GPO-L-One Tablet 500mg

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

DEFERIPRONE

Boleh didapati daripada:

IMEKS PHARMA SDN. BHD.

INN (Nama Antarabangsa):

DEFERIPRONE

Unit dalam pakej:

100tablet Tablets

Dikeluarkan oleh:

The Government Pharmaceutical Organization

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
GPO-L-ONE TABLET 500MG
Deferiprone (500 mg)
_ _
1
WHAT IS IN THE LEAFLET
1.
What GPO-L-One is used for
2.
How GPO-L-One works
3.
Before you use GPO-L-One
4.
How to use GPO-L-One
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of GPO-L-One
8.
Product Description
9.
Manufacturer and Product Registration
Holder
10.
Date of Revision
WHAT GPO-L-ONE IS USED FOR
GPO-L-One is used to treat iron overload
caused
by
frequent
blood
transfusions
in
patients with thalassaemia major (a type of
anaemia).
HOW GPO-L-ONE WORKS
GPO-L-One
contains
the
active
ingredient
deferiprone. It helps to remove excess iron
from the body.
BEFORE YOU USE GPO-L-ONE _ _
-
_When you must not use it_
Do not take GPO-L-One if you:
• Are allergic to deferiprone or any other
ingredients in the formulation.
•
Have
history
of
repeated
episodes
of
neutropenia (low white blood cells count).
• Have history of agranulocytosis (very low
white blood cell count).
• Are pregnant or breast-feeding.
-
_Before you start to use it _
Tell your doctor if you have allergies to:
•
Any
other
substances,
including
foods,
preservatives or dyes.
Tell your doctor if you have or have had any
medical conditions, especially the following:
• Neutropenia or agranulocytosis
• Kidney problems
• Liver problems
•
HIV
positive
or
any
impaired
immune
system problems
• Low serum ferritin level
Your doctor will also ask you to come in for
tests to monitor body iron load. In addition
he or she also might ask you to undergo liver
biopsies.
-
_Taking other medicines _
Inform your doctor or pharmacist if you are
taking or if you have recently taken any other
medicines,
including
medicines
obtained
without a prescription.
Some
medicines
and
GPO-L-One
may
interfere with each other. It is important to
tell
your
doctor
or
pharmacist
if
you
are
taking:
•
Aluminium-based
antacids
(relieve
heartburn or indigestion caused by excess
stomach acid)
• Medicines known to cause neutropenia or
agranulocytosis
• Vit

Ciri produk

DOSAGE FORM / STRENGTH
Film coated tablet, each tablet contains Deferiprone 500 mg.
DESCRIPTION
Dark green, oblong biconvex, film-coated tablet, one side
bisected with DFP and 500 marked on each section.
PROPERTIES
Deferiprone (L1) is an orally active iron chelator belonging to
the group of hydroxypyridones. It binds to iron in a 3:1 molar
ratio. The water soluble complex of iron formed is rapidly
excreted in the urine thus reducing pathological iron deposits
in
organs
and
tissues.
Studies
have
demonstrated
that
deferiprone is effective in promoting iron excretion and can
lower serum ferritin levels and tissue iron stores in patients with
transfusion-dependent thalassaemia, however, the precise
mechanism of deferiprone in promoting iron excretion and
preventing the progress of iron accumulation is unknown.
_PHARMACOKINETICS_
Absorption: Deferiprone is rapidly absorbed from the upper
part of the gastrointestinal tract. Peak serum concentrations
are reached 45 to 60 minutes following administration of a
single dose in fasted patients. This may be extended to 2 hours
in fed patients. There was no decrease in the amount of drug
absorbed when given with food.
Biotransformation: Deferiprone is metabolized predominantly
to a glucuronide conjugate. Peak serum concentrations of
the glucuronide occur 2 to 3 hours after administration of
deferiprone.
Elimination: Deferiprone is eliminated mainly via kidneys (75%
to 90% of ingested dose reportedly recoverable from urine
during the first 24 hours), in the form of free deferiprone, the
glucuronide metabolite and the iron-deferiprone complex.
The elimination half-life in most patients is 2 to 3 hours.
INDICATION
GPO-L-ONE TABLET is indicated for treatment of iron overload
in
patients
with
thalassaemia
major
when
deferoxamine
therapy is contraindicated or inadequate.
RECOMMENDED DOSAGE
ADULT & CHILDREN OVER 6 YEARS
GPO-L-ONE TABLET is given orally, 75 MG/KG BODY WEIGHT DAILY,
IN 2 TO 4 DIVIDED DOSES. Dosage per kg body weight should be
calculated to the nearest half tablet (see