Zovirax Cold Sore Cream
GlaxoSmithKline Consumer Healthcare Contact details
1. Name of the medicinal product
Zovirax Cold Sore Cream
2. Qualitative and quantitative composition
100mg Aciclovir equivalent to 5% w/w
3. Pharmaceutical form
Cream
4. Clinical particulars
4.1 Therapeutic indications
Zovirax Cold Sore Cream is indicated in adults and children for the treatment of Herpes simplex virus infections of the lips and face (recurrent herpes labialis).

Immunocompromised Patients

Zovirax Cold Sore Cream is not recommended for use in immunocompromised patients. Such patients must be advised to consult a physician concerning the treatment of any infection.
4.2 Posology and method of administration
Route of administration – Topical

Adults and children

Zovirax Cold Sore Cream should be applied five times daily at approximately four hourly intervals, omitting the night time application. Zovirax Cold Sore Cream should be applied to the lesions or impending lesions as soon as possible, preferably during the earliest stages (prodrome or erythema). Treatment can also be started during the later (papule or blister) stages. Treatment should be continued for at least 4 days. If healing has not occurred, treatment may be continued for up to 10 days. If lesions are still present after 10 days, users should be advised to consult a doctor. Users should wash their hands before and after applying the cream, and avoid unnecessary rubbing of the lesions or touching them with a towel, to avoid aggravating or transferring the infection.

Use in the Elderly

No special comment.
4.3 Contraindications
Zovirax Cold Sore Cream is contraindicated in patients known to be hypersensitive to aciclovir, valaciclovir, propylene glycol or any of the excipients of Zovirax Cold Sore Cream
4.4 Special warnings and precautions for use
Zovirax Cold Sore cream should only be used on cold sores on the mouth and face. It is not recommended for application to mucous membranes, such as in the mouth or eye and must not be used to treat genital herpes.

Particular care should be taken to avoid contact with eye. People with particularly severe recurrent herpes labialis should be encouraged to seek medical advice.

Cold sore sufferers should be advised to avoid transmitting the virus, particularly when active lesions are present.

Zovirax cold sore cream is not recommended or use by people who know that they are immunocompromised. Such individuals should be encouraged to consult a physician concerning the treatment of any infection.

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

Ocular herpes

Zovirax Cold Sore Cream must not be used for treatment of ocular herpes infections.

Genital herpes

Zovirax Cold Sore Cream must not be used for treatment of genital herpes.

4.5 Interaction with other medicinal products and other forms of interaction
No clinically significant interactions have been identified.
4.6 Pregnancy and lactation
Systemic administration of aciclovir in internationally accepted standard tests did not produce embryotoxic or teratogenic effects in rats, rabbits or mice.

In a non-standard test in rats, foetal abnormalities were observed, but only following such high subcutaneous doses that maternal toxicity was produced. The clinical relevance of these f