CAPEX capecitabine 150 mg film-coated tablet blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
24-08-2020
Summary of Product characteristics
(SPC)
24-08-2020
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
capecitabine
Available from:
Medis Pharma Pty Ltd
INN (International Name):
Capecitabine
Authorization status:
Registered
Patient Information leaflet
CAPEX
CONSUMER MEDICINE INFORMATION
Version: 1.0
-2014-
Page: 1 of 5
CAPEX
(CAPECITABINE FILM-COATED TABLETS 150 MG AND 500 MG)
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions
about
Capex
tablets.
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
Capex tablets 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 CAPEX IS USED
FOR
Capex contains the active
ingredient capecitabine.
Capex belongs to a group of
medicines called anti-neoplastic
agents. Within this group, Capex
belongs to a class of medicines
called fluoropyrimidine
analogues.
Capex 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
Capex 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 Capex for
another purpose.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS WHY CAPEX HAS
BEEN PRESCRIBED FOR YOU.
This medicine is available only
with a doctor's prescription.
_Capex is not addictive._
BEFORE YOU TAKE
CAPEX
WHEN YOU MUST NOT TAKE IT
DO NOT TAKE CAPEX 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
breathing
•
swelling of the face, lips,
tongue or oth
Read the complete document
Summary of Product characteristics
Capex (Capecitabine Tablets 150 mg and 500 mg)
Version 1.0
-2014-
Page 1 of 33
PRODUCT INFORMATION
CAPEX
(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.
Capex 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 Capex
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),
Capex (Capecitabine Tablets 150 mg and 500 mg)
Version 1.0
-2014-
Page 2 of 33
which is then converted to 5’-DFUR by cytidine deaminase,
principally located in the
liver
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