BLISTEX COLD SORE Cream Ref.[2759] Active ingredients: Docosanol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2017  Publisher: DDD Limited, 94 Rickmansworth Road, Watford, Hertfordshire, WD18 7JJ

Therapeutic indications

Treatment of early stages (prodrome or erythema phase) of recurrent labial herpes simplex infection (cold sores) in immunocompetent adults.

Posology and method of administration

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.

Overdose

Adverse reactions related to overdose by topical application of Blistex Cold Sore Cream are unlikely because of negligible percutaneous absorption. Similarly, poor oral absorption makes the occurrence of adverse reactions unlikely following ingestion of docosanol.

Shelf life

Shelf life: 3 years.

After first opening the container: 6 months.

Special precautions for storage

Do not store above 25°C.

Nature and contents of container

Epoxy-lined aluminium tubes closed with a polyethylene screw cap.

Pack size: 2 g

Special precautions for disposal and other handling

No special requirements.

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