CAPECITABINE ACTAVIS 150 Milligram Film Coated Tablet

国: アイルランド

言語: 英語

ソース: HPRA (Health Products Regulatory Authority)

有効成分:

CAPECITABINE

から入手可能:

Actavis Group PTC ehf

ATCコード:

L01BC06

INN（国際名）:

CAPECITABINE

投薬量:

150 Milligram

医薬品形態:

Film Coated Tablet

処方タイプ:

Product subject to prescription which may not be renewed (A)

治療領域:

Pyrimidine analogues

認証ステータス:

Authorised

承認日:

2012-09-07

情報リーフレット

CAPECITABINE ACTAVIS 150 MG FILM-COATED TABLETS
CAPECITABINE ACTAVIS 500 MG FILM-COATED TABLETS
PACKAGE LEAFLET: INFORMATION FOR THE USER
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 ACTAVIS IS AND WHAT
IT IS USED FOR
2
WHAT YOU NEED TO KNOW BEFORE YOU
TAKE CAPECITABINE ACTAVIS
3
HOW TO TAKE CAPECITABINE ACTAVIS
4
POSSIBLE SIDE EFFECTS
5
HOW TO STORE CAPECITABINE ACTAVIS
6
CONTENTS OF THE PACK AND OTHER
INFORMATION
1
WHAT CAPECITABINE ACTAVIS IS AND WHAT
IT IS USED FOR
Capecitabine Actavis belongs to the group of
medicines called “cytostatic medicines”, which stop
the growth of cancer cells. Capecitabine Actavis
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 Actavis is used in the treatment of
colon, rectal, gastric, or breast cancers. Furthermore,
Capecitabine Actavis is used to prevent new
occurrence of colon cancer after complete removal
of the tumour by surgery.
Capecitabine Actavis may be used either alone or in
combination with other medicines.
2 WHAT YOU NEED TO KNOW BEFORE YOU
TAKE CAPECITABINE ACTAVIS
DO NOT TAKE CAPECITABINE ACTAVIS:
• 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 sever

製品の特徴

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Capecitabine Actavis 150 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 150 mg capecitabine.
Excipient with known effect: 12.3 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Pink coloured, capsule shaped, biconvex, film coated tablets (approx.
11.1 mm x 5.6 mm), debossed with “150”on one
side and plain on other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Capecitabine 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).
first
-
line treatment of advanced gastric cancer in combination with a
platinumbased 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.
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 mg/m
2
and 1000 mg/m
2
are
provided in tables 1 and 2, respectively.
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