Clozapine Accord 25 mg tablets

Land: Malta

Sprache: Englisch

Quelle: Medicines Authority

Wirkstoff:

CLOZAPINE

Verfügbar ab:

Accord Healthcare Ireland Ltd Euro House, Euro Business Park, Little Island Cork, T45 K857, Ireland

ATC-Code:

N05AH02

INN (Internationale Bezeichnung):

CLOZAPINE 25 mg

Darreichungsform:

TABLET

Zusammensetzung:

CLOZAPINE 25 mg

Verschreibungstyp:

POM

Therapiebereich:

PSYCHOLEPTICS

Produktbesonderheiten:

Licence number in the source country: NOT APPLICAPABLE

Berechtigungsstatus:

Withdrawn

Berechtigungsdatum:

2020-11-13

Gebrauchsinformation

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Clozapine Accord 25 mg tablets
Clozapine Accord 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 Clozapine Accord is and what it is used for
2.
What you need to know before you take Clozapine Accord
3.
How to take Clozapine Accord
4.
Possible side effects
5.
How to store Clozapine Accord
6.
Contents of the pack and other information
1.
WHAT CLOZAPINE ACCORD IS AND WHAT IT IS USED FOR
The active ingredient of Clozapine Accord is clozapine which belongs
to a group of medicines
called antipsychotics (medicines that are used to treat specific
mental disorders such as psychosis).
Clozapine Accord 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.
Clozapine Accord 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 CLOZAPINE ACCORD
DO NOT TAKE CLOZAPINE ACCORD
−
If you are allergic to clozapine or any of the other ingredients of
this medicine (listed in section
6).
−
If you are not able to ha

Fachinformation

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CLOZAPINE CAN CAUSE AGRANULOCYTOSIS. ITS USE SHOULD BE LIMITED TO
PATIENTS:
•
WITH SCHIZOPHRENIA WHO ARE NON-RESPONSIVE TO OR INTOLERANT OF
ANTIPSYCHOTIC MEDICATION, OR
WITH PSYCHOSIS IN PARKINSON'S DISEASE WHEN OTHER TREATMENT STRATEGIES
HAVE FAILED (SEE
SECTION 4.1),
•
WHO
HAVE
INITIALLY
NORMAL
LEUKOCYTE
FINDINGS
(WHITE
BLOOD
CELL
COUNT
≥
3500/MM
3
(3.5X10
9
/L), AND ANC ≥ 2000/MM
3 (≥2.0X10
9
/L)), AND
•
IN WHOM REGULAR WHITE BLOOD CELL (WBC) COUNTS AND ABSOLUTE NEUTROPHIL
COUNTS (ANC) CAN
BE PERFORMED AS FOLLOWS: WEEKLY DURING THE FIRST 18 WEEKS OF
TREATMENT, AND AT LEAST EVERY
4 WEEKS THEREAFTER THROUGHOUT TREATMENT. MONITORING MUST CONTINUE
THROUGHOUT TREATMENT
AND FOR 4 WEEKS AFTER COMPLETE DISCONTINUATION OF CLOZAPINE (SEE
SECTION 4.4.).
PRESCRIBING
PHYSICIANS
MUST
COMPLY
FULLY
WITH
THE
REQUIRED
SAFETY
MEASURES.
AT
EACH
CONSULTATION, A PATIENT RECEIVING CLOZAPINE MUST BE REMINDED TO
CONTACT THE TREATING PHYSICIAN
IMMEDIATELY IF ANY KIND OF INFECTION BEGINS TO DEVELOP. PARTICULAR
ATTENTION MUST BE PAID TO
FLU-LIKE COMPLAINTS SUCH AS FEVER OR SORE THROAT AND TO OTHER EVIDENCE
OF INFECTION, WHICH MAY
BE INDICATIVE OF NEUTROPENIA (SEE SECTION 4.4).
CLOZAPINE MUST BE DISPENSED UNDER STRICT MEDICAL SUPERVISION IN
ACCORDANCE WITH OFFICIAL
RECOMMENDATIONS (SEE SECTION 4.4).
MYOCARDITIS
CLOZAPINE IS ASSOCIATED WITH AN INCREASED RISK OF MYOCARDITIS WHICH
HAS, IN RARE CASES, BEEN
FATAL. THE INCREASED RISK OF MYOCARDITIS IS GREATEST IN THE FIRST 2
MONTHS OF TREATMENT. FATAL
CASES OF CARDIOMYOPATHY HAVE ALSO BEEN REPORTED RARELY (SEE SECTION
4.4).
MYOCARDITIS OR CARDIOMYOPATHY SHOULD BE SUSPECTED IN PATIENTS WHO
EXPERIENCE PERSISTENT
TACHYCARDIA
AT
REST,
ESPECIALLY
IN
THE
FIRST
2
MONTHS
OF
TREATMENT,
AND/OR
PALPITATIONS,
ARRHYTHMIAS, CHEST PAIN AND OTHER SIGNS AND SYMPTOMS OF HEART FAILURE
(E.G. UNEXPLAINED
FATIGUE, DYSPNOEA, TACHYPNOEA) OR SYMPTOMS THAT MIMIC MYOCARDIAL
INFARCTION (SEE SECTION
4.4).
IF MYOCARDITIS OR CARDIOMYOPATHY IS SUSPECTED, CLOZAPINE TREATMENT
SHOULD BE PROMPTLY
STOPPED