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capecitabine

Xeloda · ATC code L01BC06

Also known as: Capecitabin · Brand names: Xeloda, Capecel, Capecitabin Sandoz, Capecitabin Al, Capecitabin Amarox, Capecitabin Beta, Capecitabin Cell Pharm, Capecitabin Glenmark, Capecitabin Hexal, Capetabin, Kapeda, Xeltabin

Key facts
Active substance
capecitabine
Drug class
Antimetabolite
ATC code
L01BC06
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Xeloda 150 mg film-coated tablets. / Xeloda 500 mg film-coated tablets.
Marketing authorisation holder
CHEPLAPHARM Arzneimittel GmbH
Information as of
2026-10-27

Key facts

Capecitabine (Xeloda) is an oral fluoropyrimidine cytotoxic agent. It is used in colon, colorectal, gastric and breast cancer, alone or in combination.

What it is used for

  • Adjuvant treatment after surgery of stage III (Dukes' stage C) colon cancer
  • Metastatic colorectal cancer
  • First-line treatment of advanced gastric cancer with a platinum-based regimen
  • Locally advanced or metastatic breast cancer: with docetaxel after failure of anthracycline-containing chemotherapy, or as monotherapy after failure of taxanes and an anthracycline

Dosing

  • Monotherapy (colon, colorectal, breast): starting dose 1,250 mg/m² twice daily for 14 days, followed by a 7-day rest
  • Combination therapy (colon, colorectal, gastric): 800–1,000 mg/m² twice daily for 14 days with a 7-day rest, or 625 mg/m² twice daily given continuously
  • With irinotecan: 800 mg/m² twice daily for 14 days
  • With docetaxel (breast cancer): 1,250 mg/m² twice daily for 14 days, then a 7-day rest
  • Adjuvant stage III colon cancer: a total of 6 months
  • Dose modifications for toxicity and body-surface-area tables: see the full product information

Contraindications

  • History of severe and unexpected reactions to fluoropyrimidines; hypersensitivity to capecitabine or fluorouracil
  • Known complete DPD deficiency
  • Pregnancy and lactation
  • Severe leukopenia, neutropenia or thrombocytopenia; severe hepatic impairment
  • Severe renal impairment (creatinine clearance below 30 mL/min)
  • Recent or concomitant brivudine treatment

Important warnings

  • Dose-limiting toxicities: diarrhoea, abdominal pain, nausea, stomatitis, hand-foot syndrome
  • Monitor severe diarrhoea carefully and replace fluids and electrolytes if dehydration occurs
  • Careful monitoring during the first treatment cycle is recommended
  • Cardiotoxicity and thrombosis/embolism may occur

Side effects

  • Most common: diarrhoea, nausea, vomiting, abdominal pain, stomatitis
  • Hand-foot syndrome (palmar-plantar erythrodysesthesia)
  • Fatigue, asthenia, anorexia
  • Cardiotoxicity, thrombosis/embolism, worsening of pre-existing renal dysfunction

Interactions

  • Brivudine: potentially fatal increase in fluoropyrimidine toxicity; at least a 4-week wait after brivudine before starting capecitabine

Pregnancy and breastfeeding

  • Contraindicated during pregnancy and lactation
  • Effective contraception for women during treatment and for 6 months after the last dose; men with female partners for 3 months after

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

Common questions – ask Medelix

For patients

Package leaflet, verbatim

Package leaflet for patients →

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

Source: European Medicines Agency (EMA), product information

Austria

  • CapecelG.L. Pharma Gmbh · 1 register entry
  • Capecitabin SandozSandoz Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Germany

  • Capecitabin AlAliud Pharma Gmbh · 1 register entry
  • Capecitabin AmaroxAmarox Pharma Gmbh · 1 register entry
  • Capecitabin BetaBetapharm Arzneimittel Gmbh · 1 register entry
  • Capecitabin Cell PharmStadapharm Gmbh · 1 register entry
  • Capecitabin GlenmarkGlenmark Arzneimittel Gmbh · 1 register entry
  • Capecitabin HexalHexal Ag · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Turkey

  • CapetabinDEM İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
  • KapedaKOÇAK FARMA İLAÇ VE KİMYA SAN. A.Ş. · 2 register entries
  • XeltabinTEVA İLAÇ SAN. VE TİC. A.Ş. · 2 register entries

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 25 more European countries
Bulgaria
Капецитабин Алуфарма, Капецитабин Зентива К.С
Croatia
Kapecitabin Jgl, Kapecitabin Sandoz, Kapetral, Xalvobin
Cyprus
Capecitabine Koanaa, Kapetral
Czechia
Capecitabine
Denmark
Capecitabin Stada, Capecitabin Zentiva
Estonia
Capecitabine Zentiva
Finland
Capecitabine Orion
France
Capecitabine Arrow, Capecitabine Biogaran, Capecitabine Eg, Capecitabine Sandoz, Capecitabine Viatris, Capecitabine Zentiva
Greece
Capecitabine Mylan, Capibine, Preveloda, Xelazor, Zerectum
Hungary
Capecitabin Onkogen, Capecitabine Pharmacenter
Iceland
Capecitabine Accord, Capecitabine Medac, Capecitabine Teva, Capecitabine Zentiva K.S., Ecansya, Xeloda
Italy
Capecitabina Mylan, Capecitabina Zentiva
Latvia
Capecitabine Zentiva
Liechtenstein
Capecitabine Accord, Capecitabine Medac, Capecitabine Teva, Xeloda
Lithuania
Capecitabine Zentiva
Malta
Capecitabine Pharmacare, Kapetral
Netherlands
Capecitabine Amarox, Capecitabine Cf, Capecitabine Glenmark, Capecitabine Sandoz, Coloxet
Norway
Capecitabine Accord, Capecitabine Medac, Capecitabine Teva, Ecansya, Xeloda
Poland
Capecitabine Glenmark
Portugal
Capecitabina Aurovitas, Capecitabina Farmoz, Capecitabina Labosuan, Capecitabina Normon, Capecitabina Pharmacare, Zerectum
Romania
Capecitabină Dr. Reddy's, Cerex
Slovakia
Capecitabine Pharmacenter, Capecitabine Pharmagen, Capecitabine Stada, Coloxet
Slovenia
Kapecitabin Fresenius Kabi
Spain
Capecitabina Glenmark, Capecitabina Kern Pharma, Capecitabina Normon, Capecitabina Pharmakern, Capecitabina Tarbis, Xelcip
Sweden
Capecitabin Stada, Capecitabine Orion, Capecitabine Sandoz, Capecitabine Zentiva

EMA – Article 57 product data (EU/EEA), 2026-10-28

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

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Sources

  1. European Medicines Agency. Xeloda – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/xeloda-epar-product-information_en.pdf
  2. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  3. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  4. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  5. Wikidata (CC0): ATC L01BC.

Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.