Imatinib Mylan 400mg film-coated tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

IMATINIB

Available from:

Mylan Ireland Limited Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland

ATC code:

L01EA

INN (International Name):

IMATINIB 400 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

IMATINIB 400 mg

Prescription type:

POM

Therapeutic area:

ANTINEOPLASTIC AGENTS

Authorization status:

Withdrawn

Authorization date:

2016-10-14

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
IMATINIB MYLAN 400 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 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, 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 Mylan is and what it is used for
2.
What you need to know before you take Imatinib Mylan
3.
How to take Imatinib Mylan
4.
Possible side effects
5.
How to store Imatinib Mylan
6.
Contents of the pack and other information
1.
WHAT IMATINIB MYLAN IS AND WHAT IT IS USED FOR
Imatinib Mylan 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 MYLAN 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.
•
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 lymphoblasts) start growing out of control.
Imatinib Mylan inhibits the
growth of these cells.
IMATINIB IS ALSO A TREATMENT FOR ADULTS FOR
•
MYELODYSPLASTIC/MYELOPROLIFERATIVE DISEASES (MDS/MPD).
These are a group of blood
diseases
i

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Imatinib Mylan 400 mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 400 mg imatinib (as imatinib
mesilate).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet
Dark yellow to brownish-orange, ovaloid shaped, film-coated tablets,
21.6 mm long &
10.6mm wide (± 5%) with a break-line on one side and ‘400’ on the
other side. The tablet
can be divided into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Imatinib Mylan is indicated for the treatment of
•
adult
and
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.
•
adult and paediatric patients with Ph+ CML in chronic phase after
failure of
interferon-alpha therapy, or in accelerated phase or 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-PDGFR rearrangement.
The effect of Imatinib Mylan on the outcome of bone marrow
transplantation has not been
determined.
Imatinib Mylan is indicated for:
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•
the
treatment
of
adult
patients
with
unresectable
dermatofibrosarcoma
protuberans (DFSP) and adult patients with recurrent and/or metastatic
DFSP who are not eligible for surgery.
In
adult
and
paediatric
patients,
the
effectiveness
of
imatinib
is
based
on
overall
haematological and cytogenetic response rates and progression-free
survival in CML, on