Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Takeda UK Limited, 1 Kingdom Street, London, W2 6BD, United Kingdom
For the topical treatment of condylomata acuminata (warts) affecting the penis or the female external genitalia.
For topical administration.
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.
Not recommended in children under 12 years of age.
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.
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.
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