Ecansya (previously Capecitabine Krka)

Land: Den Europæiske Union

Sprog: engelsk

Kilde: EMA (European Medicines Agency)

Aktiv bestanddel:

capecitabine

Tilgængelig fra:

Krka, d.d., Novo mesto

ATC-kode:

L01BC06

INN (International Name):

capecitabine

Terapeutisk gruppe:

Antineoplastic agents

Terapeutisk område:

Colonic Neoplasms; Breast Neoplasms; Colorectal Neoplasms; Stomach Neoplasms

Terapeutiske indikationer:

Ecansya is indicated for the adjuvant treatment of patients following surgery of stage-III (Dukes’ stage-C) colon cancer.Ecansya is indicated for the treatment of metastatic colorectal cancer.Ecansya is indicated for first-line treatment of advanced gastric cancer in combination with a platinum-based regimen.Ecansya 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. Ecansya 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.

Produkt oversigt:

Revision: 15

Autorisation status:

Authorised

Autorisation dato:

2012-04-20

Indlægsseddel

42
B. PACKAGE LEAFLET
43
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ECANSYA 150 MG FILM-COATED TABLETS
ECANSYA 300 MG FILM-COATED TABLETS
ECANSYA 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 Ecansya is and what it is used for
2.
What you need to know before you take Ecansya
3.
How to take Ecansya
4.
Possible side effects
5.
How to store Ecansya
6.
Contents of the pack and other information
1.
WHAT ECANSYA IS AND WHAT IT IS USED FOR
Ecansya belongs to the group of medicines called "cytostatic
medicines", which stop the growth of
cancer cells. Ecansya 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).
Ecansya is used in the treatment of colon, rectal, gastric, or breast
cancers.
Furthermore, Ecansya is used to prevent new occurrence of colon cancer
after complete removal of the
tumour by surgery.
Ecansya may be used either alone or in combination with other
medicines.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ECANSYA
DO NOT TAKE ECANSYA
-
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 severe reactions to fluoropyrimidine
therapy (a group of anticancer
medicines, such as fluorouracil),
-
if you are pregnant or breast-feedi

Produktets egenskaber

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Ecansya 150 mg film-coated tablets
Ecansya 300 mg film-coated tablets
Ecansya 500 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ecansya 150 mg film-coated tablets
Each film-coated tablet contains 150 mg capecitabine.
_Excipient with known effect_
Each film-coated tablet contains 7 mg lactose.
Ecansya 300 mg film-coated tablets
Each film-coated tablet contains 300 mg capecitabine.
_Excipient with known effect_
Each film-coated tablet contains 15 mg lactose.
Ecansya 500 mg film-coated tablets
Each film-coated tablet contains 500 mg capecitabine.
_Excipient with known effect_
Each film-coated tablet contains 25 mg lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Ecansya 150 mg film-coated tablets
The tablets are light peach colored, 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.
Ecansya 300 mg film-coated tablets
The tablets are white to off white, oblong shaped, biconvex tablets of
14.6 mm in length and 6.7 mm
in width, debossed with "300" on one side and plain on other side.
Ecansya 500 mg film-coated tablets
The tablets are peach colored, 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
Ecansya is indicated for the treatment of:
-
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).
3
-
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.
-
as