BLISTEX COLD SORE

Route of Administration:

Cutaneous use Posology Adults and adolescents aged 12 years and over: Apply a thin film carefully over the entire cold sore 5 times a day (approximately every 3 hours during waking hours). Treatment must begin as soon as possible after the first cold sore symptoms or signs appear (pain, burning/itching/tingling or redness) as efficacy has not been demonstrated when the treatment is initiated at the stage of an already developed blister or ulcer.

Treatment should continue until healing has occurred, usually 4 to 6 days, or for a maximum of 10 days.

Elderly:

No special dose recommendation.

Paediatric population:

The safety and efficacy of Blistex Cold Sore Cream in children aged younger than 12 years have not been established.

Dosage in renal failure:

No dose adjustments necessary due to negligible topical absorption.

Very common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Very rare (<1/10,000) not known (cannot be estimated from the available data). Results from clinical trials of the treatment of recurrent labial herpes simplex demonstrate no difference in the frequency or type of undesirable effects in patients treated with Blistex Cold Sore Cream or placebo.

7% of placebo-treated patients). 3% of placebo- treated patients). Facial oedema has also been reported but these application site adverse reactions are consistent with normal facial reactions experienced with cold sores. Reporting of suspected adverse reactions Reporting suspected adverse actions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard.

Avoid application close to or in the eyes. Should only be used for cold sores on the mouth and face. Must not be used to treat genital or ocular herpes infections Avoid transmitting the virus, particularly when active lesions are present The cream should not be used in immuno compromised patients.

Treatment with the cream should not be initiated at the stage of an already developed blister or ulcer. If the recurrent cold sore is particularly severe, consult doctor. Immunocompromised patients should consult a pharmacist or doctor concerning treatment of any infection, including cold sores.

Pediatric population There is no treatment experience available for the use in children below the age of 12 years and only limited experience in adolescent(aged12-18years). It is recommended that the cream should not be used in children under 12 years.

This formulation contains propylene glycol and may cause skin irritation.

Hypersensitivity to the active substance (docosanol) or to any of the excipients.