Ferriprox 1000 mg Delayed-Release Tablets

Țară: Malaezia

Limbă: engleză

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

Ingredient activ:

DEFERIPRONE

Disponibil de la:

PHARMAFORTE (MALAYSIA) SDN. BHD.

INN (nume internaţional):

DEFERIPRONE

Unități în pachet:

50 Tablets

Produs de:

APOTEX INC. - ETOBICOKE SITE

Prospect

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
FERRIPROX
®
1000MG DELAYED-RELEASE TABLETS
Deferiprone (1000mg)
WHAT IS IN THIS LEAFLET
1.
What Ferriprox is used for
2.
How Ferriprox works
3.
Before you use Ferriprox
4.
How to use Ferriprox
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Ferriprox
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT FERRIPROX IS USED FOR
Ferriprox is used to treat iron overload in
patients with thalassemia (a type of
blood disorder) major when
deferoxamine therapy is contraindicated
or inadequate.
HOW FERRIPROX WORKS
Ferriprox contains the active substance
deferiprone. Ferriprox removes excess
iron from the body that accumulates
from frequent blood tranfusions.
BEFORE YOU USE FERRIPROX
-
_When you must not use it _
Do not use this product if you are
allergic to deferiprone or any of the
other ingredients of Ferriprox.
Do not use this product if you have a
history of repeated episodes of
neutropenia (low white blood cell
(neutrophil) count), or if you have a
history of agranulocytosis (very low
white blood cell count).
_Pregnancy and lactation _
_ _
Do not take Ferriprox if you are
pregnant, trying to get pregnant or think
you may be pregnant.
Do not take Ferriprox if you are breast-
feeding. Ask your doctor or pharmacist
for advice before taking any medicine.
-
_Before you start to use it _
Before you start to use this product, let
your doctor know if you have any
other known medical condition, or if
you have undergo any type of surgery,
both major or minor.
-
_Taking other medicines _
Do not take aluminium-based antacids
while taking Ferriprox. It is also
advised to consult your doctor or
pharmacist before taking Vitamin C
with Ferriprox.
Tell your doctor if you are taking any
other medicines, including any that
you buy without a prescription from a
pharmacy, supermarket or health food
shop.
HOW TO USE FERRIPROX
-
_How much to use _
The amount of Ferriprox that you take
will depend on your weight. The
recommend

Caracteristicilor produsului

1
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FERRIPROX 1000 MG DELAYED-RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR FERRIPROX DELAYED-RELEASE TABLETS.
FERRIPROX
® 1000 MG DELAYED-RELEASE TABLETS (DEFERIPRONE), FOR ORAL USE
WARNING: AGRANULOCYTOSIS AND NEUTROPENIA
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING. _
•
FERRIPROX CAN CAUSE AGRANULOCYTOSIS THAT CAN LEAD TO SERIOUS
INFECTIONS AND DEATH. NEUTROPENIA MAY PRECEDE THE DEVELOPMENT OF
AGRANULOCYTOSIS. (5.1)
•
MEASURE THE ABSOLUTE NEUTROPHIL COUNT (ANC) BEFORE STARTING
FERRIPROX AND MONITOR REGULARLY WHILE ON THERAPY. (5.1)
•
INTERRUPT FERRIPROX IF NEUTROPENIA DEVELOPS. (5.1)
•
INTERRUPT FERRIPROX IF INFECTION DEVELOPS AND MONITOR THE ANC
MORE FREQUENTLY. (5.1)
•
ADVISE PATIENTS TAKING FERRIPROX TO REPORT IMMEDIATELY ANY
SYMPTOMS INDICATIVE OF INFECTION. (5.1)
-----------------------------
INDICATIONS AND USAGE
--------------------------
FERRIPROX is indicated for the treatment of iron overload in patients
with
thalassemia major when deferoxamine therapy is contra-indicated or
inadequate.
------------------------
DOSAGE AND ADMINISTRATION
----------------------
•
Starting oral dosage: 75 mg/kg/day (actual body weight) in two divided
doses (2.2)
•
Maximum oral dosage: 99 mg/kg/day (actual body weight) in two divided
doses (2.2)
-----------------------
DOSAGE FORMS AND STRENGTHS
--------------------
•
Delayed-release tablets: 1000 mg with functional scoring (3)
------------------------------
CONTRAINDICATIONS
-------------------------------
Hypersensitivity to deferiprone or to any of the excipients in the
formulations.
(4)
------------------------
WARNINGS AND PRECAUTIONS
-----------------------
•
Liver Enzyme Elevations: Monitor monthly and discontinue for
persistent elevations. (5.2)
•
Zinc Deficiency: Monitor during therapy and supplement for deficiency.
(5.3)
•
Embryo-Fetal Toxicity: Can cause fetal harm. (5.4)
-------------------