Condyline 0.5% w/v Cutaneous Solution

Condyline contains 0.5% podophyllotoxin in vials of 3.5 ml.

For a full list of excipients, see section 6.1.

Cutaneous Solution.

Each pack of Condyline consists of a 3.5ml amber glass vial containing 0.5% podophyllotoxin in a clear, colourless alcoholic solution. Each pack also includes a suitable quantity of special applicators.

For the topical treatment of condylomata acuminata, (warts) affecting the penis or the female external genitalia.

For topical administration.

Adults and the elderly

Apply twice daily for three days directly to the warts. Allow to dry after treatment.

Use the applicator provided, applying not more than 50 applicators-fill for each treatment.

This three day treatment may be repeated, if necessary, at weekly intervals for a total of five weeks of treatment.

Children

Not recommended.

Hypersensitivity to podophyllotoxin.

Avoid contact with healthy skin. Lesions in the female and lesions greater than 4cm² in the male should be treated under direct medical supervision. Do not use on inflamed or bleeding lesions or on open wounds following surgical procedures.

None known

Condyline is not recommended for use during pregnancy or during breast feeding.

Condyline does not interfere with the ability to drive or use machines.

Local irritation, usually mild, may occur.

In topical overdosage, wash well with soap and water; if the eyes are involved bathe thoroughly with water or if available, with an appropriate eye-cleaning solution. If accidentally ingested, give stomach washout and monitor electrolyte balance, blood gases, liver function and blood picture.

Podophyllotoxin is an anti-mitotic agent, with a topical action against warts.

The product is applied locally directly to the warts, and activity is a result of local perfusion of the affected tissue.

No relevant studies have been performed.

Lactic acid,

Sodium lactate 60% solution,

Ethanol 96%.

None stated

The shelf life of the unopened vial is 2 years from the date of manufacture. Once opened, the product has a shelf life of 6 weeks.

Do not store above 25°C.

Each pack of Condyline consists of a 3.5ml amber glass vial fitted with a child resistant closure. The pack also includes a suitable quantity of special applicators.

Condyline is flammable and should be kept away from naked flames. A patient information leaflet is provided with the product giving details on the use and handling of the product.

Nycomed Danmark A/S

Langebjerg 1

PO Box 88

DK-4000 Roskilde

Denmark

PL 15475/0007

23 January 2009

7^th November 2010