GEFITINIB intega (Gefitinib 250mg Film-Coated Tablets)

Country: Malaysia

Language: English

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

Active ingredient:

Gefitinib

Available from:

Intega Sdn. Bhd.

INN (International Name):

Gefitinib

Units in package:

30 Tablets

Manufactured by:

Remedica Ltd.

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
GEFITINIB INTEGA FILM-COATED TABLETS
Gefitinib (250mg)
WHAT IS IN THIS LEAFLET
1.
What
_GEFITINIB intega_
is
used for
2.
How
_GEFITINIB intega_
works
3.
Before you use
_GEFITINIB _
_intega_
4.
How to use
_GEFITINIB _
_intega_
5.
While you are using it
6.
Side effects
7.
Storage & Disposal of
_GEFITINIB intega_
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT _GEFITINIB INTEGA_ IS USED
FOR
_GEFITINIB intega_
is used to treat
advanced non-small cell lung
cancer, which is one type of lung
cancer.
HOW _GEFITINIB INTEGA_ WORKS
_GEFITINIB intega_
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 _GEFITINIB _
_INTEGA_
-
_When you must not use it _
Do not take
_GEFITINIB intega_
if
you are allergic to gefitinib or any
of the other ingredients of
_GEFITINIB intega_
, listed at the
end of this leaflet. If you think you
may be allergic, ask your doctor
for advice.
_GEFITINIB intega_
is not
recommended for use in children
or adolescents.
-
_Before you start to use it _
Before taking
_GEFITINIB intega_
:
•
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
_GEFITINIB intega_
.
•
Tell your doctor if you are
pregnant or trying to
become pregnant. You
should avoid becoming
pregnant during treatment
with
_GEFITINIB intega_
.
•
Tell your doctor if you are
breast-feeding. For the
safety
of your baby, you should
discontinue breast-feeding
during treatment with
_GEFITINIB intega_
.
-
_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’

Summary of Product characteristics

1(8)
GEFITINIB INTEGA (GEFITINIB 250MG FILM-COATED
TABLETS)
PRESENTATION
Brown, round, biconvex, film-coated tablet impressed with “250” on
one side and plain
on the other. Each tablet contains 250 mg gefitinib.
INDICATIONS
_GEFITINIB intega_
is indicated for the treatment of adult patients with locally advanced
or metastatic non-small cell lung cancer (NSCLC) with activating
mutations of EGFR-
TK.
DOSAGE AND ADMINISTRATION
The recommended dose of
_GEFITINIB intega_
is one 250 mg tablet once a day, taken with
or without food. If a dose of
_GEFITINIB intega_
is missed, it should be taken as soon as
the patient remembers. If it is less than 12 hours to the next dose,
the patient should not
take the missed dose. Patients should not take a double dose (two
doses at the same time)
to make up for a forgotten dose.
Where dosing of whole tablets is not possible, such as patients who
are only able to
swallow liquids, tablets may be administered as a dispersion in water.
The tablet should
be dropped into half a glass of drinking water (non-carbonated),
without crushing, and
the glass stirred until the tablet has dispersed (approximately 15
minutes) and the contents
subsequently drunk immediately. The glass should be rinsed with a
further half glass of
water and the contents drunk. The liquid can also be administered via
a nasogastric tube.
_GEFITINIB intega_
is not recommended for use in children or adolescents as safety and
effectiveness in these patient populations has not been studied.
No dosage adjustment is required on the basis of patient age, body
weight, gender,
ethnicity,or renal function or in patients with moderate to severe
hepatic impairment due
to liver metastases.
DOSAGE ADJUSTMENT:
Patients with poorly tolerated diarrhoea or skin adverse drug
reactions may be successfully managed by providing a brief (up to 14
days) therapy
interruption followed by reinstatement of the 250 mg dose.
2(8)
CONTRAINDICATIONS
Known severe hypersensitivity to the active substance or to any of the
excipients of this
product.
W