Active ingredients: Capecitabine
Xeloda 150 mg and 500 mg film-coated tablets.
Film-coated tablet.
Light peach film-coated tablet of biconvex, oblong shape with the marking ‘150’ on the one side and 'Xeloda' on the other side.
Peach film-coated tablet of biconvex, oblong shape with the marking ‘500’ on the one side and 'Xeloda' on the other side.
150 mg or 500 mg capecitabine.
Excipient: 15.6 mg anhydrous lactose (150 mg tablet).
Excipient: 52 mg anhydrous lactose (500 mg tablet).
For a full list of excipients, see section 6.1.
Capecitabine is a non-cytotoxic fluoropyrimidine carbamate, which functions as an orally administered precursor of the cytotoxic moiety 5-fluorouracil (5-FU). There is evidence that the metabolism of 5-FU in the anabolic pathway blocks the methylation reaction of deoxyuridylic acid to thymidylic acid, thereby interfering with the synthesis of deoxyribonucleic acid (DNA). The incorporation of 5-FU also leads to inhibition of RNA and protein synthesis.
Tablet core:
Anhydrous lactose
Croscarmellose sodium
Hypromellose
Microcrystalline cellulose
Magnesium stearate
Tablet coating:
Hypromellose
Titanium dioxide (E171)
Yellow and red iron oxide (E172)
Talc
Nature: PVC/PVDC blisters
Content:
150 mg: 60 film-coated tablets (6 blisters of 10 tablets)
500 mg: 120 film-coated tablets (12 blisters of 10 tablets)
Roche Registration Limited
6 Falcon Way
Shire Park
Welwyn Garden City
AL7 1TW
United Kingdom
Date of first authorisation: 02 February 2001
Date of first renewal: 02 February 2006
EU/1/00/163/001 – 150 mg film-coated tablets
EU/1/00/163/002 – 500 mg film-coated tablets