Warticon 0.15% w/w Cream

Podophyllotoxin 1.5 mg/g (0.15% w/w).

For excipients see 6.1

Topical cream

A homogenous white cream.

Route of Administration: Topical

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

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

Using a fingertip, the cream is applied twice daily for 3 days using only enough cream to just cover each wart.

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.

Where lesions are greater than 4 cm² , it is recommended that treatment takes place under the direct supervision of medical staff.

Known hypersensitivity to any of the ingredients

Open wounds eg. Following surgical procedures.

Use in children.

Hypersensitivity to podophyllotoxin.

Concomitant use with other podophyllotoxin containing preparations.

Pregnancy and lactation.

Avoid contact with eyes. Should the cream accidentally come into the eye, the eye should be thoroughly rinsed with water.

The hands should be thoroughly washed after each application. Prolonged contact with healthy skin must be avoided since the cream contains an active pharmaceutical substance which could be harmful on healthy skin.

None presently known.

The product is not for use in pregnancy or lactation.

Reproduction toxicity studies in animals have not given evidence of an increased incidence of foetal damage or other deleterious effects on the reproductive process. However, since podophyllotoxin is a mitosis inhibitor, Warticon Cream should not be used during pregnancy or lactation.

It is not known if the substance is excreted into breast milk.

Observations in man indicate that podophyllotoxin, a crude mixture of lignans, can be harmful to pregnancy. Such observations have not been reported in patients treated with podophyllotoxin.

None presently known.

Local irritation may occur on the second or third day of application associated with the start of wart necrosis. In most cases the reactions are mild. Tenderness, itching, smarting, erythema, superficial epithelial ulceration and balanoposthitis have been reported. Local irritation decreases after treatment.

There have been no reported overdosages with Warticon cream. However, excessive use of podophyllotoxin 0.5% solution has been reported as causing two cases of severe local reactions. In cases of excessive use of Warticon cream resulting in severe local reaction, the treatment should be stopped, the area washed and symptomatic treatment introduced.

No specific antidote is known. In the event of accidental ingestion, give emetic or stomach washout. Treatment should be symptomatic and in severe oral overdose ensure the airway is clear and give fluids. Check and correct electrolyte balance, monitor blood gases and liver function. Blood count should be monitored for at least 5 days.

Pharmaco-therapeutic group: D06B B Antivirals

Podophyllotoxin is a metaphase inhibitor in dividing cells binding to at least one binding site on tubulin. Binding prevents tubulin polymerisation required for microtubule assembly. At higher concentrations, podophyllotoxin also inhibits nucleoside transport through the cell membrane.

The chemotherapeutic action of podophyllotoxin is assumed to be due to inhibition of growth and the ability to invade the tissue of the viral infected cells.

Systemic absorption of podophyllotoxin after topical application with a higher strength, 0.3% is low. Thus no study was performed on the present strength, 0.15%. The C_max (1.0 – 4.7 ng/ml) and T_max (0.5 – 36 hrs) are comparable for the 0.3% cream and 0.5% solution in both males and females.

No relevant findings

Purified Water;

Methyl parahydroxybenzoate E218;

Propyl parahydroxybenzoate E216;

Sorbic acid;

Phosphoric acid;

Stearyl alcohol;

Cetyl alcohol;

Isopropyl myristate;

Paraffin, liquid;

Fractionated coconut oil;

Butylhydroxyanisole (BHA) E320;

Macrogol –7 stearyl ether;

Macrogol – 10 stearyl ether.

None known

3 years

This medicinal product does not require any special storage precautions.

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.

No special requirements

Stiefel Laboratories (UK) Ltd.

Eurasia Headquarters

Concorde Road,

Maidenhead

SL6 4BY

PL 00174/0210

26 April 1999/18 January 2000/18 January 2005

February 2005/June 2009