Leponex 25mg Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CLOZAPINE

Available from:

Novartis Pharmaceuticals UK Limited Frimley Business Park, Frimley Camberley, Surrey GU16 7SR, United Kingdom

ATC code:

N05AH02

INN (International Name):

CLOZAPINE 25 mg

Pharmaceutical form:

TABLET

Composition:

CLOZAPINE 25 mg

Prescription type:

POM

Therapeutic area:

PSYCHOLEPTICS

Authorization status:

Withdrawn

Authorization date:

2006-08-10

Patient Information leaflet

Page 1 of 12
PACKAGE LEAFLET: INFORMATION FOR THE USER
LEPONEX®
LEPONEX 25 MG TABLETS
LEPONEX 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, pharmacist or
healthcare provider.
-
This medicine has been prescribed for you only. Do not use it for any
other illnesses. 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 Leponex is and what it is used for
2.
What you need to know before you take Leponex
3.
How to take Leponex
4.
Possible side effects
5.
How to store Leponex
6.
Contents of the pack and other information
1. WHAT LEPONEX IS AND WHAT IT IS USED FOR
Leponex tablets contain an active substance called clozapine. This
medicine belongs to a group
of medicines called antipsychotics (medicines that are used to treat
specific mental disorders
such as psychosis).
Leponex 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 tried at least two other medicines to
treat schizophrenia before, and
these medicines did not work, or caused severe side effects that
cannot be treated.
Leponex 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.
HOW LEPONEX WORKS
Leponex predominantly
works by
binding to and
blocking the
D4 receptor (or
dopamine
receptor) in the brain. Leponex also has weak binding and blocking
activity on the D1, D2, D3
and D5 receptors in the brain as well as other receptors that
potentially have some contribution to

Summary of Product characteristics

Page 1 of 32 SUMMARY OF PRODUCT CHARACTERISTICS
LEPONEX 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 LEPONEX.
PRESCRIBING PHYSICIANS
MUST COMPLY FULLY
WITH THE REQUIRED SAFETY MEASURES. AT EACH
CONSULTATION,
A
PATIENT
RECEIVING
LEPONEX
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.
LEPONEX MUST BE DISPENSED UNDER STRICT MEDICAL SUPERVISION IN
ACCORDANCE WITH OFFICIAL
RECOMMENDATIONS.
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.
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.
IF MYOCARDITIS OR CARDIOMYOPATHY ARE SUSPECTED, LEPONEX TREATMENT
SHOULD BE PROMPTLY
STOPPED AND THE PATIENT IMMEDIATELY REFERRED TO A CARDIOLOGIST.
PATIENTS WH