Capecitabine Teva

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

capecitabine

Διαθέσιμο από:

Teva Pharma B.V.

Φαρμακολογική κατηγορία (ATC):

L01BC06

INN (Διεθνής Όνομα):

capecitabine

Θεραπευτική ομάδα:

Antineoplastic agents

Θεραπευτική περιοχή:

Colonic Neoplasms; Breast Neoplasms; Colorectal Neoplasms; Stomach Neoplasms

Θεραπευτικές ενδείξεις:

Capecitabine Teva is indicated for the adjuvant treatment of patients following surgery of stage III (Dukes’ stage C) colon cancer.Capecitabine Teva is indicated for the treatment of metastatic colorectal cancer.Capecitabine Teva is indicated for first‑line treatment of advanced gastric cancer in combination with a platinum‑based regimen.Capecitabine Teva 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. Capecitabine Teva 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: 15

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2012-04-20

Φύλλο οδηγιών χρήσης

40
B. PACKAGE LEAFLET
41
PACKAGE LEAFLET: INFORMATION FOR THE USER
_ _
CAPECITABINE TEVA 150 MG FILM-COATED TABLETS
CAPECITABINE TEVA 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 Capecitabine Teva is and what it is used for
2.
What you need to know before you take Capecitabine Teva
3.
How to take Capecitabine Teva
4.
Possible side effects
5.
How to store Capecitabine Teva
6.
Contents of the pack and other information
1.
WHAT CAPECITABINE TEVA IS AND WHAT IT IS USED FOR
Capecitabine Teva belongs to the group of medicines called "cytostatic
medicines", which stop the
growth of cancer cells. Capecitabine Teva 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).
Capecitabine Teva is used in the treatment of colon, rectal, gastric,
or breast cancers. Furthermore,
Capecitabine Teva is used to prevent new occurrence of colon cancer
after complete removal of the
tumour by surgery.
Capecitabine Teva may be used either alone or in combination with
other medicines.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CAPECITABINE TEVA
_ _
DO NOT TAKE CAPECITABINE TEVA_ _
-
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 fluor

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1. NAME OF THE MEDICINAL PRODUCT
Capecitabine Teva 150 mg film-coated tablets
Capecitabine Teva 500 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Capecitabine Teva 150 mg film-coated tablets
Each film-coated tablet contains 150 mg capecitabine.
Capecitabine Teva 500 mg film-coated tablets
Each film-coated tablet contains 500 mg capecitabine.
Excipient with known effect
_Capecitabine Teva 150 mg film-coated tablets _
Each film-coated tablet contains 15.6 mg lactose.
_Capecitabine Teva 500 mg film-coated tablets _
Each film-coated tablet contains 52.0 mg lactose.
For the full list of excipients, see section 6.1.
_ _
3.
PHARMACEUTICAL FORM
Film-coated tablet
Capecitabine Teva 150 mg film-coated tablets
The film-coated tablets are oval biconvex light peach, 11.5 mm x 5.4
mm with inscription “C” on one
side and “150”on the other side.
Capecitabine Teva 500 mg film-coated tablets
The film-coated tablets are oval biconvex light peach, 16.0 mm x 8.5
mm with inscription “C” on one
side and “500”on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Capecitabine Teva 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.
-
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.
3
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Capecitabine Teva should only be prescribed by