Capecitabine Accord 300mg film-coated tablets tablets film-coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

capecitabine

Available from:

Accord Healthcare Limited

ATC code:

L01BC06

INN (International Name):

capecitabine

Dosage:

300mg

Pharmaceutical form:

tablets film-coated

Units in package:

(60/1x60/), in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2015-12-11

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
CAPECITABINE ACCORD
150 MG FILM-COATED
TABLETS
CAPECITABINE ACCORD
300 MG FILM-COATED
TABLETS
CAPECITABINE ACCORD
500 MG FILM-COATED
TABLETS
capecitabine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START TAKING THIS MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your
doctor or pharmacist.
•
This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them,
even if their signs of illness are the same as
yours.
•
If you get any side effects talk to your doctor or
pharmacist. This includes any possible side
effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET
1. What Capecitabine Accord is and what it is
used for
2. What you need to know before you take
Capecitabine Accord
3. How to take Capecitabine Accord
4. Possible side effects
5. How to store Capecitabine Accord
6. Contents of the pack and other information 1. WHAT CAPECITABINE ACCORD IS
AND WHAT IT IS USED FOR
Capecitabine Accord belongs to the group of
medicines called "cytostatic medicines", which
stop the growth of cancer cells. Capecitabine
Accord 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).
Capecitabine Accord is used in the treatment of
colon, rectal, gastric, or breast cancers.
Furthermore, Capecitabine Accord is used to
prevent new occurrence of colon cancer after
complete removal of the tumour by surgery.
Capecitabine Accord may be used either alone or
in combination with other medicines. 2. WHAT YOU NEED TO KNOW
BEFORE YOU TAKE CAPECITABINE
ACCORD
DO NOT TAKE CAPECITABINE ACCORD
•
if you are allergic to capecitabine or any of the
other ingredients of this medicine (listed in
section 6). You must inform your doctor if you
know that you have an allergy or overreaction to
this medicine,
•
if you previously

Summary of Product characteristics

26
1.
NAME OF THE MEDICINAL PRODUCT
Capecitabine Accord 300 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 300 mg of capecitabine.
Excipient(s) with known effect
:
Each film-coated tablet contains 15 mg anhydrous lactose
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Capecitabine Accord 300 mg film-coated tablets are white to off white,
oblong shaped, biconvex,
14.6 mm in length and 6.7 mm in width, debossed with ‘300’ on one
side and plain on other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Capecitabine Accord is indicated for the adjuvant treatment of
patients following surgery of stage III
(Dukes’ stage C) colon cancer (see section 5.1).
Capecitabine Accord is indicated for the treatment of metastatic
colorectal cancer (see section 5.1).
Capecitabine Accord is indicated for first-line treatment of advanced
gastric cancer in combination
with a platinum based regimen (see section 5.1).
Capecitabine Accord in combination with docetaxel (see section 5.1) 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. Capecitabine
Accord is also indicated as
monotherapy for the treatment of patients with locally advanced or
metastatic breast cancer after
failure of taxanes and an anthracycline containing chemotherapy
regimen or for whom further
anthracycline therapy is not indicated.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Capecitabine Accord should only be prescribed by a qualified physician
experienced in the utilisation
of antineoplastic medicinal products. Careful monitoring during the
first cycle of treatment is
recommended for all patients..
Treatment should be discontinued if progressive disease or intolerable
toxicity is observed. Standard
and reduced dose calculations according to body surface area for
starting doses of Capecitabine
Accord of 1250 mg/m
2
and 1000