SPC: HEPSERA Tablet (2018)

Product Name and Form

Hepsera 10 mg tablets.

Pharmaceutical form

Tablet.

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.

Qualitative and Quantitative Composition

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.

List of excipients

Pregelatinised starch
Croscarmellose sodium
Lactose monohydrate
Talc
Magnesium stearate

Pack sizes and Marketing

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.

Marketing authorization holder
Authorization dates

Gilead Sciences Ireland UC, Carrigtohill, County Cork, T45 DP77, Ireland

Date of first authorisation: 06 March 2003
Date of latest renewal: 06 March 2008

Marketing authorization number:

EU/1/03/251/001
EU/1/03/251/002