Gefitinib Sandoz Film Coated Tablet 250mg

מדינה: מלזיה

שפה: אנגלית

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

מרכיב פעיל:

Gefitinib

זמין מ:

SANDOZ PRODUCTS MALAYSIA SDN. BHD.

INN (שם בינלאומי):

Gefitinib

יחידות באריזה:

30 Tablets; 100 Tablets; 60 Tablets

תוצרת:

Remedica Ltd.

עלון מידע

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

מאפייני מוצר

1. NAME OF THE MEDICINAL PRODUCT
Gefitinib Sandoz Film Coated Tablet 250mg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 250 mg of gefitinib.
Excipient with known effect: Each tablet contains 163.5 mg of lactose
(as monohydrate).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet.
Brown, round, biconvex, film-coated tablets impressed with "250" on
one side and plain on the other side
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Gefitinib Sandoz 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.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The recommended dose of Gefitinib Sandoz is one 250 mg tablet once a
day, taken with or without food. If a dose of
Gefitinib Sandoz 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 Sandoz 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