XELODA Film-coated tablet Ref.[2609] Active ingredients: Capecitabine

Source: European Medicines Agency (EU)  Revision Year: 2025  Publisher: CHEPLAPHARM Arzneimittel GmbH, Ziegelhof 24, 17489 Greifswald, Germany

Product name and form

Xeloda 150 mg film-coated tablets.

Xeloda 500 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

Xeloda 150 mg film-coated tablets:

The film-coated tablets are light peach tablets of biconvex, oblong shape with the marking '150' on the one side and 'Xeloda' on the other side

Xeloda 500 mg film-coated tablets:

The film-coated tablets are peach tablets of biconvex, oblong shape with the marking '500' on the one side and 'Xeloda' on the other side.

Qualitative and quantitative composition

Xeloda 150 mg film-coated tablets:

Each film-coated tablet contains 150 mg capecitabine.

Xeloda 500 mg film-coated tablets:

Each film-coated tablet contains 500 mg capecitabine.

Excipient(s) with known effect:

Xeloda 150 mg film-coated tablets: Each 150 mg film-coated tablet contains 15.6 mg anhydrous lactose.

Xeloda 500 mg film-coated tablets: Each 500 mg film-coated tablet contains 52 mg anhydrous lactose.

For the full list of excipients, see section 6.1.

Active Ingredient

Capecitabine is a non-cytotoxic fluoropyrimidine carbamate, which functions as an orally administered precursor of the cytotoxic moiety 5-fluorouracil (5-FU). Capecitabine is activated via several enzymatic steps.
List of Excipients

Tablet core:

Anhydrous lactose
Croscarmellose sodium
Hypromellose (3 mPa.s)
Microcrystalline cellulose
Magnesium stearate

Tablet coating:

Hypromellose
Titanium dioxide
Yellow iron oxide
Red iron oxide
Talc

Pack sizes and marketing

PVC/PVDC blisters.

Xeloda 150 mg film-coated tablets:

Pack size of 60 film-coated tablets (6 blisters of 10 tablets).

Xeloda 500 mg film-coated tablets:

Pack size of 120 film-coated tablets (12 blisters of 10 tablets).

Marketing authorization holder

CHEPLAPHARM Arzneimittel GmbH, Ziegelhof 24, 17489 Greifswald, Germany

Marketing authorization dates and numbers

EU/1/00/163/001
EU/1/00/163/002

Date of first authorisation: 02 February 2001
Date of latest renewal: 09 February 2006

Drugs

Drug Countries
XELODA Albania, Austria, Brazil, Canada, Cyprus, Germany, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Italy, Japan, Lithuania, Mexico, Netherlands, Poland, Singapore, Tunisia, United States, South Africa
 
Next: Usage >

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.

⇈