Imatinib Mylan 100mg film-coated tablets

Nazione: Malta

Lingua: inglese

Fonte: Medicines Authority

Principio attivo:

IMATINIB

Commercializzato da:

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

Codice ATC:

L01XE01

INN (Nome Internazionale):

IMATINIB 100 mg

Forma farmaceutica:

FILM-COATED TABLET

Composizione:

IMATINIB 100 mg

Tipo di ricetta:

POM

Area terapeutica:

ANTINEOPLASTIC AGENTS

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

2016-10-14

Foglio illustrativo

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
IMATINIB MYLAN 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 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 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
in

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Imatinib Mylan 100 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 100 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, round shaped, film-coated tablets of
10.1 mm (± 5%) diameter with a break-
line on one side and ‘100’ 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.
•
a
dult patients with advanced hypereosinophilic syndrome (HES) and/or
chronic eosinophilic leukaemia
(CEL) with FIP1L1-PDGFRα rearrangement.
The effect of imatinib on the outcome of bone marrow transplantation
has not been determined.
Imatinib is indicated for
•
the treatment of adult patients with Kit (CD 117) positive
unresectable and/or metastatic malignant
gastrointestinal stromal tumours (GIST).
•
the adjuvant treatment of adult patients who are at significant risk
of relapse following resection of Kit
(CD117)-positive GIST. Patients who have a low or very low risk of
recurrence should not receive
adjuvant treatment.
•
the treatment of a