Ferriprox

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

Deferiprone

Saatavilla:

Chiesi Farmaceutici S.p.A.

ATC-koodi:

V03AC02

INN (Kansainvälinen yleisnimi):

deferiprone

Terapeuttinen ryhmä:

All other therapeutic products

Terapeuttinen alue:

beta-Thalassemia; Iron Overload

Käyttöaiheet:

Ferriprox monotherapy is indicated for the treatment of iron overload in patients with thalassaemia major when current chelation therapy is contraindicated or inadequate.Ferriprox in combination with another chelator is indicated in patients with thalassaemia major when monotherapy with any iron chelator is ineffective, or when prevention or treatment of life-threatening consequences of iron overload (mainly cardiac overload) justifies rapid or intensive correction.

Tuoteyhteenveto:

Revision: 32

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

1999-08-25

Pakkausseloste

44
B. PACKAGE LEAFLET
45
PACKAGE LEAFLET: INFORMATION FOR THE USER
FERRIPROX 500 MG FILM-COATED TABLETS
deferiprone
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
−
Keep this leaflet. You may need to read it again.
−
If you have any further questions, ask your doctor or pharmacist.
−
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
−
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
−
A patient card is attached to the carton. You should detach, complete,
read the patient card
carefully and carry it with you. Provide this patient card to your
doctor if you develop infection
symptoms such as a fever, sore throat or flu-like symptoms.
WHAT IS IN THIS LEAFLET
1.
What Ferriprox is and what it is used for
2.
What you need to know before you take Ferriprox
3.
How to take Ferriprox
4.
Possible side effects
5.
How to store Ferriprox
6.
Contents of the pack and other information
1.
WHAT FERRIPROX IS AND WHAT IT IS USED FOR
Ferriprox contains the active substance deferiprone. Ferriprox is an
iron chelator, a type of medicine
that removes excess iron from the body.
Ferriprox is used to treat iron overload caused by frequent blood
transfusions in patients with
thalassaemia major when current chelation therapy is contraindicated
or inadequate.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE FERRIPROX
DO NOT TAKE FERRIPROX
−
if you are allergic to deferiprone or any of the other ingredients of
this medicine (listed in
section 6).
−
if you have a history of repeated episodes of neutropenia (low white
blood cell (neutrophil)
count).
−
if you have a history of agranulocytosis (very low white blood cell
(neutrophil) count).
−
if you are currently taking medicines known to cause neutropenia or
agranulocytosis (see “Other
medicines and Ferriprox”).
�

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Ferriprox 500 mg film-coated tablets
Ferriprox 1 000 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ferriprox 500 mg film-coated tablets
Each tablet contains 500 mg deferiprone.
Ferriprox 1 000 mg film-coated tablets
Each tablet contains 1 000 mg deferiprone.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Ferriprox 500 mg film-coated tablets
White to off-white, capsule-shaped, film-coated tablet imprinted
“APO” bisect “500” on one side,
plain on the other. The tablet is 7.1 mm x 17.5 mm x 6.8 mm and
scored. The tablet can be divided
into equal halves.
Ferriprox 1 000 mg film-coated tablets
White to off-white, capsule-shaped, film-coated tablet imprinted
“APO” bisect “1000” on one side,
plain on the other. The tablet is 7.9 mm x 19.1 mm x 7 mm and scored.
The tablet can be divided into
equal halves.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ferriprox monotherapy is indicated for the treatment of iron overload
in patients with thalassaemia
major when current chelation therapy is contraindicated or inadequate.
Ferriprox in combination with another chelator (see section 4.4) is
indicated in patients with
thalassaemia major when monotherapy with any iron chelator is
ineffective, or when prevention or
treatment of life-threatening consequences of iron overload (mainly
cardiac overload) justifies rapid or
intensive correction (see section 4.2).
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.
3
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 tables below for recommended doses for body weights at 10
kg increments.
To obtain a dose of about 75 mg/kg/day, use the n