Capecitabine Accord

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

capecitabine

Διαθέσιμο από:

Accord Healthcare S.L.U.

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 Accord is indicated for the adjuvant treatment of patients following surgery of stage-III (Dukes’ stage-C) colon cancer.Capecitabine Accord is indicated for the treatment of metastatic colorectal cancer.Capecitabine Accord is indicated for first-line treatment of advanced gastric cancer in combination with a platinum-based regimen.Capecitabine Accord 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 Accord 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: 16

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2012-04-20

Φύλλο οδηγιών χρήσης

46
B. PACKAGE LEAFLET
47
PACKAGE LEAFLET: INFORMATION FOR THE USER
CAPECITABINE ACCORD 150 MG FILM-COATED TABLETS
CAPECITABINE ACCORD 300 MG FILM-COATED TABLETS
CAPECITABINE ACCORD 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 Accord is and what it is used for
2.
What you need to know before you take Capecitabine Accord
3.
How to take Capecitabine Accord
4.
Possible side effects
5.
How to store Capecitabine Accord
6.
Contents of the pack and other information
1.
WHAT CAPECITABINE ACCORD IS AND WHAT IT IS USED FOR
Capecitabine Accord belongs to the group of medicines called
"cytostatic medicines", which stop the
growth of cancer cells. Capecitabine Accord 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 Accord is used in the treatment of colon, rectal,
gastric, or breast cancers.
Furthermore, Capecitabine Accord is used to prevent new occurrence of
colon cancer after complete
removal of the tumour by surgery.
Capecitabine Accord may be used either alone or in combination with
other medicines.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CAPECITABINE ACCORD
DO NOT TAKE CAPECITABINE ACCORD
•
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-reactio

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Capecitabine Accord 150 mg film-coated tablets
Capecitabine Accord 300 mg film-coated tablets
Capecitabine Accord 500 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Capecitabine Accord 150 mg film-coated tablets
Each film-coated tablet contains 150 mg of capecitabine.
Capecitabine Accord 300 mg film-coated tablets
Each film-coated tablet contains 300 mg of capecitabine.
Capecitabine Accord 500 mg film-coated tablets
Each film-coated tablet contains 500 mg of capecitabine.
Excipient with known effect
_ _
_Capecitabine Accord 150 mg film-coated tablets _
Each film-coated tablet contains 7 mg anhydrous lactose.
_Capecitabine Accord 300 mg film-coated tablets _
Each film-coated tablet contains 15 mg anhydrous lactose
_Capecitabine Accord 500 mg film-coated tablets _
Each film-coated tablet contains 25 mg anhydrous lactose
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Capecitabine Accord 150 mg film-coated tablets
The film-coated tablets are light peach colored, oblong shaped,
biconvex, 11.4 mm in length and
5.3 mm in width, debossed with ‘150’ on one side and plain on
other side.
Capecitabine Accord 300 mg film-coated tablets
The film-coated tablets are white to off white, oblong shaped,
biconvex, 14.6 mm in length and
6.7 mm in width, debossed with ‘300’ on one side and plain on
other side.
Capecitabine Accord 500 mg film-coated tablets
The film-coated tablets are peach colored, oblong shaped, biconvex,
15.9 mm in length and 8.4 mm in
width, debossed with ‘500’ on one side and plain on other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Capecitabine Accord is indicated for the treatment of:
3
-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 r