País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
Capecitabine
Fresenius Kabi Deutschland GmbH
L01BC; L01BC06
Capecitabine
150 milligram(s)
Film-coated tablet
Pyrimidine analogues; capecitabine
Not marketed
2012-11-09
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 Leia o documento completo
HealthProductsRegulatoryAuthority 05April2019 CRN008RV0 Page1of22 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Capecitabine150mgfilm-coatedtablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Eachfilm-coatedtabletcontains150 mgcapecitabine. Excipient(s)withknowneffect: 12mglactosemonohydrate(150mgtablet). Forthefulllistofexcipients,seesection6.1. 3 PHARMACEUTICAL FORM Film-coatedtablet. Pinkcoloured,capsuleshaped,biconvex,filmcoatedtablets,debossedwith“150”ononesideandplainonotherside. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS CapecitabineisindicatedfortheadjuvanttreatmentofpatientsfollowingsurgeryofstageIII(Dukes'stageC)coloncancer(see section5.1). Capecitabineisindicatedforthetreatmentofmetastaticcolorectalcancer(seesection 5.1). Capecitabineisindicatedforfirst-linetreatmentofadvancedgastriccancerincombinationwithaplatinum-basedregimen(see section5.1). Capecitabineincombinationwithdocetaxel(seesection5.1)isindicatedforthetreatmentofpatientswithlocallyadvancedor metastaticbreastcancerafterfailureofcytotoxicchemotherapy.Previoustherapyshouldhaveincludedananthracycline. Capecitabineisalsoindicatedasmonotherapyforthetreatmentofpatientswithlocallyadvancedormetastaticbreastcancer afterfailureoftaxanesandananthracycline-containingchemotherapyregimenorforwhomfurtheranthracyclinetherapyis notindicated. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Capecitabineshouldonlybeprescribedbyaqualifiedphysicianexperiencedintheutilisationofanti- Leia o documento completo