Imatinib 100 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Imatinib mesilate

Available from:

Fresenius Kabi Deutschland GmbH

ATC code:

L01XE; L01XE01

INN (International Name):

Imatinib mesilate

Dosage:

100 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

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

Therapeutic area:

Protein kinase inhibitors; imatinib

Authorization status:

Not marketed

Authorization date:

2016-04-08

Patient Information leaflet

UK-IE-Imatinib-PIL-V008
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
IMATINIB 100 MG FILM-COATED TABLETS
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, 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 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 film-coated tablets 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 blo

Summary of Product characteristics

Health Products Regulatory Authority
01 March 2023
CRN00D83M
Page 1 of 26
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Imatinib 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
Imatinib 100mg tablets:
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 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-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 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 pr