Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2011 Publisher: Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom
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. |
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.
| Active Ingredient | 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 Tablet coating: Hypromellose |
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
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
| 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 |
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