Deferasirox Teva 500 mg Dispergerbar tablett

Country: Sweden

Language: Swedish

Source: Läkemedelsverket (Medical Products Agency)

Active ingredient:

deferasirox

Available from:

Teva Sweden AB

ATC code:

V03AC03

INN (International Name):

deferasirox

Dosage:

500 mg

Pharmaceutical form:

Dispergerbar tablett

Composition:

laktosmonohydrat Hjälpämne; deferasirox 500 mg Aktiv substans; natriumlaurilsulfat Hjälpämne

Prescription type:

Receptbelagt

Product summary:

Förpacknings: Blister, 28 tabletter; Blister, 30 tabletter; Blister, 84 tabletter; Blister, 98 tabletter; Blister, 28 x 1 tabletter (endos); Blister, 30 x 1 tabletter (endos); Blister, 84 x 1 tabletter (endos); Blister, 98 x 1 tabletter (endos); Blister, 294 (3 x 98) tabletter

Authorization status:

Godkänd

Authorization date:

2017-09-29

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DEFERASIROX TEVA 125 MG DISPERSIBLE TABLETS
DEFERASIROX TEVA 250 MG DISPERSIBLE TABLETS
DEFERASIROX TEVA 500 MG DISPERSIBLE TABLETS
deferasirox
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 only for you or your child. 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.
WHAT IS IN THIS LEAFLET
1.
What is and what it is used for
2.
What you need to know before you take
3.
How to take
4.
Possible side effects
5.
How to store
6.
Contents of the pack and other information
1.
WHAT IS AND WHAT IT IS USED FOR
WHAT IS
contains an active substance called deferasirox. It is
an iron chelator which is a
medicine used to remove the excess iron from the body (also called
iron overload). It traps and
removes excess iron which is then excreted mainly in the stools.
WHAT IS USED FOR
Repeated blood transfusions may be necessary in patients with various
types of anaemia (for example
thalassaemia, sickle cell disease or myelodysplastic syndromes (MDS)).
However, repeated blood
transfusions can cause a build-up of excess iron. This is because
blood contains iron and your body
does not have a natural way to remove the excess iron you get with
your blood transfusions. In
patients with non-transfusion-dependent thalassaemia syndromes, iron
overload may also develop over
time, mainly due to increased absorption of dietary iron in response
to low blood cell counts. Over
time, the excess iron can damage important organs such as the liver
and heart. Medi

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
Deferasirox, SE/H/1885/001-003, 01.10.2018
reduction of shelf life from 36 months to 24 months
2
1.
NAME OF THE MEDICINAL PRODUCT
Deferasirox Teva 125 mg dispersible tablets
Deferasirox Teva 250 mg dispersible tablets
Deferasirox Teva 500 mg dispersible tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dispersible tablet contains 125 mg of deferasirox.
Each dispersible tablet contains 250 mg of deferasirox.
Each dispersible tablet contains 500 mg of deferasirox.
Excipient with known effect
Each dispersible tablet contains 85 mg lactose monohydrate.
Each dispersible tablet contains 171mg lactose monohydrate.
Each dispersible tablet contains 341 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Dispersible tablet
125 mg dispersible tablets
White to off-white, round, flat tablets with bevelled edges and
debossing 77 on one side and 438 on
the other side. Diameter of each tablet is approx. 12 mm.
250 mg dispersible tablets
White to off-white, round, flat tablets with bevelled edges and
debossing 77 on one side and 439 on
the other side. Diameter of each tablet is approx. 15 mm.
500 mg dispersible tablets
White to off-white, round, flat tablets with bevelled edges and
debossing 77 on one side and 440 on
the other side. Diameter of each tablet is approx. 20 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
is indicated for the treatment of chronic iron overload
due to frequent blood
transfusions (≥7 ml/kg/month of packed red blood cells) in patients
with beta thalassaemia major aged
6 years and older.
is also indicated for the treatment of chronic iron
overload due to blood transfusions
when deferoxamine therapy is contraindicated or inadequate in the
following patient groups:
-
in paediatric patients with beta thalassaemia major with iron overload
due to frequent blood
transfusions (≥7 ml/kg/month of packed red blood cells) aged 2 to 5
years,
-
in adult and paediatric patients with beta th