Capecitabine Accord tablets film-coated

Nazione: Armenia

Lingua: inglese

Fonte: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Principio attivo:

capecitabine

Commercializzato da:

Accord Healthcare Polska Sp. z o.o.

Codice ATC:

L01BC06

INN (Nome Internazionale):

capecitabine

Dosaggio:

500mg

Forma farmaceutica:

tablets film-coated

Confezione:

(120/1x120/), in blister

Tipo di ricetta:

Prescription

Stato dell'autorizzazione:

Registered

Data dell'autorizzazione:

2021-06-23

Foglio illustrativo

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. (see section 4).
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 over reaction
to this medicine,
•

Scheda tecnica

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Capecitabine Accord 150 mg film-coated tablets
Capecitabine Accord 300 mg film-coated tablets
Capecitabine Accord 500 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Capecitabine Accord 150 mg film-coated tablets
Each film-coated tablet contains 150 mg of capecitabine.
Capecitabine Accord 300 mg film-coated tablets
Each film-coated tablet contains 300 mg of capecitabine.
Capecitabine Accord 500 mg film-coated tablets
Each film-coated tablet contains 500 mg of capecitabine.
Excipient with known effect
_ _
_Capecitabine Accord 150 mg film-coated tablets _
_ _
Each film-coated tablet contains 7 mg anhydrous lactose.
_Capecitabine Accord 300 mg film-coated tablets _
Each film-coated tablet contains 15 mg anhydrous lactose
_Capecitabine Accord 500 mg film-coated tablets _
Each film-coated tablet contains 25 mg anhydrous lactose
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Capecitabine Accord 150 mg film-coated tablets
The film-coated tablets are light peach colored, oblong shaped,
biconvex, 11.4 mm in length and
5.3 mm in width, debossed with ‘150’ on one side and plain on
other side.
Capecitabine Accord 300 mg film-coated tablets
The 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.
Capecitabine Accord 500 mg film-coated tablets
The film-coated tablets are peach colored, oblong shaped, biconvex,
15.9 mm in length and 8.4 mm in
width, debossed with ‘500’ on one side and plain on other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Capecitabine Accord is indicated for the treatment of:
3
-for the adjuvant treatment of patients following surgery of stage III
(Dukes’ stage C) colon cancer
(see section 5.1).
- metastatic colorectal cancer (see section 5.1).
- first-line treatment of advanced gastric cancer in combination with
a platinum bas