Capecitabine Sandoz 150 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

CAPECITABINE;

Beschikbaar vanaf:

Sandoz B.V.

ATC-code:

L01BC06

INN (Algemene Internationale Benaming):

CAPECITABINE;

farmaceutische vorm:

Filmomhulde tablet

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Capecitabine

Product samenvatting:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSCARMELLOSE NATRIUM (E 468); HYPROMELLOSE (E 464); IJZEROXIDE ROOD (E 172); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); TALK (E 553 B); TITAANDIOXIDE (E 171);

Bijsluiter

1.3.1.3 PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
CAPECITABINE SANDOZ 150 MG, FILMOMHULDE TABLETTEN
CAPECITABINE SANDOZ 500 MG, FILMOMHULDE TABLETTEN
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 or
nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Capecitabine Sandoz is and what it is used for
2.
What you need to know before you take Capecitabine Sandoz
3.
How to take Capecitabine Sandoz
4.
Possible side effects
5.
How to store Capecitabine Sandoz
6.
Contents of the pack and other information
1.
WHAT CAPECITABINE SANDOZ IS AND WHAT IT IS USED FOR
Capecitabine Sandoz belongs to the group of medicines called
"cytostatic medicines", which stop the
growth of cancer cells. Capecitabine Sandoz 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 Sandoz is used in the treatment of colon, rectal,
gastric, or breast cancers.
Furthermore, Capecitabine Sandoz is used to prevent new occurrence of
colon cancer after
complete removal of the tumour by surgery.
Capecitabine Sandoz may be used either alone or in combination with
other medicines.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CAPECITABINE SANDOZ
DO NOT TAKE CAPECITABINE SANDOZ:

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 previousl

Productkenmerken

1.3.1.1 SUMMARY OF PRODUCT CHARACTERISTICS
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Capecitabine Sandoz 150 mg, filmomhulde tabletten
Capecitabine Sandoz 500 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Capecitabine Sandoz 150 mg, filmomhulde tabletten:
Each film-coated tablet contains 150 mg capecitabine
Excipient(s) with known effect:
Each film-coated tablet contains 13.8 mg lactose monohydrate.
Capecitabine Sandoz 500 mg, filmomhulde tabletten:
Each film-coated tablet contains 500 mg capecitabine.
Excipient(s) with known effect:
Each film-coated tablet contains 46.0 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Capecitabine Sandoz 150 mg, filmomhulde tabletten:
Light pink film-coated tablet of modified oval shape (5.5 x 11.0 mm)
with the marking “150” on one
side.
Capecitabine Sandoz 500 mg, filmomhulde tabletten:
Pink film-coated tablet of modified oval shape (8.4 x 16.0 mm) with
the marking “500” on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Capecitabine Sandoz is indicated for the adjuvant treatment of
patients following surgery of stage III
(Dukes’ stage C) colon cancer (see section 5.1).
Capecitabine Sandoz is indicated for the treatment of metastatic
colorectal cancer (see section 5.1).
Capecitabine Sandoz is indicated for first-line treatment of advanced
gastric cancer in combination
with a platinum-based regimen (see section 5.1).
Capecitabine Sandoz in combination with docetaxel (see section 5.1) 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
Sandoz 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.
4.2