Capecitabine SUN
Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
22-12-2016
Karatteristiċi tal-prodott
(SPC)
22-12-2016
Rapport ta 'Valutazzjoni Pubblika
(PAR)
22-12-2016
Ingredjent attiv:
capecitabine
Disponibbli minn:
Sun Pharmaceutical Industries Europe B.V.
Kodiċi ATC:
L01BC06
INN (Isem Internazzjonali):
capecitabine
Grupp terapewtiku:
capecitabine
Żona terapewtika:
Stomach Neoplasms; Breast Neoplasms; Colonic Neoplasms; Colorectal Neoplasms
Indikazzjonijiet terapewtiċi:
Capecitabine is indicated for the adjuvant treatment of patients following surgery of stage-III (Dukes’ stage-C) colon cancer.Capecitabine is indicated for the treatment of metastatic colorectal cancer.Capecitabine is indicated for first-line treatment of advanced gastric cancer in combination with a platinum-based regimen.Capecitabine 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 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: 3
L-istatus ta 'awtorizzazzjoni:
Withdrawn
Data ta 'l-awtorizzazzjoni:
2013-06-21
Fuljett ta 'informazzjoni
62
B. PACKAGE LEAFLET
Medicinal product no longer authorised
63
PACKAGE LEAFLET: INFORMATION FOR THE USER
CAPECITABINE SUN 150 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 SUN is and what it is used for
2.
What you need to know before you take Capecitabine SUN
3.
How to take Capecitabine SUN
4.
Possible side effects
5.
How to store Capecitabine SUN
6.
Contents of the pack and other information
1.
WHAT CAPECITABINE SUN IS AND WHAT IT IS USED FOR
Capecitabine SUN belongs to the group of medicines called "cytostatic
agents", which stop the growth
of cancer cells. Capecitabine SUN contains capecitabine, which itself
is not a cytostatic agent. Only
after being absorbed by the body is it changed into an active
anti-cancer agent (more in tumour tissue
than in normal tissue).
Capecitabine SUN is used in the treatment of colon, rectal, gastric,
or breast cancers.
Furthermore, Capecitabine SUN is used to prevent new occurrence of
colon cancer after complete
removal of the tumour by surgery.
Capecitabine SUN may be used either alone or in combination with other
medicines.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CAPECITABINE SUN
DO NOT TAKE CAPECITABINE SUN
-
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 to capecitabine.
-
if you previously have had severe reactions to fluoropyrimidine
therapy (a group of anticancer
medicines such
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Karatteristiċi tal-prodott
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Capecitabine SUN 150 mg film-coated tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 150 mg of capecitabine.
Excipient(s) with known effect:
Each film-coated tablet contains 20.69 mg anhydrous lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Capecitabine SUN 150 mg film-coated tablets are light peach coloured,
oval, biconvex, 11.
5 mm
x
5.7 mm tablets with inscription ‘150’on one side and plain on
other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Capecitabine is indicated for the adjuvant treatment of patients
following surgery of stage III (Dukes’
stage C) colon cancer (see section 5.1).
Capecitabine is indicated for the treatment of metastatic colorectal
cancer (see section 5.1).
Capecitabine is indicated for first-line treatment of advanced gastric
cancer in combination with a
platinum-based regimen (see section 5.1).
Capecitabine 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 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 should only be prescribed by a qualified physician
experienced in the utilisation of
anti-neoplastic 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 of
1250 m
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