Clozalux 100 mg tablets

Country: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Clozapine

Fáanlegur frá:

Rowex Ltd

ATC númer:

N05AH; N05AH02

INN (Alþjóðlegt nafn):

Clozapine

Skammtar:

100 milligram(s)

Lyfjaform:

Tablet

Gerð lyfseðils:

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

Lækningarsvæði:

Diazepines, oxazepines, thiazepines and oxepines; clozapine

Leyfisstaða:

Not marketed

Leyfisdagur:

2007-09-14

Upplýsingar fylgiseðill

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CLOZALUX 25 MG TABLETS
CLOZALUX 50 MG TABLETS
CLOZALUX 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 Clozalux is and what it is used for
2. What you need to know before you take Clozalux
3. How to take Clozalux
4. Possible side effects
5. How to store Clozalux
6. Contents of the pack and other information
1.
WHAT CLOZALUX IS AND WHAT IT IS USED FOR
The active ingredient of Clozalux is clozapine which belongs to a
group of medicines called
antipsychotics (medicines that are used to treat specific mental
disorders such as psychosis).
Clozalux 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.
Clozalux 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 CLOZALUX
DO NOT TAKE CLOZALUX IF YOU
-
are allergic to clozapine or any of the other ingredients of this
medicine (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

Vara einkenni

Health Products Regulatory Authority
17 June 2020
CRN009QVZ
Page 1 of 19
SUMMARY OF PRODUCT CHARACTERISTICS
▼ This medicinal product is subject to additional monitoring. This
will allow quick identification of new safety information.
Healthcare professionals are asked to report any suspected adverse
reactions. See section 4.8 for how to report adverse
reactions.
CLOZAPINE 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 (≥3.5 X 10
9
/L), AND ANC (ABSOLUTE
NEUTROPHIL COUNTS) ≥2000/MM
3 (≥2.0 X 10
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 CLOZAPINE (SEE SECTION 4.4).
PRESCRIBING PHYSICIANS MUST COMPLY FULLY WITH THE REQUIRED SAFETY
MEASURES. AT EACH CONSULTATION, A PATIENT RECEIVING
CLOZAPINE 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).
CLOZAPINE 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
EX