Clozaril 100mg tablets

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiivinen ainesosa:

Clozapine

Saatavilla:

Viatris UK Healthcare Ltd

ATC-koodi:

N05AH02

INN (Kansainvälinen yleisnimi):

Clozapine

Annos:

100mg

Lääkemuoto:

Oral tablet

Antoreitti:

Oral

luokka:

No Controlled Drug Status

Prescription tyyppi:

Valid as a prescribable product

Tuoteyhteenveto:

BNF: 04020100; GTIN: 5013054030256 5013054030119 5010678903010

Pakkausseloste

V1 Mar 2022
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CLOZARIL, 25 mg, 100 mg, 100
02 MAY 2022
11:00
Leaflet/IFU - Folded
front 2326; back 2327
ART-23978-01
400534691, 400534700
N.A.
N.A.
1
1 of 2
8 pt
8 pt
ART-23978-01
3
PL 46302/0054, PL 46302/0057
United Kingdom
Klocke Verpackungs-Service
GmbH (Weingarten - DE)
N.A.
600098784
N.A.
N.A.
News Gothic MT
N.A.
185x 510 mm
Black
Keyline
Package Leaflet: Information for the user
CLOZARIL
®
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
sh

Valmisteyhteenveto

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Clozaril
®
100 mg Tablets.
UK CLOZARIL
® OFFICIAL RECOMMENDATIONS
As a consequence of a recent European regulatory initiative, the
Clozaril 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 UK 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 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 to hospital and retail pharmacies registered with the
Clozaril Patient
Monitoring Service. Clozaril 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 Clozaril Patient Monitoring Service