Condyline^® (Solution) Instructions for Use

Marketing Authorization Holder

Leo Pharma, A/S (Denmark)

Manufactured By

Astellas Pharma Europe B.V. (Netherlands)

Or

Famar Nederland, B.V. (Netherlands)

ATC Code

D06BB04 (Podophyllotoxin)

Active Substance

Podophyllotoxin (BAN)

Dosage Form

Condyline®

Solution for external use 0.5%: bottle 3.5 ml in set with applicators

Dosage Form, Packaging, and Composition

Solution for external use 0.5% colorless, transparent.

Excipients: lactic acid – 51.67 mg, sodium lactate – 7.79 mg, ethanol – 735 mg, purified water – 30.6 mg.

3.5 ml – dark glass bottles (1) in a set with applicators (30 pcs.) – cardboard packs.

Clinical-Pharmacological Group

Drug with cauterizing and mummifying action

Pharmacotherapeutic Group

Local necrotizing agent

Pharmacological Action

An agent with a cauterizing and mummifying action. It is a component of podophyllin, obtained from an extract of the roots of the Podophyllum plant.

It has a cytostatic effect and reduces the severity of inflammatory reactions. When applied topically, it causes necrosis of condylomata acuminata.

Indications

• Apply topically for the treatment of condylomata acuminata (anogenital warts).

Use only on the specific lesions for which it has been prescribed by a healthcare professional.

ICD codes

Dosage Regimen

Apply the solution twice daily for 3 consecutive days, followed by a 4-day treatment-free interval.

This one-week cycle may be repeated until there are no visible warts, for a maximum of 5 weeks.

Use the applicator provided to apply the solution precisely to each wart, avoiding contact with surrounding healthy skin and mucous membranes.

Adverse Reactions

Common adverse reactions include local skin reactions such as redness, soreness, burning, itching, and ulceration at the application site.

These reactions are typically most pronounced during the initial days of treatment. In the presence of large preputial condylomas, edema and balanoposthitis may occur. Allergic reactions are possible.

Drug Interactions

Do not use concurrently with other podophyllin-containing preparations due to the risk of additive toxic effects.

Avoid concomitant application of other topical medications, including creams or ointments, to the same treatment area unless specifically directed by a physician.

Contraindications

• Do not use in patients with known hypersensitivity to podophyllotoxin, podophyllin, or any of the excipients.

• Contraindicated during pregnancy and lactation (breastfeeding).

• Contraindicated for use in children and adolescents.

• Avoid simultaneous treatment with other drugs containing podophyllin resin.

Overdose

Systemic absorption following topical overdose may lead to nausea, vomiting, diarrhea, abdominal pain, peripheral neuropathy, acute confusional states, renal impairment, and bone marrow suppression including leukopenia and thrombocytopenia.

In case of accidental ingestion, seek immediate medical attention. If excessive topical application occurs, thoroughly wash the affected area with soap and water and monitor for systemic symptoms.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and during lactation (breastfeeding).

Pediatric Use

Contraindicated for use in childhood.

Special Precautions

It is not intended for the treatment of other warts or birthmarks.

In case of contact of the solution with the eye mucosa, it is necessary to immediately rinse them with water.

When using podophyllotoxin, avoid getting it on healthy skin and mucous membranes surrounding the condyloma. Particular caution should be exercised when condylomas are located in the foreskin area.

Men should use condoms until complete recovery. Examination and, if necessary, treatment of sexual partners is required.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.