Capecitabine 500 mg film-coated tablets

Země: Irsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktivní složka:

Capecitabine

Dostupné s:

Fresenius Kabi Deutschland GmbH

ATC kód:

L01BC; L01BC06

INN (Mezinárodní Name):

Capecitabine

Dávkování:

500 milligram(s)

Léková forma:

Film-coated tablet

Terapeutické oblasti:

Pyrimidine analogues; capecitabine

Stav Autorizace:

Not marketed

Datum autorizace:

2012-11-09

Informace pro uživatele

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
to the chest jaw and back brought on by physical effort and due to
problems with
the blood flow to the heart)
-
if you have brain diseases (for example. cancer that has spread to the
brain, or
nerve damage (neuropathy)
-
if you have calcium imbalances (seen in blood tests)
-
if you have diabetes
-
if you cannot keep food or water in your body because of severe nausea
and
vomiting
-
if you have diarrhoea
-
if you are or become dehydrated
-
if you have imbalances of ions in your blood (electrolyte imbalances,
seen in tests)
-
if you have a history of eye problems as you may need extra monitoring
of your
eyes
-
if you have a severe skin reaction.
_DPD DEFICIENCY_: DPD deficiency is a rare condition present at birth
that is not usually
associated with health problems unless you receive certain medicines.
If you have
an unrecognised DPD deficiency and take capecitabine, you may
experience severe
3. HOW TO TAKE CAPECITABINE
Always take this medicine exactly as your doctor or pharmacist has
told you. Check
with your doctor or pharmacist if you are not sure.
Capecitabine should only be prescribed by a doctor experienced in the
use of
anticancer medicines.
Capecitabine tablets should be
SWALLOWED WHOLE WITH WATER A

Charakteristika produktu

HealthProductsRegulatoryAuthority
05April2019
CRN008RV0
Page1of22
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Capecitabine500mgfilm-coatedtablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Eachfilm-coatedtabletcontains500 mgcapecitabine.
Excipient(s)withknowneffect:
41 mglactosemonohydrate(500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“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).
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-ne