Imatinib Clonmel 100 mg Film-coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Imatinib

Available from:

Clonmel Healthcare Ltd

ATC code:

L01X

INN (International Name):

Imatinib

Dosage:

100 milligram(s)

Pharmaceutical form:

Film-coated tablet

Administration route:

oral use

Units in package:

: 1x 60 tablets, 1x 90, 120 (2x 60 tablets), 180 (3x 60 tablets)

Prescription type:

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

Manufactured by:

S.C. POLIPHARMA INDUSTRIES

Therapeutic group:

antineoplastic agents, protein kinase inhibitor

Therapeutic area:

OTHER ANTINEOPLASTIC AGENTS

Therapeutic indications:

Imatinib Clonmel is indicated in:
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.
paediatric patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis.
adult patients with Ph+ CML in blast crisis
adult 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 hypereosino

Authorization status:

Marketed

Authorization date:

2015-10-02

Patient Information leaflet

Page 1 of 8
PACKAGE LEAFLET: INFORMATION FOR THE USER
IMATINIB CLONMEL 100MG FILM-COATED TABLETS
IMATINIB CLONMEL 400MG 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 Clonmel is and what it is used for
2.
What you need to know before you take Imatinib Clonmel
3.
How to take Imatinib Clonmel
4.
Possible side effects
5.
How to store Imatinib Clonmel
6.
Contents of the pack and other information
1.
WHAT IMATINIB CLONMEL IS AND WHAT IT IS USED FOR
Imatinib Clonmel 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 CLONMEL 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
Clonmel inhibits the growth of
these cells.
IMATINIB CLONMEL IS ALSO A TREATMENT FOR ADULTS FOR:
-
MYELODYSPLASTIC/MYELOPROLIFERATIVE

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Imatinib Clonmel 100 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 100 mg imatinib (as mesylate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Brownish , round, biconvex, film-coated tablets embossed with "100" on
one side and a score line on the other side,
with "N" on one side of the score line and "I" on the other side of
the score line.
Thickness: approx. 2.9-3.5 mm
Diameter: approx. 6.9-7.3 mm
The tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Imatinib Clonmel 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 Clonmel 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 cytogenet