FENISTIL COLD SORE Cream

Active ingredients: Penciclovir

Product name and form

Fenistil Cold Sore Cream.

Pharmaceutical Form

Cream.

Smooth white cream of homogeneous appearance.

Qualitative and quantitative composition

Each gram of the cream contains: 10 mg penciclovir.

Excipients with known effect: cetostearyl alcohol, propylene glycol.

For a full list of excipients, see section 6.1.

Active Ingredient
Description

Penciclovir has demonstrated in vivo and in vitro activity against herpes simplex viruses (types 1 and 2) and varicella zoster virus. Penciclovir triphosphate persists in infected cells for more than 12 hours where it inhibits replication of viral DNA and has a half-life of 9, 10 and 20 hours in cells infected with varicella zoster virus, herpes simplex virus type 1 and herpes simplex virus type 2 respectively.

List of Excipients

White soft paraffin
Liquid paraffin
Cetostearyl alcohol
Propylene glycol
Cetomacrogol 1000
Purified water

Pack sizes and marketing

2g aluminium tube.

Marketing authorization holder

Omega Pharma Ltd., 1st Floor, 32 Vauxhall Bridge Road, LONDON, SW1V 2SA, United Kingdom

Marketing authorization dates and numbers

PL 02855/0306

23/08/2006