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Xeloda 150mg and 500mg Film-coated Tablets (2011)

Active ingredients: Capecitabine

Product Name and Form

Xeloda 150 mg and 500 mg film-coated tablets.

Pharmaceutical form

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.

Qualitative and Quantitative Composition

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.

Chemical substance
Description
Capecitabine

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.

List of excipients

Tablet core:

Anhydrous lactose
Croscarmellose sodium
Hypromellose
Microcrystalline cellulose
Magnesium stearate

Tablet coating:

Hypromellose
Titanium dioxide (E171)
Yellow and red iron oxide (E172)
Talc

Pack sizes and Marketing

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)

Marketing authorization holder
Authorization dates

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

Marketing authorization number:

EU/1/00/163/001 – 150 mg film-coated tablets

EU/1/00/163/002 – 500 mg film-coated tablets