Active ingredients: Adefovir dipivoxil
Hepsera 10 mg tablets.
White to off-white, round, flat-faced, bevelled-edge tablets, 7 mm in diameter, debossed with “GILEAD” and “10” on one side and a stylised shape of a liver on the other side.
Each tablet contains 10 mg adefovir dipivoxil.
Excipient(s) with known effect: Each tablet contains 113 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
Adefovir dipivoxil is an oral prodrug of adefovir, an acyclic nucleotide phosphonate analogue of adenosine monophosphate, which is actively transported into mammalian cells where it is converted by host enzymes to adefovir diphosphate. Adefovir diphosphate inhibits viral polymerases by competing for direct binding with the natural substrate (deoxyadenosine triphosphate) and, after incorporation into viral DNA, causes DNA chain termination.
Hepsera is supplied in high-density polyethylene (HDPE) bottles with a child-resistant closure. Each bottle contains 30 tablets, silica gel desiccant and fibre packing material.
The following pack sizes are available: outer cartons containing 1 bottle of 30 tablets and outer cartons containing 90 (3 bottles of 30) tablets. Not all pack sizes may be marketed.
Gilead Sciences Ireland UC, Carrigtohill, County Cork, T45 DP77, Ireland
Date of first authorisation: 06 March 2003
Date of latest renewal: 06 March 2008