Imatinib TAD 100 mg film-coated tablets

Country: Malta

Language: English

Source: Medicines Authority

Available from:

TAD Pharma GmbH Heinz-Lohmann-Strasse 5, 27472 Cuxhaven, Germany

ATC code:

L01EA01

INN (International Name):

IMATINIB MESILATE 100 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

IMATINIB MESILATE 100 mg

Prescription type:

POM

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2022-06-20

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
IMATINIB TAD 100 MG FILM-COATED TABLETS
IMATINIB TAD 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 TAD is and what it is used for
2.
What you need to know before you take Imatinib TAD
3.
How to take Imatinib TAD
4.
Possible side effects
5.
How to store Imatinib TAD
6.
Contents of the pack and other information
1.
WHAT IMATINIB TAD IS AND WHAT IT IS USED FOR
Imatinib TAD 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 TAD 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 TAD
inhibits the growth of these cells.
IMATINIB TAD IS ALSO A TREATMENT FOR ADULTS FOR:
-
MYELODYSPLASTIC/MYELOPROLIFERATIVE DISEASES (MDS/MPD).
These are a group of blood di

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Imatinib TAD 100 mg film-coated tablets
Imatinib TAD 400 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
100 mg film-coated tablets
Each film-coated tablet contains 100 mg imatinib (as mesilate).
Excipient with known effect:
Each film-coated tablet contains 114 mg lactose (as monohydrate).
400 mg film-coated tablets
Each film-coated tablet contains 400 mg imatinib (as mesilate).
Excipient with known effect:
Each film-coated tablet contains 456 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet)
100 mg: Orange-brown, round (diameter 11 mm), slightly biconvex
film-coated tablets with bevelled edges
and a score line on one side. The tablet can be divided into equal
doses.
400 mg: Orange brown, oval (dimensions: 22 mm x 9 mm), biconvex
film-coated tablets.
_ _
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Imatinib TAD 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 TAD on the outcome of bone marrow
transplantation has not been determined.
Imatinib TAD is indic