CAPECITABINE AN capecitabine 150 mg film-coated tablet blister pack

Χώρα: Αυστραλία

Γλώσσα: Αγγλικά

Πηγή: Department of Health (Therapeutic Goods Administration)

Δραστική ουσία:

capecitabine

Διαθέσιμο από:

Juno Pharmaceuticals Pty Ltd

INN (Διεθνής Όνομα):

Capecitabine

Καθεστώς αδειοδότησης:

Registered

Φύλλο οδηγιών χρήσης

Capecitabine AN CMI v3.0
1
CAPECITABINE AN
_ _
_Capecitabine _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Capecitabine AN.
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
Medicine
Name
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 AN
IS USED FOR
Capecitabine AN contains the
active ingredient capecitabine.
Capecitabine AN belongs to a
group of medicines called anti-
neoplastic agents. Within this
group, Capecitabine AN belongs to
a class of medicines called
fluoropyrimidine analogues.
Capecitabine AN 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
The medicine contained in
Capecitabine AN tablets,
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 Capecitabine AN
for another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS WHY CAPECITABINE AN
HAS BEEN PRESCRIBED FOR YOU.
This medicine is available only
with a doctor's prescription.
_Capecitabine AN is not addictive._
BEFORE
YOU
TAKE
CAPECITABINE AN
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE CAPECITABINE AN IF:
1. YOU HAVE HAD AN ALLERGY TO
• CAPECITABINE OR 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 an
allergic reaction may include:
• shortness of breath
• wheezing or difficulty in
breat

Αρχείο Π.Χ.Π.

Capecitabine AN (Capecitabine Tablets 150 mg and 500 mg)
-Capecitabine AN PI v3.0
Page 1 of 33
PRODUCT INFORMATION
CAPECITABINE AN
(CAPECITABINE FILM-COATED TABLETS 150 MG AND 500 MG)
NAME OF THE MEDICINE
Capecitabine
(CAS Registry Number: 154361-50-9)
The chemical name for capecitabine is
5’-deoxy-5-fluoro-N-[(pentyloxy)carbonyl]- cytidine
with the molecular formula C
15
H
22
FN
3
O
6
and a molecular weight of 359.35.
DESCRIPTION
Capecitabine is an oral, antineoplastic agent belonging to the
fluoropyrimidine carbamate
class.
It was rationally
designed
as an orally
administered
precursor
of 5’-deoxy-5-
fluorouridine (5’-DFUR), which is selectively activated to the
cytotoxic moiety, fluorouracil,
in tumours. Capecitabine
is a white to off-white crystalline powder with an aqueous
solubility of 26 mg/mL at 20°C.
Capecitabine AN is supplied as oblong shaped, biconvex film-coated
tablets for oral
administration. Each light peach coloured tablet contains 150 mg
capecitabine and each
peach coloured tablet contains 500 mg capecitabine. The inactive
ingredients in
Capecitabine AN are lactose anhydrous, cellulose microcrystalline,
croscarmellose sodium,
hypromellose, and magnesium stearate. The peach or light peach film
coating contains
hypromellose, purified talc, titanium dioxide and iron oxide yellow
and iron oxide red.
PHARMACOLOGY
Capecitabine itself is non-cytotoxic; however, it is selectively
activated to the cytotoxic
moiety, fluorouracil (5-FU), by thymidine phosphorylase in tumours.
PHARMACODYNAMICS
BIOACTIVATION
Capecitabine is a fluoropyrimidine carbamate derivative that was
designed as an orally
administered,
tumour-activated
and
tumour-selective
cytotoxic
agent.
Capecitabine
is
noncytotoxic
_in vitro_
.
Capecitabine is absorbed unchanged from the gastrointestinal tract,
metabolised primarily
in the liver by the 60 kDa carboxylesterase to
5’-deoxy-5-fluorocytidine (5’-DFCR),
Capecitabine AN (Capecitabine Tablets 150 mg and 500 mg)
-Capecitabine AN PI v3.0
Page 2 of 33
which is then converted to 5’