ECANSYA Film-coated tablet Ref.[49804] Active ingredients: Capecitabine

Source: European Medicines Agency (EU)  Revision Year: 2021  Publisher: KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Product name and form

Ecansya 150 mg film-coated tablets.

Ecansya 300 mg film-coated tablets.

Ecansya 500 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet (tablet).

Ecansya 150 mg film-coated tablets: The tablets are light peach colored, oblong shaped, biconvex tablets of 11.4 mm in length and 5.3 mm in width, debossed with “150” on one side and plain on other side.

Ecansya 300 mg film-coated tablets: The tablets are white to off white, oblong shaped, biconvex tablets of 14.6 mm in length and 6.7 mm in width, debossed with “300” on one side and plain on other side.

Ecansya 500 mg film-coated tablets: The tablets are peach colored, oblong shaped, biconvex tablets of 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

Ecansya 150 mg film-coated tablets

Each film-coated tablet contains 150 mg capecitabine.

Excipient with known effect: Each film-coated tablet contains 7 mg lactose.

Ecansya 300 mg film-coated tablets

Each film-coated tablet contains 300 mg capecitabine.

Excipient with known effect: Each film-coated tablet contains 15 mg lactose.

Ecansya 500 mg film-coated tablets

Each film-coated tablet contains 500 mg capecitabine.

Excipient with known effect: Each film-coated tablet contains 25 mg lactose.

For the 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:

Lactose
Microcrystalline cellulose (E460)
Croscarmellose sodium
Hypromellose (E-5)
Magnesium stearate

Tablet coating:

Ecansya 150 mg film-coated tablets:

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

Ecansya 300 mg film-coated tablets:

Hypromellose (6cps)
Talc
Titanium dioxide (E171)

Ecansya 500 mg film-coated tablets:

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

Pack sizes and marketing

Aluminium/aluminium or PVC/PVdC/aluminium blister containing 10 film-coated tablets. Each pack contains 30, 60 or 120 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Marketing authorization dates and numbers

Ecansya 150 mg film-coated tablets

Aluminium/aluminium blisters:

30 film-coated tablets: EU/1/12/763/001
60 film-coated tablets: EU/1/12/763/002
120 Film-coated tablets: EU/1/12/763/003

PVC/PVdC/aluminium blisters:

30 film-coated tablets: EU/1/12/763/004
60 film-coated tablets: EU/1/12/763/005
120 film-coated tablets: EU/1/12/763/006

Ecansya 300 mg film-coated tablets

Aluminium/aluminium blisters:

30 film-coated tablets: EU/1/12/763/007
60 film-coated tablets: EU/1/12/763/008
120 film-coated tablets: EU/1/12/763/009

PVC/PVdC/aluminium blisters:

30 film-coated tablets: EU/1/12/763/010
60 film-coated tablets: EU/1/12/763/011
120 film-coated tablets: EU/1/12/763/012

Ecansya 500 mg film-coated tablets

Aluminium/aluminium blisters:

30 film-coated tablets: EU/1/12/763/013
60 film-coated tablets: EU/1/12/763/014
120 film-coated tablets: EU/1/12/763/015

PVC/PVdC/aluminium blisters:

30 film-coated tablets: EU/1/12/763/016
60 film-coated tablets: EU/1/12/763/017
120 film-coated tablets: EU/1/12/763/018

Date of first authorisation: 20 April 2012
Date of latest renewal: 9 December 2016

Drugs

Drug Countries
ECANSYA Austria, Germany, Estonia, Finland, Ireland, Lithuania, Poland

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