Glivec 100mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Imatinib mesilate

Available from:

Novartis Pharmaceuticals UK Ltd

ATC code:

L01XE01

INN (International Name):

Imatinib mesilate

Dosage:

100mg

Pharmaceutical form:

Tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 08010500; GTIN: 5010678907063

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
GLIVEC
® 100 MG FILM-COATED TABLETS
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 the end of section 4
for how to report side effects
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 Glivec is and what it is used for
2.
What you need to know before you take Glivec
3.
How to take Glivec
4.
Possible side effects
5.
How to store Glivec
6.
Contents of the pack and other information
1.
WHAT GLIVEC IS AND WHAT IT IS USED FOR
Glivec 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.
GLIVEC 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. Glivec
inhibits the growth of
these cells.
GL

Summary of Product characteristics

OBJECT 1
GLIVEC 400 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 03-May-2018 | Novartis
Pharmaceuticals UK Ltd
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
Glivec
®
100 mg film-coated tablets
Glivec
®
400 mg film-coated tablets
2. Qualitative and quantitative composition
Glivec 100 mg film-coated tablets
Each film-coated tablet contains 100 mg imatinib (as mesilate).
Glivec 400 mg film-coated tablets
Each film-coated tablet contains 400 mg imatinib (as mesilate).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet
Glivec 100 mg film-coated tablets
Very dark yellow to brownish-orange film-coated tablet, round with
“NVR” on one side and “SA” and
score on the other side.
Glivec 400 mg film-coated tablets
Very dark yellow to brownish-orange, ovaloid, biconvex film-coated
tablet with bevelled edges, debossed
with “glivec” on one side.
4. Clinical particulars
4.1 Therapeutic indications
Glivec 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 advanc