Deferiprone Lipomed

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

Deferiprone

Saatavilla:

Lipomed GmbH

ATC-koodi:

V03AC02

INN (Kansainvälinen yleisnimi):

deferiprone

Terapeuttinen ryhmä:

All other therapeutic products

Terapeuttinen alue:

Iron Overload; beta-Thalassemia

Käyttöaiheet:

Deferiprone Lipomed monotherapy is indicated for the treatment of iron overload in patients with thalassaemia major when current chelation therapy is contraindicated or inadequate.Deferiprone Lipomed 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 justifies rapid or intensive correction.

Tuoteyhteenveto:

Revision: 7

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2018-09-19

Pakkausseloste

22
B. PACKAGE LEAFLET
23
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DEFERIPRONE LIPOMED 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.
-
Provided in the folding box, you will find a patient card. You should
complete and read the card
carefully and carry it with you. Provide this 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 Deferiprone Lipomed is and what it is used for
2.
What you need to know before you take Deferipone Lipomed
3.
How to take Deferiprone Lipomed
4.
Possible side effects
5.
How to store Deferiprone Lipomed
6.
Contents of the pack and other information
1.
WHAT DEFERIPRONE LIPOMED IS AND WHAT IT IS USED FOR
Deferiprone Lipomed contains the active substance deferiprone.
Deferiprone Lipomed is an iron
chelator, a type of medicine that removes excess iron from the body.
Deferiprone Lipomed 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 DEFERIPRONE LIPOMED
DO NOT TAKE DEFERIPRONE LIPOMED
-
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

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Deferiprone Lipomed 500 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 500 mg deferiprone.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
White to off-white, glossy surface, oval film-coated tablet. The
tablet is 8.2 mm x 17.2 mm x 6.7 mm
and scored. The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Deferiprone Lipomed monotherapy is indicated for the treatment of iron
overload in patients with
thalassaemia major when current chelation therapy is contraindicated
or inadequate.
Deferiprone Lipomed 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.
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 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 DEFERIPRONE LIPOMED 500 MG FILM-COATED TABLETS_
BODY WEIGHT
(KG)
TOTAL DAILY DOSE
(MG)
DOSE
(MG, THREE TIMES/DAY)
NUMBER OF TABLETS
(THREE TIMES/DAY)
20
1 500
500
1.0
30
2 250
750
1.5
40
3 000
1 000
2.0
50
3 750
1 250
2.5
60
4 500
1 500
3.0
70
5 250
1 750
3.5
80
6 000
2 000
4.0
90
6 750
2 250
4.5
3
A total daily dose above