Condyline

1. Name Of The Medicinal Product

Condyline 0.5% w/v Cutaneous Solution

2. Qualitative And Quantitative Composition

Condyline contains 0.5% podophyllotoxin in vials of 3.5 ml.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

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.

4. Clinical Particulars

4.1 Therapeutic Indications

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

4.2 Posology And Method Of Administration

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.

4.3 Contraindications

Hypersensitivity to podophyllotoxin.

4.4 Special Warnings And Precautions For Use

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.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known

4.6 Pregnancy And Lactation

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

4.7 Effects On Ability To Drive And Use Machines

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

4.8 Undesirable Effects

Local irritation, usually mild, may occur.

4.9 Overdose

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.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

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

5.2 Pharmacokinetic Properties

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

5.3 Preclinical Safety Data

No relevant studies have been performed.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Lactic acid,

Sodium lactate 60% solution,

Ethanol 96%.

6.2 Incompatibilities

None stated

6.3 Shelf Life

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.

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

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.

6.6 Special Precautions For Disposal And Other Handling

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.

7. Marketing Authorisation Holder

Nycomed Danmark A/S

Langebjerg 1

PO Box 88

DK-4000 Roskilde

Denmark

8. Marketing Authorisation Number(S)

PL 15475/0007

9. Date Of First Authorisation/Renewal Of The Authorisation

23 January 2009

10. Date Of Revision Of The Text

7^th November 2010