Capecitalox 150 mg Filmdragerad tablett

Land: Sverige

Språk: svenska

Källa: Läkemedelsverket (Medical Products Agency)

Aktiva substanser:

kapecitabin

Tillgänglig från:

Viatris Limited

ATC-kod:

L01BC06

INN (International namn):

capecitabine

Dos:

150 mg

Läkemedelsform:

Filmdragerad tablett

Sammansättning:

kapecitabin 150 mg Aktiv substans

Klass:

Apotek

Receptbelagda typ:

Receptbelagt

Terapiområde:

Kapecitabin

Produktsammanfattning:

Förpacknings: Blister, 60 tabletter; Blister, 60 x 1 tabletter (endos)

Bemyndigande status:

Avregistrerad

Tillstånd datum:

2012-11-16

Bipacksedel

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CAPECITALOX 150 MG FILM-COATED TABLETS
CAPECITALOX 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 Capecitalox is and what it is used for
2.
What you need to know before you take Capecitalox
3.
How to take Capecitalox
4.
Possible side effects
5.
How to store Capecitalox
6.
Contents of the pack and other information
1.
WHAT CAPECITALOX IS AND WHAT IT IS USED FOR
Capecitalox belongs to the group of medicines called "cytostatic
medicines", which stop the
growth of cancer cells. Capecitalox contains 150 mg 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).
Capecitalox belongs to the group of medicines called "cytostatic
medicines", which stop the
growth of cancer cells. Capecitalox contains 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 medicine (more in tumour tissue than in normal tissue).
Capecitalox is used in the treatment of colon, rectal, gastric, or
breast cancers. Furthermore,
Capecitalox is used to prevent new occurrence of colon cancer after
complete removal of the
tumour by surgery.
Capecitalox may be used either alone or in combination with other
medicines.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CAPECITALOX
DO NOT TAKE CAPECITALOX:
-
if you are allergic to capecitabi

Produktens egenskaper

Produktinformationen för Capecitalox 150 mg filmdragerad tablett,
MTnr 46941 och
500 mg filmdragerad tablett, MTnr 46942, gäller vid det tillfälle
då läkemedlet
godkändes. Informationen kommer inte att uppdateras eftersom
läkemedlet inte
marknadsförs i Sverige. Av samma anledning finns inte någon svensk
produktinformation.
Den engelska produktinformationen kommer dock att uppdateras för de
produkter där
Sverige är referensland.
Om läkemedelsnamnet i följande produktinformation inte stämmer med
namnet på
dokumentet, beror det på att läkemedlet i Sverige är godkänt under
ett annat namn.
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Capecitalox 150 mg film-coated tablets.
Capecitalox 500 mg film-coated tablets.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 150 mg capecitabine.
Each film-coated tablet contains 500 mg capecitabine.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet
150 mg tablets: Light-peach oval film-coated tablets embossed with
“150” on one
side. Of approximate dimensions 11.4 mm x 5.9 mm.
500 mg tablets: Peach, oblong capsule-shaped, film-coated tablets
embossed with
“500” on one side. Of approximate dimensions 17.1 mm x 8.1 mm.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Capecitalox is indicated for the adjuvant treatment of patients
following surgery of
stage III (Dukes’ stage C) colon cancer (see section 5.1).
Capecitalox is indicated for the treatment of metastatic colorectal
cancer (see section
5.1).
Capecitalox
is
indicated
for
first-line
treatment
of
advanced
gastric
cancer
in
combination with a platinum-based regimen (see section 5.1).
Capecitalox 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.
Capecitalox is also indicated as monotherapy for the treatment of
patients with loca