Virasorb Cold Sore Cream
Thornton & Ross Ltd Contact details
1. Name of the medicinal product
Virasorb Cold Sore Cream

2. Qualitative and quantitative composition
5%w/w Aciclovir.

For excipients, see 6.1

3. Pharmaceutical form
Cream

White to off-white, smooth cream without agglomerates, coarse lumps or contaminations and with characteristic odour.

4. Clinical particulars
4.1 Therapeutic indications
Virasorb Cold Sore Cream is indicated for the treatment of recurrent herpes labialis.

4.2 Posology and method of administration
Dose:

Unless otherwise instructed, apply a thin layer of cream over the site of infection every four hours, five times a day.

Length of Treatment:

The cream should be applied to the lesion or developing lesion as soon as possible after the start of the infection. Treatment with Virasorb Cold Sore Cream is normally continued for five days. If there is no clinical benefit after 5 days, treatment should continue for up to another 5 days. If after ten days there is still no clinical (crusted vesicles, healing of lesions), treatment should be discontinued and patients should consult their physician.

Method of administration:

A cotton bud should be used to apply a sufficient quantity of Virasorb Cold Sore Cream to cover all lesions. The cream should be applied to visibly infected sites (vesicles, swelling, erythema) and the adjoining areas. If hands are used to apply the cream, they should be thoroughly washed before and after application to prevent further infection of the lesions by bacteria and to prevent autoinoculation of the virus to other mucous membrane and cutaneous sites not yet infected.

4.3 Contraindications
Virasorb cream is contraindicated in patients known to be hypersensitive to aciclovir, valaciclovir, propylene glycol or any of the excipients of Virasorb cream

4.4 Special warnings and precautions for use
Cold Sore sufferers should be advised to avoid transmitting the virus by direct contact, particularly when active lesions are present.

Virasorb Cold Sore Cream should not be used on mucous membranes (e.g. oral cavity, eye, vagina) since local reactions may occur. Particular care should be taken to avoid accidental introduction into the eye.

Patients with severe Herpes Labialis should seek medical advice.

In severely immunocompromised patients (e.g. AIDS patients or bone marrow transplant recipients) oral aciclovir dosing should be considered. Such patients should be encouraged to consult their physician concerning the treatment of any infection and before starting treatment with Virasorb Cold Sore Cream.

Virasorb Cold Sore Cream must not be used for treatment of ocular herpes infections or for the treatment of genital herpes.

The excipient propylene glycol can cause skin irritations and the excipient cetyl alcohol can cause local skin reactions (e.g. contact dermatitis).

4.5 Interaction with other medicinal products and other forms of interaction
No clinically significant interactions have been identified.

4.6 Pregnancy and lactation
Pregnancy:

Only about 0.1% of the aciclovir applied to the skin is detectable in the plasma. Concentrations are minimal so that no systemic effect should occur.

The use of aciclovir should be considered only when the potential benefits outweigh the possibility of unknown risks however the systemic exposure to aciclovir from top