Imatinib 400 mg film-coated tablets

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

Imatinib

Dostępny od:

Generics (UK) Limited

INN (International Nazwa):

Imatinib

Dawkowanie:

400 milligram(s)

Forma farmaceutyczna:

Film-coated tablet

Typ recepty:

Product subject to prescription which may not be renewed (A)

Status autoryzacji:

Not marketed

Data autoryzacji:

2016-07-22

Ulotka dla pacjenta

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
IMATINIB 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 is and what it is used for
2.
What you need to know before you take Imatinib
3.
How to take Imatinib
4.
Possible side effects
5.
How to store Imatinib
6.
Contents of the pack and other information
1.
WHAT IMATINIB IS AND WHAT IT IS USED FOR
Imatinib 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 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
which some blood cells start growing out of control. Imatinib in

Charakterystyka produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Imatinib 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 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 on the outcome of bone marrow transplantation
has not been determined.
Imatinib is indicated for
• 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 response rates in Ph