Imatinib 100mg capsules, hard

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

IMATINIB MESILATE

Available from:

Cipla (EU) Limited Hillbrow House, Hillbrow Road, Esher, Surrey, KT10 9NW, United Kingdom

ATC code:

L01XE01

INN (International Name):

IMATINIB MESILATE 100 mg

Pharmaceutical form:

HARD CAPSULE

Composition:

IMATINIB MESILATE 100 mg

Prescription type:

POM

Therapeutic area:

ANTINEOPLASTIC AGENTS

Authorization status:

Withdrawn

Authorization date:

2015-06-08

Patient Information leaflet

Page 1 of 10
PACKAGE LEAFLET – INFORMATION FOR THE PATIENT
IMATINIB 100MG CAPSULES, HARD
imatinib This medicine is subject to additional monitoring. This will allow
quick identification of new safety
information. You can help by reporting any side effects you may get.
See section 4 for how to report
adverse reactions
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 capsules is and what it is used for
2.
What you need to know before you take imatinib capsules
3.
How to take imatinib capsules
4.
Possible side effects
5.
How to store imatinib capsules
6.
Contents of the pack and other information
1.
WHAT IMATINIB CAPSULES IS AND WHAT IT IS USED FOR
Imatinib capsule 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.
In adult patients imatinib is used to treat a late stage of Chronic
Myeloid Leukaemia called “blast
crisis”. In children and adolescents however it may be used to treat
all stages of the illness.
-
PHILADELPHIA CHROMOSOME POSITIVE ACUTE LYMPHOBLASTIC LEUKAEMIA
(PH-POSITIVE ALL).
Leukaemia is a canc

Summary of Product characteristics

Page 1 of 48
SUMMARY OF PRODUCT CHARACTERISTICS
This medicinal product is subject to additional monitoring. This will
allow quick
identification of new safety information. Healthcare professionals are
asked to report any
suspected adverse reactions. See section 4.8 for how to report adverse
reactions
1.
NAME OF THE MEDICINAL PRODUCT
Imatinib 100mg capsules, hard
Imatinib 400mg capsules, hard
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard gelatin capsule contains 100mg imatinib (as mesilate)
Each hard gelatin capsule contains 400mg imatinib (as mesilate).
EXCIPIENT WITH KNOWN EFFECTS:
Each 100mg capsules contains 40 mg of lactose anhydrous.
Each 400mg capsules contains 160 mg of lactose anhydrous.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule, hard
100mg:
Hard capsule are light yellow granules filled in size “3” hard
gelatin capsule with brown
cap and white body.
Capsule length: 15.8 mm
400mg:
Hard capsule are light yellow granules filled in size “00EL” hard
gelatin capsule with
brown cap and brown body.
Page 2 of 48
Capsule length: 25.5 mm
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Imatinib is indicated for the treatment of

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 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 sy