Gefticip 250 (Gefitinib Tablets 250 mg)

Nchi: Malesia

Lugha: Kiingereza

Chanzo: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Viambatanisho vya kazi:

Gefitinib

Inapatikana kutoka:

CIPLA MALAYSIA SDN BHD

INN (Jina la Kimataifa):

Gefitinib

Vitengo katika mfuko:

3 x 10 Tablets

Viwandani na:

CIPLA LTD

Taarifa za kipeperushi

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
GEFTICIP 250 (GEFITINIB TABLETS 250 MG)
GEFITINIB (250MG)_ _
1
WHAT IS IN THIS LEAFLET
1.
What Gefticip is used for
2.
How Gefticip works
3.
Before you use Gefticip
4.
How to use Gefticip
5.
While you are using it
6.
Side effects
7.
Storage & Disposal of Gefticip
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
11.
Serial Number
WHAT GEFTICIP IS USED FOR
Gefticip is used to treat advanced
non-small cell lung cancer, which is
one type of lung cancer.
HOW GEFTICIP WORKS
Gefticip contains the active
substance gefitinib which blocks a
protein called ‘epidermal growth
factor receptor’ (EGFR). This
protein is involved in the growth
and spread of cancer cells.
BEFORE YOU USE GEFTICIP
-
_When you must not use it _
Do not take Gefticip if you are
allergic to gefitinib or any of the
other ingredients of Gefticip,
listed at the end of this leaflet. If
you think you may be allergic,
ask your doctor for advice.
Gefticip is not recommended for use
in children or adolescents.
-
_Before you start to use it _
Before taking Gefticip:
•
Tell your doctor if you have or
have had any other lung diseases,
other than your lung cancer. Some
of them may worsen during
treatment with Gefticip.
•
Tell your doctor if you are pregnant
or trying to become pregnant. You
should avoid becoming pregnant
during treatment with Gefticip.
•
Tell your doctor if you are breast-
feeding. For the safety of your baby,
you should discontinue breast-
feeding during treatment with
Gefticip.
-
_Taking other medicines _
PLEASE INFORM YOUR DOCTOR
if you
are taking or have taken any
medicines (including medicines
taken some time ago), even those
not prescribed. Your doctor
especially needs to know:
•
if you take any of the following
medicines: phenytoin,
carbamazepine, rifampicin,
barbiturates, St John’s Wort or
itraconazole, or any medicines
that reduce the acidity on your
stomach, such as ranitidine.
These medicines may affect the
way Gefticip works.
•
i

Tabia za bidhaa

_For the use of a Registered Medical Practitioner or a Hospital or a
Laboratory only _
_OR_
_for Specialist Use _
_only_
GEFTICIP
250
Gefitinib Tablets 250
mg
COMPOSITION
Each film coated tablet
contains:
Gefitinib BP/Ph. Eur …250
mg
Colour – Titanium dioxide, Iron Oxide Red and Iron oxide
Yellow
Excipient with known effect: Lactose
DOSAGE FORM
Tablet
PRODUCT DESCRIPTION
Round, biconvex, brown, film coated tablets debossed with “C” on
one side and plain on the
other side.
PHARMACOLOGY
_PHARMACODYNAMICS _
ATC
Classification
_ _
L01XE02 - gefitinib; Belongs to the class of protein kinase
inhibitors,
other
antineoplastic agents. Used in the treatment of
cancer.
Gefitinib is a selective inhibitor of the epidermal growth factor
receptor (EGFR)
tyrosine
kinase,
commonly expressed in solid human tumours of epithelial origin.
Inhibition
of
EGFR tyrosine
kinase activity inhibits tumour growth, metastasis and angiogenesis
and
increases tumour cell
apoptosis.
Patients that have never smoked, have adenocarcinoma histology, are
female gender
or
are of
Asian
ethnicity,
are
more
like
to
benefit
from
treatment with
gefitinib.
These
clinical
characteristics are also associated with a higher rate of EGFR
mutation
positive tumours.
_PHARMACOKINETICS_
Following intravenous administration, gefitinib is rapidly cleared,
extensively
distributed
and has
a mean elimination half-life of 48 hours. Following oral dosing in
cancer
patients, absorption is
moderately slow and the mean terminal half-life is 41
hours.
Administration
of gefitinib once
daily results in 2 to 8-fold accumulation
with
steady
state exposures achieved after 7 to 10
doses. At steady state, circulating
plasma
concentrations are typically maintained within a 2 to 3-
fold range over the
24-hour
dosing
interval.
Absorption
Following oral administration of gefitinib, peak plasma
concentrations
of
gefitinib
typically
occur at 3 to 7 hours after dosing. Mean absolute bioavailability is
59%
in
cancer patients.
Exposure to gefitinib is not significantly altered by food.