CAPECITABINE APOTEX capecitabine 500 mg tablet blister pack

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv bestanddel:

capecitabine

Tilgængelig fra:

Apotex Pty Ltd

INN (International Name):

Capecitabine

Autorisation status:

Registered

Indlægsseddel

CAPECITABINE APOTEX
TABLETS
_Contains the active ingredient capecitabine_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about this medicine. 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 this medicine
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 THIS MEDICINE IS
USED FOR
The name of your medicine is
Capecitabine APOTEX. It contains
the active ingredient capecitabine.
It is used to treat cancer of the:
•
bowel and rectum (colorectal)
•
breast and stomach and food pipe
(oesophagus).
Capecitabine belongs to a group of
medicines called anti-neoplastic
agents. Within this group,
capecitabine belongs to a class of
medicines called fluoropyrimidine
analogues.
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.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed this
medicine for another reason.
There is no evidence that this
medicine is addictive.
This medicine is available only with
a doctor's prescription.
DO NOT GIVE CAPECITABINE TO
CHILDREN.
Safety and effectiveness of this
medicine in persons under 18 years
of age have not been established.
BEFORE YOU TAKE THIS
MEDICINE
_WHEN YOU MUST NOT USE IT_
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
capecitabine
•
5-fluorouracil (also called 5-FU)
•
other fluoropyrimidine medicines
•
any of the ingredients listed at the
end of this leaflet
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•

Produktets egenskaber

1
AUSTRALIAN PRODUCT INFORMATION
CAPECITABINE APOTEX (CAPECITABINE) TABLETS
1
NAME OF THE MEDICINE
Capecitabine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains either 150 mg or 500 mg capecitabine.
EXCIPIENTS WITH KNOWN EFFECT
Lactose
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
CAPECITABINE 150 MG TABLETS
Light peach, oval, biconvex, film-coated tablet, engraved “APO” on
one side, “C150” on the
other side.
CAPECITABINE 500 MG TABLETS:
Peach, oval, biconvex, film-coated tablet, engraved “APO” on one
side, “C500” on the other
side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
COLON CANCER
Capecitabine 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 is indicated for the treatment of patients with advanced
or metastatic colorectal
cancer.
OESOPHAGOGASTRIC CANCER
Capecitabine is indicated for the first-line treatment of patients
with advanced
oesophagogastric cancer in combination with a platinum-based regimen.
BREAST CANCER
Capecitabine is indicated for the treatment of patients with locally
advanced or metastatic
breast cancer after failure of taxanes and an anthracycline containing
chemotherapy regimen
unless therapy with these and other standard agents are clinically
contraindicated.
Capecitabine 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.
2
4.2
DOSE AND METHOD OF ADMINISTRATION
Capecitabine APOTEX tablets are intended for oral administration.
Capecitabine tablets should be swallowed with water within 30 minutes
after the end of a meal.
DOSAGE
STANDARD DOSAGE
_Monotherapy - Colon, colorectal, breast cancer _
The recommended monotherapy starting dose of capecitabine is 1250 mg/m
2
administered
twice daily (morning and evening; equivalent to 2500