Imatinib Rowex 400mg Film-coated tablets

Country: Մալթա

language: անգլերեն

source: Medicines Authority

active_ingredient:

IMATINIB MESILATE

MAH:

Rowex Ltd Newtown Bantry, Co. Cork, , Ireland

ATC_code:

L01EA

INN:

IMATINIB MESILATE 400 mg

pharmaceutical_form:

FILM-COATED TABLET

composition:

IMATINIB MESILATE 400 mg

prescription_type:

POM

therapeutic_area:

ANTINEOPLASTIC AGENTS

leaflet_short:

Licence number in the source country: NOT APPLICAPABLE

authorization_status:

Withdrawn

authorization_date:

2021-01-28

PIL

Page 1 of 10
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
IMATINIB ROWEX 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 Rowex is and what it is used for
2. What you need to know before you take Imatinib Rowex
3. How to take Imatinib Rowex
4. Possible side effects
5. How to store Imatinib Rowex
6. Contents of the pack and other information
1. WHAT IMATINIB ROWEX IS AND WHAT IT IS USED FOR
Imatinib Rowex 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 ROWEX 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 Rowex
inhibits the
growth of these cells.
IMATINIB ROWEX IS ALSO A TREATMENT FOR ADULTS FOR:
Page 2 of 10
•
MYELODYSPLASTIC/MYELOPROLIFERATIVE DISEASES (MDS/MPD)
. These are a g

SPC

Page 1 of 39
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Imatinib RowexImatinib Rowex 400 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 400 mg of imatinib (as mesilate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Very dark yellow to brownish orange, ovaloid, biconvex with bevelled
edges, debossed with “400” on
one side and score on the other side and SL on each side of the score.
Approximate length 19.2 mm
and width 7.7 mm.
The film-coated tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Imatinib Rowex 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 Rowex is indicated for
Page 2 of 39
•
the
treatment
of
adult
patients
with
Kit
(CD117)-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. Patie