Leydex 100 mg Orodispersible Tablets

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

Clozapine

Disponible desde:

Leyden Delta BV

Código ATC:

N05AH; N05AH02

Designación común internacional (DCI):

Clozapine

Dosis:

100 milligram(s)

formulario farmacéutico:

Orodispersible tablet

Área terapéutica:

Diazepines, oxazepines, thiazepines and oxepines; clozapine

Fecha de autorización:

2019-04-12

Información para el usuario

Page 1 of 13
PACKAGE LEAFLET: INFORMATION FOR THE USER
LEYDEX
® 12.5 MG ORODISPERSIBLE TABLETS
LEYDEX
® 25 MG ORODISPERSIBLE TABLETS
LEYDEX
® 50 MG ORODISPERSIBLE TABLETS
LEYDEX
® 100 MG ORODISPERSIBLE TABLETS
LEYDEX
® 200 MG ORODISPERSIBLE 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 Leydex is and what it is used for
2.
What you need to know before you take Leydex
3.
How to take Leydex
4.
Possible side effects
5.
How to store Leydex
6.
Contents of the pack and other information
1
WHAT LEYDEX IS AND WHAT IT IS USED FOR
The active substance of Leydex is clozapine which belongs to a group
of medicines called
antipsychotics (medicines that are used to treat specific mental
disorders such as psychosis).
Leydex 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.
Leydex 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.
Page 2 of 13
2
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LEYDEX
DO NOT TAKE LEYDEX IF YOU
-
are allergic (hypersensitive) to clozapine or any of the other
ingredients of this medicine

Ficha técnica

Health Products Regulatory Authority
20 July 2022
CRN00CTLN
Page 1 of 19
SUMMARY OF PRODUCT CHARACTERISTICS
IE Leydex® Official Recommendations
The Leydex monitoring service, named ZTAS, 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
clozapine is used in conjunction with a monitoring
service, of 0.01%[2].
ZTAS provides for the centralised monitoring of leukocyte and
neutrophil counts which is a mandatory requirement for all
patients in Ireland who are treated with Leydex. The use of Leydex is
restricted to patients who are registered with ZTAS. In
addition to registering their patients, prescribing physicians must
register themselves and a nominated pharmacist with ZTAS.
All Leydex-treated patients must be under the supervision of an
appropriate specialist and supply of Leydex is restricted to
hospital and retail pharmacies registered with ZTAS. Leydex is not
sold to, or distributed through wholesalers.
The patient's 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 blood counts (green range),
patients may be monitored at least at 4 week
intervals

Monitoring must continue throughout treatment and for at least 4 weeks
after discontinuation
If the blood result of a patient taking Leydex is below the normal
range (See Section 4.4), Leyden Delta will contact the
physician and pharmacist registered to the patient on ZTAS to inform
them.
ZTAS maintains a database which includes all patients who have
developed abnormal leukocyte or neutrophil findings and who
should not be re-exposed to Leydex or any other brand of clozapine.
Prescribers and pharmacists should adhere to brand prescribing and
dispensing of clozapine in order to preven