Capecitabine Viatris

País: Nova Zelândia

Língua: inglês

Origem: Medsafe (Medicines Safety Authority)

Ingredientes ativos:

Capecitabine 500mg;  ;  

Disponível em:

Viatris Limited

Dosagem:

500 mg

Forma farmacêutica:

Film coated tablet

Composição:

Active: Capecitabine 500mg     Excipient: Croscarmellose sodium Hypromellose   Iron oxide red Iron oxide yellow Lactose Magnesium stearate Microcrystalline cellulose Purified talc Purified water Titanium dioxide

Tipo de prescrição:

Prescription

Indicações terapêuticas:

Capecitabine Viatris tablets in combination with docetaxel is indicated for the treatment of patients with locally-advanced or metastatic breast cancer after failure of prior anthracycline-containing chemotherapy. Capecitabine Viatris tablets as monotherapy is indicated for the treatment of patients with locally-advanced or metastatic breast cancer after failure of both a taxane-containing and anthracycline-containing chemotherapy or in whom taxane-containing and anthracycline-containing therapy are not indicated.

Resumo do produto:

Package - Contents - Shelf Life: Blister pack, PVC/PVdC-Al or Al-Al - 120 tablets - 36 months from date of manufacture stored at or below 25°C

Data de autorização:

2017-09-04

Folheto informativo - Bula

Page 1 of 5
NEW ZEALAND CONSUMER MEDICINE INFORMATION
CAPECITABINE VIATRIS
_CAPECITABINE FILM COATED TABLETS 150 MG AND 500 MG_
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start taking
CAPECITABINE VIATRIS.
This leaflet answers some common
questions about CAPECITABINE
VIATRIS.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking
CAPECITABINE VIATRIS against
the benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE. You may need to read it
again.
WHAT
CAPECITABINE
VIATRIS IS USED FOR
CAPECITABINE VIATRIS is used to
treat cancer of the bowel and
rectum (colorectal), breast and
stomach and food pipe
(oesophagus). It may be prescribed
alone or in combination with other
medicines used to treat cancer,
such as chemotherapy medicines.
This medicine belongs to a group of
medicines called anti-neoplastic
agents. Within this group,
CAPECITABINE VIATRIS belongs
to a class of medicines called
fluoropyrimidine analogues.
CAPECITABINE VIATRIS contains
the active ingredient Capecitabine.
Capecitabine is converted by the
liver and cancer cells to another
medicine called 5-fluorouracil (also
called 5-FU). It is 5-FU that acts to
kill or stop the growth of cancer
cells.
Your doctor may have prescribed
this medicine for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED FOR
YOU.
This medicine is available only with
a doctor’s prescription.
BEFORE YOU TAKE
CAPECITABINE
VIATRIS
_WHEN YOU MUST NOT TAKE _
_IT_
DO NOT TAKE CAPECITABINE
VIATRIS IF YOU HAVE AN ALLERGY TO:

any medicine containing
Capecitabine

any of the ingredients listed
at the end of this leaflet

5-fluorouracil (also called 5-
FU), a medicine used to
treat cancer

Other fluoropyrimidine
medicines
Some of the symptoms of a

Características técnicas

Page 1 of 29
NEW ZEALAND DATA SHEET
CAPECITABINE VIATRIS
1. PRODUCT NAME
CAPECITABINE VIATRIS, 150 mg and 500 mg film-coated tablets.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each CAPECITABINE VIATRIS 150 mg film-coated tablet contains 150 mg of
capecitabine.
Each CAPECITABINE VIATRIS 500 mg film-coated tablet contains 500 mg of
capecitabine.
Excipient with known effect: Lactose
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
CAPECITABINE VIATRIS 150 mg film-coated tablets are light peach
coloured, oblong shaped,
biconvex, film-coated tablets, debossed with “150” on one side and
plain on the other side.
CAPECITABINE VIATRIS 500 mg film-coated tablets are peach coloured,
oblong shaped, biconvex,
film-coated tablets, debossed with “500” on one side and plain on
the other side.
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS_
BREAST CANCER
CAPECITABINE VIATRIS tablets in combination with docetaxel is
indicated for the treatment of
patients with locally-advanced or metastatic breast cancer after
failure of prior anthracycline-
containing chemotherapy.
CAPECITABINE VIATRIS tablets as monotherapy is indicated for the
treatment of patients with
locally-advanced
or
metastatic
breast
cancer
after
failure
of
both
a
taxane-containing
and
anthracycline-containing chemotherapy or in whom taxane-containing and
anthracycline-containing
therapy are not indicated.
COLON CANCER
CAPECITABINE VIATRIS tablets as monotherapy or in combination with
oxaliplatin is indicated for
the adjuvant treatment of patients with Dukes’ stage C and high-risk
stage B colon cancer, either as
monotherapy or in combination with oxaliplatin.
COLORECTAL CANCER
CAPECITABINE VIATRIS tablets as monotherapy is indicated for the
first-line treatment of patients
with metastatic colorectal cancer.
Page 2 of 29
OESOPHAGOGASTRIC CANCER
CAPECITABINE VIATRIS tablets in combination with platinum-based
chemotherapy is indicated for
the first-line treatment of patients with advanced oesophagogastric
cancer.
_4.2_
_DOSE AND