Capercit

Држава: Нови Зеланд

Језик: Енглески

Извор: Medsafe (Medicines Safety Authority)

Активни састојак:

Capecitabine 500mg

Доступно од:

Dr Reddy's New Zealand Limited

INN (Међународно име):

Capecitabine 500 mg

Дозирање:

500 mg

Фармацеутски облик:

Film coated tablet

Састав:

Active: Capecitabine 500mg Excipient: Croscarmellose sodium Hypromellose Opadry Pink 03A540003 Lactose Magnesium stearate Microcrystalline cellulose

Тип рецептора:

Prescription

Произведен од:

Dr Reddy's Laboratories Limited

Терапеутске индикације:

Capercit tablets are indicated for the adjuvant treatment of patients with Dukes stage C and higher-risk stage B colon cancer, either as monotherapy or in combination with oxaloplatin

Резиме производа:

Package - Contents - Shelf Life: Blister pack, PVC/PE/PVDC blister with Alu film lid in printed carton - 120 tablets - 36 months from date of manufacture stored at or below 25°C

Датум одобрења:

2013-06-11

Информативни летак

1
CAPERCIT CMI V2
CAPERCIT
_FILM-COATED TABLETS_
_contains the active ingredient capecitabine_
_ _
CONSUMER MEDICINE INFORMATION
such as
chemotherapy
•
swelling of the face, lips,
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions
about
CAPERCIT 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
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
CAPERCIT contains the
active
ingredient capecitabine.
CAPERCIT belongs to a
group
of
medicines
called
anti-
neoplastic
agents.
Within
this
group, CAPERCIT
belongs to a
class
of
medicines
called
fluoropyrimidine
analogues.
CAPERCIT
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,
medicines.
The
medicine
contained
in
CAPERCIT
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
CAPERCIT
for
another purpose.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS
WHY
CAPERCIT
HAS BEEN
PRESCRIBED FOR YOU.
This medicine is available only
with a doctor's prescription.
CAPERCIT is not
addictive.
BEFORE YOU TAKE
THIS MEDICINE
_WHEN YOU MUST NOT TAKE _
_IT_
DO NOT TAKE CAPERCIT
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

Карактеристике производа

1
NEW ZEALAND DATASHEET
1 PRODUCT NAME
Capercit tablets
Capecitabine 150 mg and 500 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablets contains 150 mg or 500 mg of capecitabine.
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capercit film-coated tablets 150 mg: light peach colour film–coated
tablet of biconvex,
oblong shape with ‘150’ debossed on one side and ‘RDY’ on the
other side.
Capercit film-coated tablets 500 mg: peach colour film–coated tablet
of biconvex, oblong
shape with ‘500’ debossed on one side and ‘RDY’ on the other
side.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
BREAST CANCER
Capercit tablets are 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.
Capercit tablets in combination with docetaxel are indicated for the
treatment of patients
with locally advanced or metastatic breast cancer after failure of
prior anthracycline
containing chemotherapy.
COLON CANCER
Capercit tablets are 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
Capercit tablets are indicated for the first-line treatment of
patients with metastatic
colorectal cancer.
OESOPHAGOGASTRIC CANCER
Capercit tablets
are indicated for
the first-line treatment
of
patients with advanced
oesophagogastric cancer in combination with a platinum-based regimen.
2
4.2 DOSE AND METHOD OF ADMINISTRATION
STANDARD DOSAGE
Capercit tablets should be swallowed with water within 30 minutes
after the end of a meal.
_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 mg/m
2
total daily dose) for 2 weeks
followed by a 7 da