Imatinib Siegfried 100mg film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

IMATINIB

Available from:

hameln rds GmbH Langes Feld 13, 31789 Hameln, Germany

ATC code:

L01XE01

INN (International Name):

IMATINIB 100 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

IMATINIB 100 mg

Prescription type:

POM

Therapeutic area:

ANTINEOPLASTIC AGENTS

Authorization status:

Withdrawn

Authorization date:

2014-05-05

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
Imatinib Siegfried 100 mg film-coated tablets
Imatinib
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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes
any possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Imatinib Siegfried is and what it is used for
2.
What you need to know before you take Imatinib Siegfried
3.
How to take Imatinib Siegfried
4.
Possible side effects
5.
How to store Imatinib Siegfried
6.
Contents of the pack and other information
1.
WHAT IMATINIB SIEGFRIED IS AND WHAT IT IS USED FOR
Imatinib Siegfried is a medicine containing an active substance called
imatinib. This
medicine works by inhibiting the growth of abnormal cells in the
diseases listed below.
These include some types of cancer.
IMATINIB SIEGFRIED IS A TREATMENT FOR ADULTS AND CHILDREN FOR:
−
CHRONIC MYELOID LEUKAEMIA (CML).
Leukaemia is a cancer of white blood cells.
These
white
cells
usually
help
the
body
to
fight
infection.
Chronic
myeloid
leukaemia is a form of leukaemia in which certain abnormal white cells
(named
myeloid cells) start growing out of control.
In adult patients Imatinib Siegfried is used to treat a late stage of
Chronic Myeloid
Leukaemia called “blast crisis.” In children and adolescents
however it may be used
to treat all stages of the illness.
−
PHILADELPHIA CHROMOSOME POSITIVE ACUTE LYMPHOBLASTIC LEUKAEMIA
(PH-POSITIVE
ALL)
. Leukaemia is a cancer of white blood cells. These white cells
usually help
the body to fight infection. Acute lymphoblastic leukaemia is a form
of leukaemia
in which certain abnormal white cells (named lymphobla

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Imatinib Siegfried 100 mg film-coated tablets
Imatinib Siegfried 400 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Imatinib Siegfried 100 mg film-coated tablets:
Each film-coated tablet contains 100 mg imatinib (as mesilate).
Imatinib Siegfried 400 mg film-coated tablets:
Each film-coated tablet contains 400 mg imatinib (as mesilate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Imatinib Siegfried 100 mg film-coated tablets are round tablets with
light brown film
coating and a diameter of 8 mm, score on one side, debossed with
“IM” on the same
side and with “100” on the other side.
Imatinib Siegfried 400 mg film-coated tablets are oval tablets with
light brown film
coating, 17 mm long and 8 mm wide, score on both sides, debossed with
“IM” on one
side and with “400” on the other side.
The tablets can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Imatinib Siegfried is indicated for the treatment of

paediatric patients with newly diagnosed Philadelphia chromosome
(bcr-abl)
positive (Ph+) chronic myeloid leukaemia (CML) for whom bone marrow
transplantation is not considered as the first line of treatment.

paediatric patients with Ph+ CML in chronic phase after failure of
interferon-
alpha therapy, or in accelerated phase or blast crisis.

adult patients with Ph+ CML in blast crisis.

adult and paediatric patients with newly diagnosed Philadelphia
chromosome
positive
acute
lymphoblastic
leukaemia
(Ph+
ALL)
integrated
with
chemotherapy.

adult patients with relapsed or refractory Ph+ ALL as monotherapy.

adult patients with myelodysplastic/myeloproliferative diseases
(MDS/MPD)
associated
with
platelet-derived
growth
factor
receptor
(PDGFR)
gene
re-
arrangements.

adult patients with advanced hypereosinophilic syndrome (HES) and/or
chronic
eosinophilic leukaemia (CEL) with FIP1L1-PDGFRα rearrangement.
The effect