Xeloda

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

capecitabine

Διαθέσιμο από:

CHEPLAPHARM Arzneimittel GmbH

Φαρμακολογική κατηγορία (ATC):

L01BC06

INN (Διεθνής Όνομα):

capecitabine

Θεραπευτική ομάδα:

Antineoplastic agents

Θεραπευτική περιοχή:

Colonic Neoplasms; Breast Neoplasms; Colorectal Neoplasms; Stomach Neoplasms

Θεραπευτικές ενδείξεις:

Xeloda is indicated for the adjuvant treatment of patients following surgery of stage III (Dukes' stage C) colon cancer.Xeloda is indicated for the treatment of metastatic colorectal cancer.Xeloda is indicated for first-line treatment of advanced gastric cancer in combination with a platinum-based regimen.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 taxanes and an anthracycline-containing chemotherapy regimen or for whom further anthracycline therapy is not indicated.

Περίληψη προϊόντος:

Revision: 30

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2001-02-02

Φύλλο οδηγιών χρήσης

40
B. PACKAGE LEAFLET
41
PACKAGE LEAFLET: INFORMATION FOR THE USER
XELODA 150 MG FILM-COATED TABLETS
XELODA 500 MG FILM-COATED TABLETS
capecitabine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet (see section 4).
WHAT IS IN THIS LEAFLET
1.
What Xeloda is and what it is used for
2.
What you need to know before you take Xeloda
3.
How to take Xeloda
4.
Possible side effects
5.
How to store Xeloda
6.
Contents of the pack and other information
1.
WHAT XELODA IS AND WHAT IT IS USED FOR
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).
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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE XELODA
DO NOT TAKE XELODA:

if you are allergic to capecitabine or any of the other ingredients of
this medicine (listed in
section 6). 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 lev

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Xeloda 150 mg film-coated tablets.
Xeloda 500 mg film-coated tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Xeloda 150 mg film-coated tablets
Each film-coated tablet contains 150 mg capecitabine.
Xeloda 500 mg film-coated tablets
Each film-coated tablet contains 500 mg capecitabine
Excipient(s) with known effect
Xeloda 150 mg film-coated tablets
Each 150 mg film-coated tablet contains 15.6 mg anhydrous lactose.
Xeloda 500 mg film-coated tablets
Each 500 mg film-coated tablet contains 52 mg anhydrous lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Xeloda 150 mg film-coated tablets
The film-coated tablets are light peach tablets of biconvex, oblong
shape with the marking
‘150’ on the one side and ‘Xeloda’ on the other side
Xeloda 500 mg film-coated tablets
The film-coated tablets are peach tablets of biconvex, oblong shape
with the marking ‘500’ on the one
side and ‘Xeloda’ on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Xeloda is indicated for the treatment of:
-
for the adjuvant treatment of patients following surgery of stage III
(Dukes’ stage C) colon cancer
(see section 5.1).
-
metastatic colorectal cancer (see section 5.1).
-
first-line treatment of advanced gastric cancer in combination with a
platinum-based regimen
(see section 5.1).
-
in combination with docetaxel (see section 5.1) for the treatment of
patients with locally advanced
or metastatic breast cancer after failure of cytotoxic chemotherapy.
Previous therapy should have
included an anthracycline.
3
-
as monotherapy for the treatment of patients with locally advanced or
metastatic breast cancer
after failure of taxanes and an anthracycline-containing chemotherapy
regimen or for whom
further anthracycline therapy is not indicated.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Xeloda should only be prescribed by a qualified physician experienced
in the utilisation of anti-
neop