• History of severe and unexpected reactions to fluoropyrimidine therapy,
• Hypersensitivity to capecitabine or to any of the excipients listed in section 6.1 or fluorouracil,
• In patients with known dihydropyrimidine dehydrogenase (DPD) deficiency (see section 4.4),
• During pregnancy and lactation,
• In patients with severe leukopenia, neutropenia, or thrombocytopenia,
• In patients with severe hepatic impairment,
• In patients with severe renal impairment (creatinine clearance below 30 ml/min),
• Treatment with sorivudine or its chemically related analogues, such as brivudine (see section 4.5),
• If contraindications exist to any of the medicinal products in the combination regimen, that medicinal product should not be used.