Source: Υπουργείο Υγείας (CY) Revision Year: 2021 Publisher: Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus
Kapetral 150 mg film-coated tablets.
Kapetral 500 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. Kapetral 150 mg film-coated tablets: Light-peach, oval, film-coated tablets embossed with “150” on one side, of approximate dimensions 11.4 mm x 5.9 mm. Kapetral 500 mg film-coated tablets: Peach, oblong capsule-shaped, film-coated tablets embossed with “500” on one side, of approximate dimensions 17.1 mm x 8.1 mm. |
Kapetral 150 mg film-coated tablets: Each film-coated tablet contains capecitabine 150 mg.
Kapetral 500 mg film-coated tablets: Each film-coated tablet contains capecitabine 500 mg.
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 |
|---|
|
Core: Croscarmellose sodium Film-coating: Hypromellose |
Kapetral 150 mg film-coated tablets: PVC/PVDC-Aluminium and PVC/PE/PVDC-Aluminium blisters. Pack size of 60 tablets.
Kapetral 500 mg film-coated tablets: PVC/PVDC-Aluminium and PVC/PE/PVDC-Aluminium blisters. Pack size of 120 tablets.
Not all pack sizes may be marketed.
Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus
Kapetral 150 mg film-coated tablets: 021625
Kapetral 500 mg film-coated tablets: 021626
Date of first authorization: 21 December 2012
Date of latest renewal: 28 May 2019
| Drug | Countries | |
|---|---|---|
| KAPETRAL | Albania, Cyprus, Croatia, Malta, Singapore |
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