Xeloda® Tablets 500MG

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

CAPECITABINE

Boleh didapati daripada:

DKSH MALAYSIA SDN. BHD.

INN (Nama Antarabangsa):

CAPECITABINE

Unit dalam pakej:

120 Tablets

Dikeluarkan oleh:

Excella GmbH & Co.KG

Risalah maklumat

_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
XELODA
®
TABLET
_ _
_Capecitabine (150mg, 500mg) _
_ _
_ _
1
WHAT IS IN THIS LEAFLET
1.
What Xeloda is used for
2.
How Xeloda works
3.
Before you use Xeloda
4.
How to use Xeloda
5.
While you are using it
6.
Side effects
7.
Storage and disposal of Xeloda
8.
Product description
9.
Manufacturer
10.
Product Registration Holder
11.
Date of revision
12.
Serial Number
WHAT XELODA IS USED FOR
Xeloda is used in the treatment of
colon, rectal, gastric, or breast
cancers. Furthermore, Xeloda is used
to prevent new occurrence of colon
cancer after complete removal of the
tumour by surgery.
Xeloda may be used either alone or
in combination with other medicines.
HOW XELODA WORKS
Xeloda belongs to the group of
medicines called "cytostatic
medicines", which stop the growth of
cancer cells. Xeloda contains
capecitabine, which itself is not a
cytostatic medicine. Only after being
absorbed by the body is it changed
into an active anti-cancer medicine
(more in tumour tissue than in
normal tissue).
BEFORE YOU USE XELODA
-
_When you must not use it _
Do not take Xeloda if:
-
You are allergic to capecitabine or
any of the other ingredients of this
medicine (listed at the end of this
leaflet). You must inform your
doctor if you know that you have
an allergy or over-reaction to this
medicine,
-
if you previously have had severe
reactions to fluoropyrimidine
therapy (a group of anticancer
medicines such as fluorouracil),
-
if you are pregnant or breast-
feeding,
-
if you have severely low levels of
white cells or platelets in the blood
(leucopenia, neutropenia or
thrombocytopenia),
-
if you have severe liver or kidney
problems,
-
if you know that you do not have
any activity of the enzyme
dihydropyrimidine dehydrogenase
(DPD),
-
if you are being treated now or
have been treated in the last 4
weeks with brivudine as part of
herpes zoster (chickenpox or
shingles) therapy.
_Children and adolescents _
Xeloda is not indicated in children
and adolescents. Do not give Xeloda
to children and ado

Ciri produk

PACK INSERT FOR MALAYSIA
XELODA
®
CAPECITABINE
1.
DESCRIPTION
1.1
THERAPEUTIC/PHARMACOLOGIC CLASS OF DRUG
Cytostatic agent
ATC Code : L01BC06
1.2
TYPE OF DOSAGE FORM
Tablets 150 mg and 500 mg.
1.3
ROUTE OF ADMINISTRATION
Oral
1.4
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Active ingredient_
: capecitabine.
_150mg: _
Light peach, biconvex and oblong-shaped film-coated tablets containing
150 mg capecitabine. The tablets are engraved
"XELODA" on one side and "150" on the other side.
_500mg:_
Peach, biconvex, and oblong-shaped film-coated tablets containing 500
mg capecitabine. The tablets are engraved
“XELODA” on one side and “500” on the other side.
_ _
2
.
CLINICAL PARTICULARS
2.1
THERAPEUTIC INDICATION(S)
_Breast Cancer: _
Xeloda in combination with docetaxel is indicated for the treatment of
patients with locally advanced or metastatic breast
cancer after failure of cytotoxic chemotherapy. Previous therapy
should have included an anthracycline. Xeloda is also
indicated as monotherapy for the treatment of patients with locally
advanced or metastatic breast cancer after failure of a
taxane and an anthracycline-containing chemotherapy regimen or for
whom further anthracycline therapy is not indicated.
Xeloda is indicated in combination with lapatinib ditosylate for the
treatment of patients with advanced or metastatic breast
cancer whose tumors over express HER2 and who have received prior
therapy including an anthracycline, a taxane and
trastuzumab.
_Colon, Colorectal cancer: _
Xeloda is indicated for the treatment of patients with metastatic
colorectal carcinoma.
Xeloda is indicated as adjuvant treatment of patients following
surgery of Stage III (Duke’s Stage C) colon cancer.
_Oesophagogastric Cancer: _
Xeloda is indicated as first-line treatment of patients with advanced
oesophagogastric cancer in combination with a
platinum-based regimen.
2.2
DOSAGE AND ADMINISTRATION
_STANDARD DOSAGE _
Xeloda tablets should be swallowed whole with water within 30 minutes
after a meal.
Xeloda tablets should not be cr