Capecitabine Cipla 500mg Film-coated Tablets

Maa: Malta

Kieli: englanti

Lähde: Medicines Authority

Aktiivinen ainesosa:

CAPECITABINE

Saatavilla:

Cipla Europe N.V. Uitbreidingstraat 80, 2600 Antwerp, Belgium

ATC-koodi:

L01BC06

INN (Kansainvälinen yleisnimi):

CAPECITABINE 500 mg

Lääkemuoto:

FILM-COATED TABLET

Koostumus:

CAPECITABINE 500 mg

Prescription tyyppi:

POM

Terapeuttinen alue:

ANTINEOPLASTIC AGENTS

Valtuutuksen tilan:

Withdrawn

Valtuutus päivämäärä:

2015-06-17

Pakkausseloste

PACKAGE LEAFLET: INFORMATION FOR THE USER
CAPECITABINE CIPLA 150 MG FILM-COATED TABLETS
CAPECIYABINE CIPLA 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. Do not pass it on to
others. It may harm them, even if
their symptoms are the same as yours.
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please
tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What Capecitabine Cipla is and what it is used for
2.
Before you take Capecitabine Cipla
3.
How to take Capecitabine Cipla
4.
Possible side effects
5.
How to store Capecitabine Cipla
6.
Further Information
1.
WHAT CAPECITABINE CIPLA IS AND WHAT IT IS USED FOR
Capecitabine Cipla belongs to the group of medicines called
"cytostatic agents", which stop the
growth of cancer cells. Capecitabine Cipla contains 150 mg / 500 mg
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 Cipla is prescribed by doctors for the treatment of
colon, rectal, gastric, or breast
cancers.
Furthermore, Capecitabine Cipla is prescribed by doctors to prevent
new occurrence of colon cancer
after complete removal of the tumour by surgery.
Capecitabine Cipla may be used either alone or in combination with
other
agents
.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CAPECITABINE CIPLA
DO NOT TAKE CAPECITABINE CIPLA:

if you are allergic (hypersensitive) to capecitabine or any of the
other ingredients of
Capecitabine Cipla
. You must inform your doctor if you know that you have an allergy or
over-
reaction to Capecitabine tablet.

if you are pregnant or nursing,

if you have blood disorders,

if you have liver a

Valmisteyhteenveto

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1.
NAME OF THE MEDICINAL PRODUCT:
Capecitabine Cipla 150 mg film- coated tablets
Capecitabine Cipla 500 mg film- coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION:
For 150 mg strength:
Each film-coated tablet contains 150 mg capecitabine.
Excipient with known effect: 12.3 mg lactose monohydrate.
For 500 mg strength:
Each film-coated tablet contains 500 mg capecitabine.
Excipient with known effect: 41 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM:
Film-coated Tablet
For 150 mg strength:
Pink colored, capsule shaped, biconvex, film-coated tablets debossed
with “150” on one side and
plain on other side.
For 500 mg strength:
Pink colored, capsule shaped, biconvex, film-coated tablets debossed
with “500” 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).
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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 agents. Capecitabine tablets should be swallowed with
water within 30 minutes
after a meal. Treatment should