Capecitabine Medac
Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
31-03-2023
Karatteristiċi tal-prodott
(SPC)
31-03-2023
Rapport ta 'Valutazzjoni Pubblika
(PAR)
05-08-2020
Ingredjent attiv:
capecitabine
Disponibbli minn:
medac Gesellschaft für klinische Spezialpräparate mbH
Kodiċi ATC:
L01BC06
INN (Isem Internazzjonali):
capecitabine
Grupp terapewtiku:
Antineoplastic agents
Żona terapewtika:
Colorectal Neoplasms
Indikazzjonijiet terapewtiċi:
Capecitabine Medac is indicated for the adjuvant treatment of patients following surgery of stage-III (Dukes’ stage-C) colon cancer.Capecitabine Medac is indicated for the treatment of metastatic colorectal cancer.Capecitabine Medac is indicated for first-line treatment of advanced gastric cancer in combination with a platinum-based regimen.Capecitabine Medac 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.Capecitabine Medac 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.
Sommarju tal-prodott:
Revision: 13
L-istatus ta 'awtorizzazzjoni:
Authorised
Data ta 'l-awtorizzazzjoni:
2012-11-19
Fuljett ta 'informazzjoni
42
B. PACKAGE LEAFLET
43
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CAPECITABINE MEDAC 150 MG FILM
-
COATED TABLETS
CAPECITABINE MEDAC 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 medac is and what it is used for
2.
What you need to know before you take Capecitabine medac
3.
How to take Capecitabine medac
4.
Possible side effects
5.
How to store Capecitabine medac
6.
Contents of the pack and other information
1.
WHAT CAPECITABINE MEDAC IS AND WHAT IT IS USED FOR
Capecitabine medac belongs to the group of medicines called
"cytostatic medicines", which stop the
growth of cancer cells. Capecitabine medac 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 medac is used in the treatment of colon, rectal, gastric,
or breast cancers.
Furthermore, Capecitabine medac is used to prevent new occurrence of
colon cancer after complete
removal of the tumour by surgery.
Capecitabine medac may be used either alone or in combination with
other medicines.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CAPECITABINE MEDAC
DO NOT TAKE CAPECITABINE MEDAC
•
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,
•
if you previously have had sev
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Karatteristiċi tal-prodott
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Capecitabine medac 150 mg film-coated tablets
Capecitabine medac 500 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Capecitabine medac 150 mg film-coated tablets
Each film-coated tablet contains 150 mg capecitabine.
Capecitabine medac 500 mg film-coated tablets
Each film-coated tablet contains 500 mg capecitabine.
Excipients with known effect
_Capecitabine medac 150 mg film-coated tablets _
Each film-coated tablet contains 7 mg anhydrous lactose.
_Capecitabine medac 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 (tablet).
Capecitabine medac 150 mg film-coated tablets
The film-coated tablets are light peach coloured, oblong shaped,
biconvex tablets of 11.4 mm in length
and 5.3 mm in width, debossed with ‘150’ on one side and plain on
other side.
Capecitabine medac 500 mg film-coated tablets
The film-coated tablets are peach coloured, oblong shaped, biconvex
tablets of 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 medac is indicated:
•
for the adjuvant treatment of patients following surgery of stage III
(Dukes’ stage C) colon
cancer (see section 5.1).
•
for the treatment of metastatic colorectal cancer (see section 5.1).
•
for first-line treatment of advanced gastric cancer in combination
with a platinum based regimen
(see section 5.1).
•
in combination with docetaxel (see section 5.1) for the treatment of
patients with locally
advanced or metastatic breast cancer after failure of cytotoxic
chemotherapy. Previous therapy
should have included an anthracycline.
3
•
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 a
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