CAPTAB Capecitabine 500 mg Film Coated Tablets

Krajina: Malajzia

Jazyk: angličtina

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

Aktívna zložka:

CAPECITABINE

Dostupné z:

UNIMED SDN BHD

INN (Medzinárodný Name):

CAPECITABINE

Počet v balení:

30 Tablets; 120 Tablets

Výrobca:

Shilpa Medicare Limited

Príbalový leták

CAPTAB
Capecitabine 150mg Film-Coated Tablets/ Capecitabine 500mg Film-Coated
Tablets
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What CAPTAB is used for
2.
How CAPTAB works
3.
Before you use CAPTAB
4.
How to use CAPTAB
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of CAPTAB
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT CAPTAB
IS USED FOR
Captab is used in the treatment of colon,
rectal, gastric, or breast cancers.
Furthermore, Captab is used to prevent
new occurrence of colon cancer after
complete removal of the tumour by
surgery.
Captab may be used either alone or in
combination with other medicines.
HOW CAPTAB WORKS
Captab belongs to the group of
medicines called “cytostatic medicines",
which stop the growth of cancer cells.
Captab 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 CAPTAB
-
_When you must not use it_
Do not take Captab if you:
•
If you previously have had severe
reactions to fluoropyrimidine
therapy (a group of anticancer
medicines such as fluorouracil)
•
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 know that you do not have
any activity of the enzyme
dihydropyrimidine dehydrogenase
(DPD)
•
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 liver or kidney disease
•
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.
_Chi

Súhrn charakteristických

A.
PRODUCT NAME
CAPTAB Capecitabine 150 mg Film Coated Tablets
CAPTAB Capecitabine 500 mg Film Coated Tablets
B.
NAME AND STRENGTH OF ACTIVE SUBSTANCE(S)
Capecitabine & 150 mg
Capecitabine & 500 mg
C.
PRODUCT DESCRIPTION
CAPTAB Capecitabine 150 mg Film Coated Tablets is light pink colored,
capsule shaped, biconvex film coated tablet
debossed with CAP one side and 150 on other side.
Each film coated tablet contains: Capecitabine Ph.Eur......150 mg
CAPTAB Capecitabine 500 mg Film Coated Tablets is Dark pink colored,
capsule shaped, biconvex film coated tablet
debossed with CAP one side and 500 on other side.
Each film coated tablet contains: Capecitabine Ph.Eur......500 mg
D.
PHARMACODYNAMICS/PHARMACOKINETICS
D.1 PHARMACODYNAMIC PROPERTIES
Pharmacotherapeutic group: cytostatic (antimetabolite), ATC code:
L01BC06
Capecitabine is a non-cytotoxic fluoropyrimidine carbamate, which
functions as an orally administered precursor of the
cytotoxic moiety 5-fluorouracil (5-FU). Capecitabine is activated via
several enzymatic steps. The enzyme involved in the
final conversion to 5-FU, thymidine phosphorylase (ThyPase), is found
in tumour tissues, but also in normal tissues, albeit
usually at lower levels. In human cancer xenograft models capecitabine
demonstrated a synergistic effect in combination
with docetaxel, which may be related to the upregulation of thymidine
phosphorylase by docetaxel.
There is evidence that the metabolism of 5-FU in the anabolic pathway
blocks the methylation reaction of deoxy uridylic acid
to thymidylic acid, thereby interfering with the synthesis of
deoxyribonucleic acid (DNA). The incorporation of 5-FU also leads
to inhibition of RNA and protein synthesis. Since DNA and RNA are
essential for cell division and growth, the effect of 5-FU
may be to create a thymidine deficiency that provokes unbalanced
growth and death of a cell. The effects of DNA and RNA
deprivation are most marked on those cells which proliferate more
rapidly and which metabolise 5-FU at a more rapid rate.
Colon and co