Capecitabine 150 mg film-coated tablets

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

Capecitabine

可用日期:

Fresenius Kabi Oncology Plc

ATC代码:

L01BC; L01BC06

INN（国际名称）:

Capecitabine

剂量:

150 milligram(s)

药物剂型:

Film-coated tablet

处方类型:

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

治疗领域:

Pyrimidine analogues; capecitabine

授权状态:

Not marketed

授权日期:

2012-11-09

资料单张

CAPECITABINE - PACK INSERT - IRL+GBR
(Travesh Sharma) D:\Europe\Capecitabine\Ireland + UK\28 Nov
2013\Capecitabine - Pack Insert - IRL+GBR.indd
SIZE:
450 X 210 MM
4 AUGUST 2014 10:27 AM
VER. 09
TIMES NEW ROMAN 8 PTS.
Black
xxxxx
xxxxxxxxxx
V004
CAPECITABINE
FILM-COATED TABLETS
xxxxxx / xxxxxxxxxx / V004
TEMP
CAPECITABINE
FILM-COATED TABLETS
xxxxxx / xxxxxxxxxx / V004
TEMP
PACKAGE LEAFLET: INFORMATION FOR THE USER
CAPECITABINE 150 MG FILM-COATED TABLETS
CAPECITABINE 500 MG FILM-COATED TABLETS
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.
IN THIS LEAFLET:
1.-- What-Capecitabine-is-and-what-it-is-used-for
2.-- What-you-need-to-know-before-you-take-Capecitabine
3.-- How-to-take-Capecitabine
4.-- Possible-side-effects
5.-- How-to-store-Capecitabine
6.-- Contents-of-the-pack-and-other-information
1.
WHAT CAPECITABINE IS AND WHAT IT IS USED FOR
Capecitabine-belongs-to-the-group-of-medicines-called-“cytostatic-medicine”,-which-
stop-the-growth-of-cancer-cells.--Capecitabine-film-coated-tablets-contains-150-mg-
or-500-mg-capecitabine,-which-itself-is-not-a-cytostatic-medicine.-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--is-used-in-the-treatment-of-colon,-rectal,-gastric,-or-breast-cancers.-
Furthermore,-capecitabine-is-used-to-prevent-new-occurrence-of-colon-cancer-after-
complete-removal-of-the-tumour-by-surgery.
Capecitabine-may-be-used-either-alone-or-in-combination-with-other-agents.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CAPE

产品特点

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Capecitabine 150 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 150 mg capecitabine.
Excipient (s) with known effect:
12 mg lactose monohydrate (150 mg tablet).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Pink coloured, capsule shaped, biconvex, film coated tablets, debossed
with “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-
neoplasticmedicinal 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.
Posology
Recommended posology (see section 5.1)
Monotherapy
_Colon,