Clozaril 25 mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Clozapine

Available from:

Mylan IRE Healthcare Limited

ATC code:

N05AH; N05AH02

INN (International Name):

Clozapine

Dosage:

25 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

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

Therapeutic area:

Diazepines, oxazepines, thiazepines and oxepines; clozapine

Authorization status:

Marketed

Authorization date:

1992-05-14

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
CLOZARIL 25 MG 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, 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 agra

Summary of Product characteristics

Health Products Regulatory Authority
14 April 2021
CRN00C61G
Page 1 of 20
SUMMARY OF PRODUCT CHARACTERISTICS
IRELAND - CLOZARIL OFFICIAL RECOMMENDATIONS
The UK/IRL Clozaril Patient Monitoring Service (CPMS) was developed in
order to manage the risk of agranulocytosis
associated with clozapine. It is available 24 hours a day. When a
monitoring service is not used, evidence suggests a mortality
rate from agranulocytosis of 0.3%
1
. This is compared to a mortality rate when Clozaril is used in
conjunction with the Clozaril
Patient Monitoring Service, of 0.01%
2
.
The Clozaril Patient Monitoring Service provides for the centralised
monitoring of leucocyte and neutrophil counts which is a
mandatory requirement for all patients in the UK and Ireland who are
treated with Clozaril. The use of Clozaril is restricted to
patients who are registered with the Clozaril Patient Monitoring
Service. In addition to registering their patients, prescribing
physicians must register themselves and a nominated pharmacist with
the Clozaril Patient Monitoring Service. All
Clozaril-treated patients must be under the supervision of an
appropriate specialist and supply of Clozaril is restricted in
Ireland to hospital and retail pharmacies registered with the Clozaril
Patient Monitoring Service. Clozaril may only be supplied
by way of wholesale dealing by wholesalers which have been
specifically qualified by the Marketing Authorisation Holder to
supply the product and which have adequate controls in place to assure
that only authorised Clozaril customers receive
consignments of the product. The Marketing Authorisation Holder has
agreed in advance with the HPRA the use of any
wholesaler in the supply chain of Clozaril.
In the UK and Ireland, a white cell count with a differential count
must be monitored:

At least weekly for the first 18 weeks of treatment.

At least at 2 week intervals between weeks 18 and 52.

After 1 year of treatment with stable neutrophil counts, patients may
be monitored at least at 4 week intervals.

Monito