Denzapine 200 mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Clozapine

Available from:

Clonmel Healthcare Ltd

ATC code:

N05AH; N05AH02

INN (International Name):

Clozapine

Dosage:

200 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:

2009-04-03

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
DENZAPINE
® 25, 50, 100, 200 MG TABLETS
Clozapine
The use of Denzapine is restricted to those patients registered with
the Denzapine Monitoring
Service.
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 possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Denzapine is and what is it used for
2.
What you need to know before you take Denzapine
3.
How to take Denzapine
4.
Possible side effects
5.
How to store Denzapine
6.
Contents of the pack and other information
1.
WHAT DENZAPINE IS AND WHAT IT IS USED FOR
Denzapine contains the active substance clozapine, which belongs to a
group of medicines called
atypical antipsychotics. Antipsychotics are mainly used to treat
schizophrenia. Schizophrenia is a
psychiatric disorder that affects the way a person thinks, feels and
behaves.
Denzapine is used:
-
to treat schizophrenia when at least two other antipsychotic
medicines, including one of the
newer atypical antipsychotics, have not worked or have caused severe
side effects
-
to treat psychotic disorders occurring in patients with Parkinson’s
disease, when standard
treatment has failed.
Denzapine is available only with a doctor’s prescription. Ask your
doctor if you have any
questions about why this medicine has been prescribed for you.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DENZAPINE
DO NOT TAKE DENZAPINE:
-
if you are allergic to clozapine or to any of the other ingredients of
this medicine (listed in
section 6). It is important to tell your doctor if you think you have
ever had an allergic
reaction to any of th

Summary of Product characteristics

Health Products Regulatory Authority
12 October 2023
CRN00D6N5
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.
As a consequence of a recent European regulatory initiative, the
Denzapine Summary of Product Characteristics (SmPC) has
been harmonised across Europe. The SmPC states that blood monitoring
should be carried out in accordance with
national-specific official recommendations. These are reproduced
below.
The Denzapine Monitoring Service (DMS) 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].
The Denzapine Monitoring Service provides centralised monitoring of
leucocyte and neutrophil counts which is a mandatory
requirement for all patients in the UK and Ireland who are treated
with Denzapine. The use of Denzapine is restricted to
patients who are registered with the Denzapine Monitoring Service. In
addition to registering their patients, prescribing
physicians must register themselves and a nominated pharmacist with
the Denzapine Monitoring Service. All
Denzapine-treated patients must be under the supervision of an
appropriate specialist and supply of Denzapine is restricted to
hospital and retail pharmacies registered with the Denzapine
Monitoring Service. Denzapine 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 ran