Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
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. |
Each film-coated tablet contains 150 mg capecitabine.
Excipient with known effect: Each film-coated tablet contains 7 mg lactose.
Each film-coated tablet contains 300 mg capecitabine.
Excipient with known effect: Each film-coated tablet contains 15 mg lactose.
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 Tablet coating: Ecansya 150 mg film-coated tablets: Hypromellose (6cps) Ecansya 300 mg film-coated tablets: Hypromellose (6cps) Ecansya 500 mg film-coated tablets: Hypromellose (6cps) |
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.
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
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
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
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
| Drug | Countries | |
|---|---|---|
| ECANSYA | Austria, Germany, Estonia, Finland, Croatia, Ireland, Lithuania, Poland |
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