Imatinib Mylan Tablet, film coated 400mg

Kraj: Malta

Język: angielski

Źródło: Medicines Authority

Składnik aktywny:

IMATINIB

Dostępny od:

Generics UK Limited

Kod ATC:

L01XE01

INN (International Nazwa):

IMATINIB

Forma farmaceutyczna:

FILM-COATED TABLET

Skład:

IMATINIB 400 mg

Typ recepty:

POM

Dziedzina terapeutyczna:

ANTINEOPLASTIC AGENTS

Status autoryzacji:

Authorised

Ulotka dla pacjenta

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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 WITH 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 Mylan 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.
IMATINIB MYLAN IS ALSO A TREATMENT FOR ADULTS FOR:

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
w

Charakterystyka produktu

Page 1 of 29
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

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 with Ph+ CML in blast crisis.

adult
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 Imatinb Mylan on the outcome of bone marrow
transplantation has not been
determined.
Page 2 of 29
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
haematological and cytogenetic re