Clozaril 25 mg tablets

Land: Malta

Språk: engelsk

Kilde: Medicines Authority

Tilgjengelig fra:

Viatris Healthcare Limited Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN , Ireland

ATC-kode:

N05AH02

INN (International Name):

CLOZAPINE 25 mg

Legemiddelform:

TABLET

Sammensetning:

CLOZAPINE 25 mg

Resept typen:

POM

Terapeutisk område:

PSYCHOLEPTICS

Autorisasjon status:

Authorised

Autorisasjon dato:

2023-11-08

Informasjon til brukeren

PAGE 1 OF 11
PACKAGE LEAFLET: INFORMATION FOR THE USER
CLOZARIL 25 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, 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 agranulocytosis),

Preparatomtale

PAGE 1 OF 22
SUMMARY OF PRODUCT CHARACTERISTICS
CLOZARIL CAN CAUSE AGRANULOCYTOSIS. 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 TRE