LEPONEX 25 MG TABLETS

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

CLOZAPINE

Available from:

DEVRIES & CO. LTD

ATC code:

N05AH02

Pharmaceutical form:

TABLETS

Composition:

CLOZAPINE 25 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

MYLAN PHARMA GMBH, SWITZERLAND

Therapeutic area:

CLOZAPINE

Therapeutic indications:

Treatment of resistant schizophrenic patients who are non-responsive to, or intolerant of classic neuroleptics. Reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at chronic risk for re-experiencing suicidal behavior, based on history and recent clinical state. Suicidal behavior refers to actions by a patient that put him/herself at risk for death.

Authorization date:

2022-10-31

Patient Information leaflet

Patient leaflet in accordance with the Pharmacists' Regulations
(Preparations) - 1986
This medicine is dispensed with a doctor's prescription only
Leponex 25 mg tablets
Leponex 100 mg tablets
Active ingredient:
Each tablet contains:
Each tablet contains:
Clozapine 25 mg
Clozapine 100 mg
Inactive ingredients and allergens: See section 6 under ‘Additional
information’ and ‘Important information about some of this
medicine’s
ingredients’ in section 2.
Preparation dispensing instructions:
During the first 18 weeks:
Perform a blood test once a week during the first 18 weeks.
The community pharmacy will dispense the medicine for one week of
treatment only, according to a doctor's prescription, provided that it
carries the stamp:
“White blood cell test was performed, and the results are normal”.
Starting from week 19 of treatment:
A blood test must be performed at least once a month.
The community pharmacy will dispense the medicine for one month of
treatment only, according to a doctor's prescription, provided that it
carries the stamp:
“White blood cell test was performed, and the results are normal”.
Read the entire leaflet carefully before you start using this
medicine. This
leaflet contains concise information about this medicine. If you have
any further
questions, consult your doctor or pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to
others. It may harm them, even if it seems to you that their illness
is similar to
yours.
Before starting treatment with Leponex, blood tests must be performed
to make
sure that you can take the medicine.
1.
What is this medicine intended for?
Leponex is used for treatment in resistant schizophrenic patients who
are non-
responsive to, or intolerant of other antipsychotic medicines.
The medicine is also intended for reducing the risk of recurrent
suicidal behaviour
in patients with schizophrenia or schizoaffective disorder who are at
long-term
risk due to suicidal behaviour, based on previous history.
Therapeutic group: Atypi

Summary of Product characteristics

1
1.
NAME OF THE MEDICINAL PRODUCT
Leponex
®
25 mg tablets
Leponex
®
100 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance_: _clozapine
Excipient with known effect: lactose_. _
For the full list of excipients, see section 6.1.
Leponex can cause agranulocytosis. Its use should be limited to
patients:
•
with schizophrenia who are non-responsive to or intolerant of
classical
antipsychotic agents, or with schizophrenia or schizoaffective
disorder who are at risk
of recurrent suicidal behaviour (see “Indications”),
•
who have initially absolute neutrophil counts (ANC) ≥ 2,000 per mm
3
, and at
least 1,500 per mm
3
patients with documented Benign Ethnic Neutropenia (BEN).
•
and in whom regular white blood cell counts and absolute neutrophil
counts
can be performed as follows: weekly during the first 18 weeks of
therapy, and at least
every 4 weeks thereafter throughout treatment. Monitoring must
continue throughout
treatment and for 4 weeks after complete discontinuation of Leponex
(see “Warnings and
precautions”).
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
p e r s i s t e n t
t a c h y c a r d i a
a t
r e s t ,
e s p e c i a l l y
i n
t h e
f i r s t
2
m o n t h s
o f
t r e a t m e n t ,
a n d / o r
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 who develop clozapine-induced myocarditis or cardiomyopathy
should not be
re-exposed to clozapine.
Increase mortality in elderly patients with dementia related psychosi