Xeloda 150mg and 500mg Film-coated Tablets

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.

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

Roche Registration Limited
6 Falcon Way
Shire Park
Welwyn Garden City
AL7 1TW
United Kingdom

Marketing authorization dates and numbers

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

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

Date of first authorisation: 02 February 2001

Date of first renewal: 02 February 2006

Drugs

Drug
Countries
Austria, Brazil, Canada, Cyprus, Germany, Spain, Finland, France, Hong Kong, Ireland, Italy, Lithuania, Netherlands, Poland, Singapore, Tunisia, United States