Capecitabine Sandoz 500 mg Film-coated tablets

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

Capecitabine

Tillgänglig från:

Rowex Ltd

ATC-kod:

L01BC; L01BC06

INN (International namn):

Capecitabine

Dos:

500 milligram(s)

Läkemedelsform:

Film-coated tablet

Receptbelagda typ:

Product subject to prescription which may not be renewed (A)

Terapiområde:

Pyrimidine analogues; capecitabine

Bemyndigande status:

Marketed

Tillstånd datum:

2013-05-17

Bipacksedel

PACKAGE LEAFLET: INFORMATION FOR THE USER
CAPECITABINE SANDOZ 150 MG FILM-COATED TABLETS
CAPECITABINE SANDOZ 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 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 previously have had severe reactions to

Produktens egenskaper

Health Products Regulatory Authority
03 October 2019
CRN008HGY
Page 1 of 23
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Capecitabine Sandoz 500 mg Film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 500 mg capecitabine
Excipient(s) with known effect:
Each film-coated tablet contains 43.7 mg lactose (as lactose
monohydrate).
3 PHARMACEUTICAL FORM
Film-coated tablet
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 POSOLOGY AND METHOD OF ADMINISTRATION
Capecitabine Sandoz should only be prescribed by a qualified physician
experienced in the utilisation of anti-neoplastic
medicinal products. Careful monitoring during the first cycle of
treatment is recommended for all patients.
Treatment should be discontinued if progressive disease or intolerable
toxicity is observed. Standard and reduced dose
calculations according to body surface area for starting doses of
Capecitabine Sandoz of 1250 mg/m
2
and 1000 mg/m
2
are
provided in tab