Iressa 250mg Film-coated Tablet

Ülke: Malezya

Dil: İngilizce

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

Aktif bileşen:

Gefitinib

Mevcut itibaren:

ASTRAZENECA SDN. BHD.

INN (International Adı):

Gefitinib

Paketteki üniteler:

30 Tablets

Tarafından üretildi:

Kagamiishi Plant, Nipro Pharma Corporation

Bilgilendirme broşürü

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

Ürün özellikleri

IRESSA
® 250MG FILM-COATED TABLET
TRADE MARK
PRESENTATION
Brown, round, biconvex, film-coated tablet impressed with “IRESSA
250” on one
side and plain on the other. Each tablet contains 250 mg gefitinib.
INDICATIONS
IRESSA 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 (see ‘WARNINGS AND PRECAUTIONS’ section).
DOSAGE AND ADMINISTRATION
The recommended dose of IRESSA is one 250 mg tablet once a day, taken
with or
without food. If a dose of IRESSA 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.
IRESSA 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 (see ‘PHARMACOKINETIC PROPERTIES’
section).
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
(see
‘POSSIBLE
ADVERSE REACTIONS’ section).
CONTRAINDICATIONS
Known severe hypersen