CAPIIBINE 500 (Capecitabine Film-Coated Tablets 500mg USP)

País: Malasia

Idioma: inglés

Fuente: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Ingredientes activos:

CAPECITABINE

Disponible desde:

Dr. Reddy`s Laboratories Malaysia Sdn. Bhd.

Designación común internacional (DCI):

CAPECITABINE

Unidades en paquete:

120 Tablets

Fabricado por:

DR. REDDY'S LABORATORIES LIMITED

Información para el usuario

1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
CAPIIBINE 150
CAPIIBINE 500
_Capecitabine Film-Coated Tablets USP (150mg, 500mg)_
WHAT IS IN THIS LEAFLET
1.
What Capiibine is used for
2.
How Capiibine works
3.
Before you use Capiibine
4.
How to use Capiibine
5.
While you are using it
6.
Side effects
7.
Storage and disposal of Capiibine
8.
Product description
9.
Manufacturer
10.
Product Registration Holder
11.
Date of revision
12.
Serial Number
WHAT CAPIIBINE IS USED FOR
Capiibine is used in the treatment of
colon, rectal, gastric, or breast cancers.
Furthermore, Capiibine is used to
prevent new occurrence of colon cancer
after complete removal of the tumour by
surgery.
Capiibine may be used either alone or in
combination with other medicines.
HOW CAPIIBINE WORKS
Capiibine belongs to the group of
medicines called "cytostatic medicines",
which stop the growth of cancer cells.
Capiibine contains capecitabine, which
itself is not a cytostatic medicine. Only
after being absorbed by the body is it
changed into an active anti-cancer
medicine (more in tumour tissue than in
normal tissue).
BEFORE YOU USE CAPIIBINE
-
_When you must not use it _
Do not take Capiibine if:
-
You are allergic to capecitabine or any
of the other ingredients of this medicine
(listed at the end of this leaflet). You
must inform your doctor if you know that
you have an allergy or over-reaction to
this medicine,
-
if you previously have had severe
reactions to fluoropyrimidine therapy (a
group of anticancer medicines such as
fluorouracil),
-
if you are pregnant or breast- feeding,
-
if you have severely low levels of white
cells or platelets in the blood (leucopenia,
neutropenia or thrombocytopenia),
-
if you have severe liver or kidney
problems,
-
if you know that you do not have any
activity of the enzyme
dihydropyrimidine dehydrogenase
(DPD),
-
if you are being treated now or have
been treated in the last 4 weeks with
brivudine as part of herpes zoster
(chickenpox or shingles) therapy.
_Children and adolescents _
Capiibine is not indicated

Ficha técnica

1
_For the use of an oncologist or a hospital or a laboratory only _
_ _
PRESCRIBING INFORMATION
CAPIIBINE
CAPECITABINE FILM-COATED TABLETS USP 150 MG AND
CAPECITABINE FILM-COATED TABLETS USP 500 MG
CAUTION: CYTOTOXIC AGENT
COMPOSITION
CAPIIBINE 150
Each film-coated tablet contains:
Capecitabine USP 150 mg
Colours: Titanium Dioxide, Red oxide of Iron and Yellow oxide of Iron
CAPIIBINE 500
Each film-coated tablet contains:
Capecitabine USP 500 mg
Colours: Titanium Dioxide, Red oxide of Iron and Yellow oxide of Iron
PRODUCT DESCRIPTION:
_Capecitabine Film-Coated tablets USP 150 mg_
:
Light peach colored, biconvex, oblong film coated tablets with
“150” debossing on one side and ‘RDY’
on other side.
_Capecitabine Film-Coated tablets USP 500 mg_
:
Peach colored, biconvex, oblong tablets with “500” debossing on
one side and ‘RDY’ on other side.
CLINICAL INFORMATION
THERAPEUTIC INDICATIONS:
_Breast Cancer: _
CAPIIBINE in combination with docetaxel is indicated for the treatment
of patients with locally
advanced or metastatic breast cancer after failure of cytotoxic
chemotherapy. Previous therapy should
have included an anthracycline. CAPIIBINE is also indicated as
monotherapy for the treatment of
patients
with
locally
advanced
or
metastatic
breast
cancer
after
failure
of
a
taxane
and
an
anthracycline-containing chemotherapy regimen or for whom further
anthracycline therapy is not
indicated.
CAPIIBINE is indicated in combination with lapatinib ditosylate for
the treatment of patients with
advanced or metastatic breast cancer whose tumors over express HER2
and who have received prior
therapy including an anthracycline, a taxane and trastuzumab.
Colon,
_Colorectal cancer: _
2
CAPIIBINE is indicated for the treatment of patients with metastatic
colorectal carcinoma.
CAPIIBINE is indicated as adjuvant treatment of patients following
surgery of Stage III (Duke’s Stage
C) colon cancer.
_Oesophagogastric Cancer: _
CAPIIBINE is indicated as first-line treatment of patients with
advanced oesophagogastric cancer