CLOZARIL 100MG TABLETS

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Beli sekarang

Risalah maklumat Risalah maklumat (PIL)
27-02-2019
Ciri produk Ciri produk (SPC)
16-02-2019

Bahan aktif:

CLOZAPINE

Boleh didapati daripada:

MYLAN HEALTHCARE SDN. BHD.

INN (Nama Antarabangsa):

CLOZAPINE

Unit dalam pakej:

50Tablet Tablets

Dikeluarkan oleh:

NOVARTIS SAGLIK

Risalah maklumat

                                CLOZARIL
®
_Consumer Medication Information Leaflet (RiMUP) _
1
CLOZAPINE
25 MG OR 100 MG TABLETS
WHAT IS IN THIS LEAFLET
1.
WHAT CLOZARIL IS USED FOR
2.
HOW CLOZARIL WORKS
3.
BEFORE YOU USE CLOZARIL
4.
HOW TO USE CLOZARIL
5.
WHILE YOU ARE USING
CLOZARIL
6.
SIDE EFFECTS
7.
STORAGE AND DISPOSAL OF
CLOZARIL
8.
PRODUCT DESCRIPTION
9.
MANUFACTURER AND PRODUCT
REGISTRATION HOLDER
10.
DATE OF REVISION
WHAT CLOZARIL IS USED FOR
Clozaril tablets contain an active
substance called clozapine. This
medicine belongs to a group of
medicines called antipsychotics.
Clozaril is used to treat people
suffering from schizophrenia who
have either tried other
antipsychotic medications and did
not benefit sufficiently or who are
unable to tolerate other
antipsychotic medications
because of side effects.
Clozaril is also used to treat
people suffering from
schizophrenia or schizoaffective
disorder (schizophrenia with
mood disorders) who might
otherwise attempt to commit
suicide.
Schizophrenia is a mental illness
involving disturbances in
thinking, emotional reactions and
behaviour.
In addition, Clozaril is used to
treat thought, emotional and
behavioural disturbances in
patients with Parkinson’s disease,
when standard treatment has
failed. Parkinson’s disease is a
chronic (persistent) disorder of
the brain. It mainly affects the
way the brain co-ordinates the
movements of the muscles in
various parts of the body.
HOW CLOZARIL WORKS
Clozaril predominantly works by
binding to and blocking the D4
receptor (or dopamine receptor) in
the brain. Clozaril 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 its
effectiveness.
BEFORE YOU USE CLOZARIL
Clozaril may only be taken if
prescribed by a doctor.
Follow all doctor’s instructions
carefully, even if they differ from
the general information contained
in this leaflet.
Before starting Clozaril, you will
have a blood test to make sure
that you can take this medicine.
_When you mu
                                
                                Baca dokumen lengkap
                                
                            

Ciri produk

                                1 of 2
Live Text:		Yes /		No /		BothProduction Site:
Kurtkoy
WO: 1787552 ACC:Yildirim, Mert
Comp. Description: LFT_LEPONEX (CLOZARIL) 25MG /
100MG MY Printing Colours:
Black
Comp. No. New: 1815978 MY
Comp. No. Old: 1815134 MY
Format/Dimension: 594 x 175 mm
Tech. Drawing No.: N/A
Technical Colours:Cutting
Guides
Min. Font Size Text: 7 pt
Font Type: News Gothic
Proof No.: 1Date:18 Jan 2019 J.N.: 369732
Braille: N/A
! PLEASE TURN OVERPRINTING ON !
Telephone +353 (0)1 440 3222
novartis@perigord-as.com
www.perigord-as.com Unit 1, Lyncon Court
IDA Business & Technology Park
Snugborough Rd
Blanchardstown
Dublin 15
Clozaril	®
Antipsychotic agent
Clozaril 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 behavior (see section INDICATIONS).
• who have initially normal leukocyte findings (white blood cell count
(WBC) ≥ 3500/mm
3 (3.5 x 10	9/L), and absolute neutrophil counts
(ANC) ≥ 2000/mm	3 (2.0 x 10	9/ L)).
• 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 Clozaril (see section WARNINGS AND
PRECAUTIONS).
• Prescribing physicians should comply fully with the required safety
measures. At each consultation, a patient receiving Clozaril should be
reminded to contact the treating physician immediately if any kind of
infection begins to develop. Particular attention should 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 WARNINGS AND
PRECAUTIONS).
Clozaril must be dispensed under strict medical supervision in accordance
with official recommendations (
                                
                                Baca dokumen lengkap
                                
                            

Dokumen dalam bahasa lain

Risalah maklumat Risalah maklumat Bahasa Melayu 27-02-2019

Cari amaran yang berkaitan dengan produk ini