Capecitabine Sandoz 500mg film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CAPECITABINE

Available from:

Sandoz Pharmaceuticals d.d. Verovškova Ulica 57, SI-1000 Ljubljana, Slovenia

ATC code:

L01BC06

INN (International Name):

CAPECITABINE 500 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

CAPECITABINE 500 mg

Prescription type:

POM

Therapeutic area:

ANTINEOPLASTIC AGENTS

Authorization status:

Withdrawn

Authorization date:

2013-03-28

Patient Information leaflet

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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

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Capecitabine Sandoz 150 mg film-coated tablets
Capecitabine Sandoz 500 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Capecitabine Sandoz 150 mg film-coated tablets:
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 film-coated tablets:
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 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.
Capecitabine Sandoz 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
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
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failure of taxanes and an anthracycline-containing chemotherapy
regimen or for whom further
anthracycline therapy is not indicated.
4.2
POSOLOGY AND METHOD OF ADMINISTRATI