN PATIENTS WHO
EXPERIENCE PERSISTENT 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 (E.G. UNEXPLAINED FATIGUE, DYSPNOEA,
TACHYPNOEA) OR SYMPTOMS THAT MIMIC
MYOCARDIAL INFARCTION (SEE SECTION 4.4).
IF MYOCARDITIS OR CARDIOMYOPATHY ARE SUSPECTED, CLOZARIL TREATMENT
SHOULD BE PROMPTLY ST