Condiline

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!

Condyline

5 mg/ml, solution for the skin

Podophyllotoxin

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Condyline and what is it used for
• 2. Important information before using Condyline
• 3. How to use Condyline
• 4. Possible side effects
• 5. How to store Condyline
• 6. Contents of the packaging and other information

1. What is Condyline and what is it used for

Condyline contains the active substance podophyllotoxin - one of the components of podophyllin - causing necrosis of genital warts. Condyline works faster and more effectively than podophyllin, as it contains purified and standardized podophyllotoxin. Condyline is indicated for the treatment of genital warts.

2. Important information before using Condyline

When not to use Condyline:

• during pregnancy and breastfeeding;
• in children;
• at the same time as other medicines containing podophyllin, due to toxic effects;
• if the patient is allergic to podophyllotoxin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting to use Condyline, you should discuss it with your doctor. To avoid accidental spreading of Condyline to unchanged skin, after applying it to the surface of the warts, you should let it dry completely. This is especially true for warts located under the foreskin. You should avoid contact between Condyline and the eyes, as it can cause severe irritation. If the medicine comes into contact with the eyes, they should be rinsed carefully with a large amount of water. You should avoid using the medicine on large areas, as this may cause systemic toxic reactions. The medicine should only be used on genital warts. You should avoid contact between the medicine and healthy skin and mucous membranes. Accidental contact between Condyline and the mucous membrane or skin surrounding the warts may cause local irritation and/or ulceration. This can be prevented by applying a protective layer of cream, petroleum jelly, or zinc ointment to the skin before using the medicine. The medicine is flammable. You should not use the medicine near an open flame, a lit cigarette, or certain devices (e.g., hair dryers).

Children

Condyline should not be used in children.

Condyline and other medicines

You should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist. Condyline should not be used during pregnancy and breastfeeding. Due to the cytostatic effect of podophyllotoxin and systemic absorption of the active substance after topical use (especially during the treatment of warts located on a large surface), the medicine may harm the fetus. It is not known whether podophyllin and/or its metabolites pass into breast milk. Due to the cytostatic effect of podophyllotoxin, it cannot be ruled out that the medicine may affect the infant.

Driving and using machines

There are no data on the effect of Condyline on the ability to drive and use machines. However, it does not seem that the medicine could have any impairing effect on this ability.

Condyline contains alcohol (ethanol)

This medicine contains 726 mg of alcohol (ethanol) per ml of solution. Condyline may cause burning of damaged skin.

3. How to use Condyline

This medicine should always be used as directed by your doctor. If you have any doubts, you should consult your doctor. The medicine is for topical use only. Condyline is applied to the genital warts using the included applicator and then left to dry completely to avoid accidental spreading of the medicine to unchanged skin or mucous membranes. This is especially true for warts located under the foreskin. Condyline is usually applied twice a day for 3 consecutive days. If your doctor recommends it, the treatment can be repeated once a week, for a period not exceeding 5 consecutive weeks.

Using a higher dose of Condyline than recommended

After topical use of higher doses of the medicine than recommended or using it on large areas, severe local reactions and systemic symptoms of poisoning may occur. After accidental ingestion of the medicine, severe symptoms of general poisoning may occur, especially nausea, vomiting, diarrhea, tachycardia, hypotension, accelerated breathing (also respiratory failure), and central nervous system disorders, such as dizziness, confusion, coma, and peripheral neuropathy.

4. Possible side effects

Like all medicines, Condyline can cause side effects, although not everybody gets them. The possible side effects of Condyline are listed below in the following order: very common - side effects occurring in more than 1 in 10 patients; common - side effects occurring in more than 1 in 100 patients, but less than 1 in 10 patients; uncommon - side effects occurring in more than 1 in 1,000 patients, but less than 1 in 100 patients; rare - side effects occurring in more than 1 in 10,000 patients, but less than 1 in 1,000 patients; very rare - side effects occurring less than 1 in 10,000 patients. Very common: pain, redness, superficial ulceration. These symptoms are mainly related to the effect of the medicine and usually occur on the second or third day of treatment, when the necrosis of the wart begins. Uncommon: swelling, inflammation of the glans and foreskin in some patients with extensive warts located on the inner side of the foreskin. To alleviate local symptoms, the doctor may prescribe anti-inflammatory treatment for a few days.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. By reporting side effects, you can help provide more information on the safety of the medicine.

5. How to store Condyline

The medicine should be stored out of sight and reach of children. Store in a temperature below 25°C. Store in the original packaging to protect from light. Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month. Medicines should not be disposed of via wastewater or household waste containers. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Condyline contains

• The active substance of Condyline is podophyllotoxin. 1 ml of solution for the skin contains 5 mg of podophyllotoxin.
• The other ingredients are: (S)-lactic acid, sodium (S)-lactate, solvent, ethanol 96%.

What Condyline looks like and what the packaging contains

Bottle made of brown glass (type III), with a PP cap with a child-resistant closure, with applicators, in a cardboard box. 1 bottle of 3.5 ml. For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Bulgaria, the country of export:

Takeda Austria GmbH, St. Peter Strasse 25, A-4020 Linz, Austria

Manufacturer:

Takeda Austria GmbH, St. Peter Strasse 25, A-4020 Linz, Austria

Parallel importer:

Medezin Sp. z o.o., ul. Zbąszyńska 3, 91-342 Łódź

Repackaged by:

Medezin Sp. z o.o., ul. Zbąszyńska 3, 91-342 Łódź, Marketing authorization number in Bulgaria, the country of export: 9600016, Parallel import authorization number: 177/20

Date of approval of the leaflet: 20.05.2025

[Information about the trademark]