Condyline 0.5% W/V Cutaneous Solution
SUMMARY OF PRODUCT CHARACTERISTICS
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.
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. Interactions with other Medicaments and other forms of Interaction
None known
4.6
Fertility, 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.
4.9 Overdose Symptoms
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.
Treatment
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 properties Absorption
After topical application, podophyllotoxin is absorbed through the skin or mucous membranes. The extent of absorption depends on the concentration used.
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.
Distribution
Owing to its high lipid solubility, it is distributed through the body including the CNS.
Metabolism
No data are available on the metabolism of podophyllotoxin.
Elimination
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.
6.6. Instruction for Use/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
Takeda Pharma A/S Dybendal Alle 10 2630 Taastrup Denmark
8 MARKETING AUTHORISATION NUMBER(S)
PL 15475/0007
9 DATE OF RENEWAL OF THE AUTHORISATION
23 January 2009
10 DATE OF REVISION OF THE TEXT
11/06/2015