Capecitabine Sandoz 150 mg, filmomhulde tabletten

Pajjiż: Olanda

Lingwa: Olandiż

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

Ingredjent attiv:

CAPECITABINE 150 mg/stuk

Disponibbli minn:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

Kodiċi ATC:

L01BC06

INN (Isem Internazzjonali):

CAPECITABINE 150 mg/stuk

Għamla farmaċewtika:

Filmomhulde tablet

Kompożizzjoni:

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

Rotta amministrattiva:

Oraal gebruik

Żona terapewtika:

Capecitabine

Sommarju tal-prodott:

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);

Data ta 'l-awtorizzazzjoni:

1900-01-01

Fuljett ta 'informazzjoni

Sandoz B.V.
Page 1/8
Capecitabine Sandoz 150/500 mg
RVG 110880/1
1313-v12
1.3.1.3 Bijsluiter
Februari 2021
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 [Nationally completed name] is and what it is used for
2.
What you need to know before you take [Nationally completed name]
3.
How to take [Nationally completed name]
4.
Possible side effects
5.
How to store [Nationally completed name]
6.
Contents of the pack and other information
1.
WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR
[Nationally completed name] belongs to the group of medicines called
"cytostatic medicines", which
stop the growth of cancer cells. [Nationally completed name] 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).
[Nationally completed name] is used in the treatment of colon, rectal,
gastric, or breast
cancers. Furthermore, [Nationally completed name] is used to prevent
new occurrence of colon
cancer after complete removal of the tumour by surgery.
[Nationally completed name] may be used either alone or in combination
with other medicines.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE [NATIONALLY COMPLETED NAME]
DO NOT TAKE [NATIONALLY COMPLETED NAME]:
•
if you are allergic to capecitabine or any of

Karatteristiċi tal-prodott

Sandoz B.V.
Page 1/29
Capecitabine Sandoz 150/500 mg
RVG 110880/1
v11
1.3.1.1 Samenvatting van de productkenmerken
Februari 2021
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
[Nationally completed name] 150 mg film-coated tablets:
Each film-coated tablet contains 150 mg of capecitabine.
Excipient(s) with known effect:
Each film-coated tablet contains 13.1 mg of lactose (as lactose
monohydrate).
[Nationally completed name] 500 mg film-coated tablets:
Each film-coated tablet contains 500 mg of capecitabine.
Excipient(s) with known effect:
Each film-coated tablet contains 43.7 mg of lactose (as lactose
monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
[Nationally completed name] 150 mg film-coated tablets:
Light pink film-coated tablet of modified oval shape (5.5 x 11.0 mm)
with the marking “150” on one
side.
[Nationally completed name 500] mg film-coated tablets:
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
[Nationally completed name] is indicated for the adjuvant treatment of
patients following surgery of
stage III (Dukes’ stage C) colon cancer (see section 5.1).
[Nationally completed name] is indicated for the treatment of
metastatic colorectal cancer (see section
5.1).
[Nationally completed name] is indicated for first-line treatment of
advanced gastric cancer in
combination with a platinum-based regimen (see section 5.1).
[Nationally completed name] 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.
[Nationally completed name]
is also indicated as monoth