MHRA Launch Consultation Document on P to GSL Switch for Savlon Cold Sore Cream

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Savlon Cold Sore Cream 1% w/w is indicated for the treatment of herpes simplex virus infections of the lips and face (herpes labialis) in adults and children over 12 years of age.

Recurrent herpes simplex labialis is a very common worldwide disease, mostly due to Herpes simplex virus type 1 (HSV-1) with a prevalence of 20-45% in different populations worldwide. The infection is characterised by repeated attacks of encrusted lesions on the lips and around the mouth. Recurrence is a consequence of reactivation of latent virus. Typically, a ‘classical lesion’ begins with the prodromal ‘tingling’ sensation followed by blister, ulcer, then a crust and can take between 5-15 days for resolution. The frequency of attacks can vary between 2 and 10 attacks per year. Although episodes are generally mild in nature, non-serious and self-limiting, the lesion is often painful and disfiguring. The discomfort, cosmetic impact and fear of transmitting the virus to others can lead many sufferers to seek treatment rapidly, with an antiviral medication that can modify the course of infection.

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