Denzapine 50mg tablets

País: Reino Unido

Língua: inglês

Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes ativos:

Clozapine

Disponível em:

Britannia Pharmaceuticals Ltd

Código ATC:

N05AH02

DCI (Denominação Comum Internacional):

Clozapine

Dosagem:

50mg

Forma farmacêutica:

Oral tablet

Via de administração:

Oral

Classe:

No Controlled Drug Status

Tipo de prescrição:

Valid as a prescribable product

Resumo do produto:

BNF: 04020100; GTIN: 5055962500124

Folheto informativo - Bula

will be performed every 4 weeks for as long as you continue to take
Denzapine. Tests
will also be performed for one month after stopping the medicine.
These tests will tell
the doctor if there is any problem with the number of white cells in
your blood. There are
some situations where you may need to have blood tests more often
(e.g. twice a week).
Your doctor will talk to you about this.
If the number of your white blood cells falls below a critical level,
Denzapine must be
stopped immediately and you must never take any medicines containing
clozapine again.
You will need to have blood tests for another 4 weeks after the end of
Denzapine
treatment. Your doctor will also do a physical examination before
starting treatment.
Your doctor may do an electrocardiogram (ECG) to check your heart, but
only if this is
necessary for you, or if you have any special concerns.
Denzapine may cause alteration in blood lipids (fats), and may cause
weight gain. Your
doctor may monitor your weight and blood lipid level.
If you have a liver disorder you will need regular liver function
tests for as long as you
continue to take Denzapine.
If Denzapine makes you feel light-headed, dizzy or faint, or if you
already suffer from
these feelings, be careful when getting up from a sitting or lying
position as this may
increase the possibility of falling.
If you have to undergo surgery or if for some reason you are unable to
walk around for a
long time, discuss with your doctor the fact that you are taking
Denzapine. You may be at
risk of thrombosis (blood clotting within a vein).
Be careful when drinking alcohol or when taking antihistamines
(medicines used for
hay fever, allergies or colds), sleeping tablets or tablets to relieve
pain while taking this
medicine. Denzapine can increase drowsiness caused by alcohol and by
medicines
affecting your nervous system.
Denzapine may affect the way your body controls temperature, and it
may prevent
sweating even in very hot weather. Exercise, hot baths or saunas may
make you feel dizzy
or faint whil

Características técnicas

SUMMARY OF PRODUCT CHARACTERISTICS
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 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 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 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 Denzapine is below the normal
range
(See
Section
4.4),
Britannia
will
contact
the
physician
and
pharmacist
registered to the pat