CONDYLINE 0.5% W/V CUTANEOUS SOLUTION - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Condyline5 mg/ml Cutaneous Solution

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Condyline contains 5 mg/ml 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 3.5 ml amber glass vial containing 5 mg/ml podophyllotoxin in a clear, colourless alcoholic solution.

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-full for each treatment.

This three day treatment may be repeated, if necessary, at weekly intervals for a total of five weeks of treatment. Only a small area or number of warts should be treated at any one time. Care must be taken to avoid application to healthy tissue.

Children

Not recommended in children under 12 years of age.

4.3 Contraindications

Condyline is contraindicated in patients with the following conditions/di­seases:

hypersensitivity to podophyllotoxin or to any of the other ingredients (see section 6.1);

inflamed or bleeding lesions;

open wounds following surgical procedures;

in combination with other podophyllin containing preparations;

pregnant or breast-feeding women;

Children under 12 years of age.

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.

The risk of toxicity is increased during simultaneous treatment with other podophyllin containing preparations since these also contain podophyllotoxin and should therefore be avoided.

The risk of systemic toxicity after topical application is increased by the treatment of large areas with excessive amounts for prolonged periods, by the treatment of friable, bleeding, or recently removed warts, and by inadvertent application to normal skin or mucous membranes.

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

Disorders of the reproductive system and breast

Balanoposthitis

Skin and subcutaneous tissue disorders

Local irritations (of the mucous membrane), usually mild, may include itching, burning, pain, erythema or epithelial ulceration

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9 OverdoseSymptoms

The risk of systemic toxicity after topical application is increased by the treatment of large areas with excessive amounts for prolonged periods, by the treatment of friable, bleeding, or recently removed warts, and by inadvertent application to normal skin or mucous membranes. Symptoms include nausea, vomiting, abdominal pain and diarrhoea; thrombocytopenia, leukopenia, hepatotoxicity or renal failure may occur. CNS-related adverse events are delayed in onset and prolonged in duration and include acute psychotic reactions, hallucinations, confusion, dizziness, stupor, ataxia, hypotonia, seizures and coma. Peripheral and autonomic neuropathies develop later and may result in paraesthesias, reduced reflexes, muscle weakness, tachycardia, apnoea, orthostatic hypotension, paralytic ileus and urinary retention.

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. It is applied locally to the lesion (e.g. wart) and causes destruction of the tissues locally. Podophyllotoxin and its derivatives have a special affinity for the microtubule protein of the mitotic spindle and thus arrest mitosis in metaphase leading to epithelial cell death. It is also caustic to normal skin if applied to it and can be absorbed into the systemic circulation with resultant toxic effects, in particular nausea, vomiting and thrombocytopenia.

5.2 Pharmacokinetic propertiesAbsorption

After topical application, podophyllotoxin is absorbed through the skin or mucous membranes. The extent of absorption depends on the concentration used.

2 Topical application of 0.1 ml of 5 mg/ml podophyllotoxin on an area of 4 cm2 resulted in maximum plasma concentrations of 5 ng/ml after 1–2 hours. After topical application of 0.1–0.15 ml on extreme large lesions the maximum plasma concentrations was 1–17 ng/ml.

Owing to its high lipid solubility, it is distributed through the body including the CNS.

No data are available on the metabolism of podophyllotoxin.

The serum half-life varies between 1 to 4.5 hours.

5.3 Preclinical safety data

Podophyllotoxin toxicity in animals is related to its cytotoxic activity. As a cytotoxic agent it has teratogenic potential and in reproductive toxicity studies has been associated with intrauterine deaths in mice and rats. Results from genotoxicity studies suggest podophyllotoxin has aneugenic activity consistent with its pharmacological action. No carcinogenic effects were reported in long term studies in rodents dosed via dietary administration up to 0.3 mg/kg/day.

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.