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CAPECITABINE ACCORD Film-coated tablets (2018)

Active ingredients: Capecitabine

Product Name and Form

Capecitabine Accord 150 mg film-coated tablets.

Capecitabine Accord 300 mg film-coated tablets.

Capecitabine Accord 500 mg film-coated tablets.

Pharmaceutical form

Film-coated tablet.

Capecitabine Accord 150 mg film-coated tablets: The film-coated tablets are light peach colored, oblong shaped, biconvex, 11.4 mm in length and 5.3 mm in width, debossed with ‘150’ on one side and plain on other side.

Capecitabine Accord 300 mg film-coated tablets: The film-coated tablets are white to off white, oblong shaped, biconvex, 14.6 mm in length and 6.7 mm in width, debossed with ‘300’ on one side and plain on other side.

Capecitabine Accord 500 mg film-coated tablets: The film-coated tablets are peach colored, oblong shaped, biconvex, 15.9 mm in length and 8.4 mm in width, debossed with ‘500’ on one side and plain on other side.

Qualitative and Quantitative Composition

Capecitabine Accord 150 mg film-coated tablets: Each film-coated tablet contains 150 mg of capecitabine.

Capecitabine Accord 300 mg film-coated tablets: Each film-coated tablet contains 300 mg of capecitabine.

Capecitabine Accord 500 mg film-coated tablets: Each film-coated tablet contains 500 mg of capecitabine.

Excipient with known effect:

Capecitabine Accord 150 mg film-coated tablets: Each film-coated tablet contains 7 mg anhydrous lactose.

Capecitabine Accord 300 mg film-coated tablets: Each film-coated tablet contains 15 mg anhydrous lactose

Capecitabine Accord 500 mg film-coated tablets: Each film-coated tablet contains 25 mg anhydrous lactose

For the 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

Capecitabine Accord 150 mg and 500 mg film-coated tablets

Tablet core:

Anhydrous lactose
Microcrystalline cellulose (E460)
Croscarmellose sodium Hypromellose (E5)
Magnesium stearate

Tablet coating:

Hypromellose (6cps)
Talc
Titanium dioxide (E171)
Iron oxide red (E172)
Iron oxide yellow (E172)

Capecitabine Accord 300 mg film-coated tablets

Tablet core:

Anhydrous lactose
Microcrystalline cellulose (E460)
Croscarmellose sodium Hypromellose (E5)
Magnesium stearate

Tablet coating:

Hypromellose (6cps)
Talc
Titanium dioxide (E171)

Pack sizes and Marketing

Aluminium/aluminium or PVC/PVdC/Aluminium blister containing 30, 60 or 120 film-coated tablets. Each pack contains 30, 60 or 120 film-coated tablets.

PVC/PVdC/Aluminium perforated unit dose blister containing 30, 60 or 120 film-coated tablets. Each pack contains 30 × 1, 60 × 1 or 120 × 1 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder
Authorization dates

Accord Healthcare Limited Sage house, 319, Pinner road North Harrow Middlesex HA1 4HF, United Kingdom

Date of first authorisation: 20 April 2012

Date of latest renewal: 09th January 2017

Marketing authorization number:

EU/1/12/762/001-003
EU/1/12/762/004-006
EU/1/12/762/019-021
EU/1/12/762/007-009
EU/1/12/762/010-012
EU/1/12/762/022-024
EU/1/12/762/013-015
EU/1/12/762/016-018
EU/1/12/762/025-027