WARTICON Topical cream Ref.[8350] Active ingredients: Podophyllotoxin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Phoenix Labs, Suite 12, Bunkilla Plaza, Bracetown Business Park, Clonee, County Meath, IRELAND

Therapeutic indications

Route of administration: Topical.

For the topical treatment of condylomata acuminata affecting the penis or the external female genitalia.

Posology and method of administration

The affected area should be thoroughly washed with soap and water, and dried prior to application.

Using a fingertip, the cream should be applied twice daily morning and evening (every 12 hours) for 3 consecutive days using only enough cream to just cover each wart. The cream should then be withheld for the next 4 consecutive days.

Application to the surrounding normal tissue should be avoided.

Residual warts should be treated with further courses of twice daily applications for three days at weekly intervals, if necessary for a total of 4 weeks of treatment.

Hands should be washed thoroughly after application.

Paediatric population

The safety and efficacy of topical podophyllotoxin have not been established in children under the age of 18.

Overdose

While serious systemic effects have not been reported with the recommended dosage of topical podophyllotoxin, topical overdosage would be expected to increase systemic absorption of the drug and increase the potential for systemic effects, e.g. altered mental state and bone marrow suppression. Following oral ingestion, podophyllotoxin may also cause severe gastroenteritis.

Treatment

If topical overdosage occurs, podophyllotoxin should be washed immediately from the treatment area and symptomatic and supportive therapy initiated.

Treatment of oral podophyllotoxin poisoning is symptomatic and should include supportive care.

Further management should be as clinically indicated or as recommended by the National Poisons Centre, where available.

Shelf life

2 years.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

A collapsible aluminium tube with imperforate nozzle membrane and internally coated with a protective lacquer. Tube cap of polyethylene with a spike on the upper end aimed to perforate the membrane when opening the tube for the first time. Size 5g and 10g.

Special precautions for disposal and other handling

No special requirements.

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