Zaponex 25mg tablets

Land: Storbritannien

Språk: engelska

Källa: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiva substanser:

Clozapine

Tillgänglig från:

Leyden Delta B.V.

ATC-kod:

N05AH02

INN (International namn):

Clozapine

Dos:

25mg

Läkemedelsform:

Oral tablet

Administreringssätt:

Oral

Klass:

No Controlled Drug Status

Receptbelagda typ:

Valid as a prescribable product

Produktsammanfattning:

BNF: 04020100; GTIN: 5017007062714 5017007062738

Bipacksedel

WHAT IS IN THIS LEAFLET:
1.
WHAT ZAPONEX IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
ZAPONEX
3.
HOW TO TAKE ZAPONEX
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE ZAPONEX
6.
CONTENTS OF THE PACK AND FURTHER
INFORMATION 1
WHAT ZAPONEX IS AND
WHAT IT IS USED FOR
The active ingredient of Zaponex is clozapine
which belongs to a group of medicines called
antipsychotics (medicines that are used to treat
specific mental disorders such as psychosis).
Zaponex
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.
Zaponex
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 ZAPONEX
DO NOT TAKE ZAPONEX IF YOU:
• are allergic (hypersensitive) to clozapine or
any of the other ingredients of Zaponex (see
section 6)
• are not able to have regular blood tests
• have ever been told you have a low white
blood
cell
count
(e.g.
leukopenia
or
agranulocytosis), especially if this was caused
by medicines. This does not apply if you have
had low white blood cell count caused by
previous chemotherapy.
• suffer from bone marrow disease or have
ever suffered from bone marrow disease
• use
any
medicine
that
stops
your
bone
marrow from working properly
• use any medicine that reduces the number of
white cells in your blood
• had
to
stop
using
clozapine
previously
because
of
severe
side
effects
(e.g.
agranulocytosis or heart problems)
• suffer from uncontrolled epilepsy (seizures or
fits)
• have
an
acute
mental
illness
caused
by
alcohol or drugs (e.g. narcotics)
• suffer from myocarditis (an

Produktens egenskaper

SUMMARY OF PRODUCT CHARACTERISTICS (SMPC)
1.
NAME OF THE MEDICINAL PRODUCT
Zaponex 25 mg Tablets.
UK Zaponex® Official Recommendations
As a consequence of a recent European regulatory initiative, the
Zaponex 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 Zaponex Treatment Access System (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 Zaponex is used in conjunction
with the Zaponex
Treatment Access System, of 0.01%[2].
The Zaponex Treatment Access System provides for the centralised
monitoring of leukocyte
and neutrophil counts which is a mandatory requirement for all
patients in the UK who are
treated with Zaponex. The use of Zaponex is restricted to patients who
are registered with the
Zaponex Treatment Access System. In addition to registering their
patients, prescribing
physicians must register themselves and a nominated pharmacist with
the Zaponex Treatment
Access System. All Zaponex-treated patients must be under the
supervision of an appropriate
specialist and supply of Zaponex is restricted to hospital and retail
pharmacies registered with
the Zaponex Treatment Access System. Zaponex is not sold to, or
distributed through
wholesalers.
In the UK, 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
•
Monitoring must continue throughout treatment and for at least 4 weeks
after
discontinuation
The Zaponex Treatment Access System maintains a database which
includes al