CONDYLINE Cutaneous solution Ref.[27527] Active ingredients: Podophyllotoxin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Takeda UK Limited, 1 Kingdom Street, London, W2 6BD, United Kingdom

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.

6.2. Incompatibilities

None stated.

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