FERRIPROX TABLETS 500 MG

Nazione: Israele

Lingua: inglese

Fonte: Ministry of Health

Principio attivo:

DEFERIPRONE

Commercializzato da:

LAPIDOT MEDICAL IMPORT AND MARKETING LTD

Codice ATC:

V03AC02

Forma farmaceutica:

FILM COATED TABLETS

Composizione:

DEFERIPRONE 500 MG

Via di somministrazione:

PER OS

Tipo di ricetta:

Required

Prodotto da:

APOTEX INC., CANADA

Gruppo terapeutico:

DEFERIPRONE

Area terapeutica:

DEFERIPRONE

Indicazioni terapeutiche:

For the treatment of iron overload in patients over 6 years old with thalassaemia major when deferoxamine therapy is contraindicated or inadequate.

Data dell'autorizzazione:

2013-10-31

Foglio illustrativo

PATIENT PACKAGE INSERT IN ACCORDANCE WITH
THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed with a doctor’s prescription only
FERRIPROX
® TABLETS 500/1000 MG
Film-coated tablets
COMPOSITION:
Each film-coated tablet contains:
FERRIPROX TABLETS 500 MG
Deferiprone 500 mg
FERRIPROX TABLETS 1000 MG
Deferiprone 1000 mg
INACTIVE INGREDIENTS:
Kindly refer to section 6, Additional Information.
READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This leaflet contains concise information about the medicine. If you
have further
questions, refer to the doctor or pharmacist.
This medicine has been prescribed for the treatment of your ailment.
Do not pass it
on to others. It may harm them even if it seems to you that their
medical condition is
similar.
This medicine is not to be used in children under 6 years old.
1. WHAT IS THE MEDICINE INTENDED FOR?
Ferriprox is a medicine for the treatment of iron overload in patients
over 6 years old
who suffer from thalassemia major when deferoxamine therapy is
contraindicated or
inadequate.
THERAPEUTIC GROUP: Iron-binding agents (CHELATORS)
2. BEFORE USING THE MEDICINE:
DO NOT USE THIS MEDICINE IF:
You are pregnant and/or breastfeeding.
Children under the age of 6.
You suffer from hypersensitivity to deferiprone or to any of this
medicine’s ingredients
(see section 6).
You suffer, or have suffered in the past, from neutropenia (low white
blood cell
(neutrophil) count).
You suffer, or have suffered in the past, from agranulocytosis (very
low white blood
cell (neutrophil) count).
You are currently being treated with medicines known to cause
neutropenia or
agranulocytosis.
SPECIAL WARNINGS REGARDING THE USE OF THE MEDICINE:
The most serious side effect that may occur as a result of taking
Ferriprox is a very
low white blood cell (neutrophil) count. This condition, known as
severe neutropenia
or agranulocytosis, has occurred in 1 to 2 out of 100 people who have
taken
Ferriprox in clinical studies. Because white blood cells help to fight
in

Scheda tecnica

1
1.
NAME OF THE MEDICINAL PRODUCT
Ferriprox Tablets 500 mg
Ferriprox Tablets 1000 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ferriprox Tablets 500 mg
Each tablet contains 500 mg deferiprone.
_ _
Ferriprox Tablets 1000 mg
Each tablet contains 1000 mg deferiprone.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Ferriprox Tablets 500 mg
White to off-white, capsule-shaped, film-coated tablets imprinted
“APO” bisect “500” on one side, plain
on the other. The tablet is scored. The tablet can be divided into
equal halves.
Ferriprox Tablets 1000 mg
White to off-white, capsule-shaped, film-coated tablets imprinted
“APO” bisect “1000” on one side, plain
on the other. The tablet is scored. The tablet can be divided into
equal halves.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ferriprox is indicated for the treatment of iron overload in patients
over 6 years old with thalassaemia
major in whom deferoxamine therapy is contraindicated or inadequate.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Deferiprone therapy should be initiated and maintained by a physician
experienced in the treatment of
patients with thalassaemia.
Posology
Deferiprone is usually given as 25 mg/kg body weight, orally, three
times a day for a total daily dose of
75 mg/kg body weight. Dose per kilogram body weight should be
calculated to the nearest half tablet. See
table below for recommended doses for body weights at 10 kg
increments.
2
_Dose table_
To obtain a dose of about 75 mg/kg/day, use the number of tablets
suggested in the following tables for
the body weight of the patient. Sample body weights at 10 kg
increments are listed.
_DOSE TABLE FOR FERRIPROX TABLETS 500 MG _
BODY WEIGHT
(KG)
TOTAL DAILY DOSE
(MG)
DOSE
(MG, THREE TIMES/DAY)
NUMBER OF TABLETS
(THREE TIMES/DAY)
20
1500
500
1.0
30
2250
750
1.5
40
3000
1000
2.0
50
3750
1250
2.5
60
4500
1500
3.0
70
5250
1750
3.5
80
6000
2000
4.0
90
6750
2250
4.5
_ _
_DOSE TABLE FOR FERRIPROX TABLETS 1000 MG _
BODY WEIGHT
(KG)
TOTAL DAILY