CONDYLINE 5 mg /Ml Solution

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. CONDYLINE, 5 mg/ml, solution for the skin
   1. Read the package leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of Contents of the Package Leaflet
3. What is Condyline and what is it used for
4. Important information before using Condyline
   1. When not to use Condyline:
   2. Warnings and precautions
   3. Children
   4. Condyline and other medicines
   5. Pregnancy and breastfeeding
   6. Driving and using machines
   7. Condyline contains alcohol (ethanol)
5. How to use Condyline
   1. Using more than the recommended dose of Condyline
6. Possible side effects
   1. Reporting side effects
7. How to store Condyline
8. Contents of the pack and other information
   1. What Condyline contains
   2. What Condyline looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder
   5. Manufacturer

Package Leaflet: Information for the Patient

CONDYLINE, 5 mg/ml, solution for the skin

Podophyllotoxin

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package 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 pack 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, which causes necrosis of condylomata acuminata. Condyline acts faster and more effectively than podophyllin because it contains purified and standardized podophyllotoxin. Condyline is indicated for the treatment of condylomata acuminata.

2. Important information before using Condyline

When not to use Condyline:

• during pregnancy and breastfeeding;
• in children;
• concomitantly with 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 treatment with Condyline, discuss it with your doctor. To avoid accidental spread of Condyline to unaffected skin, after application to the surface of the condyloma, it should be left to dry completely. This is especially important for condylomata located under the foreskin. Avoid contact of Condyline with the eyes, as it can cause severe irritation. In case of contact with the eyes, they should be rinsed carefully with a large amount of water. Condyline should not be applied to large areas, as this may cause systemic toxic reactions. The medicine should only be used on condylomata acuminata. Contact with healthy skin and mucous membranes should be avoided. Accidental contact of Condyline with the mucous membrane or skin surrounding the condyloma 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. It should not be used 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

Tell your doctor about all the medicines you are taking, or have recently taken, and any you plan to take.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, 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 application (especially during treatment of condylomata located on a large surface area), 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 excluded 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 affect this ability.

Condyline contains alcohol (ethanol)

This medicine contains 726 mg of alcohol (ethanol) in each 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 are unsure, consult your doctor. The medicine is for topical use only. Condyline is applied to the condylomata acuminata using the enclosed applicator and then left to dry completely to avoid accidental spread to unaffected skin or mucous membranes. This is especially important for condylomata 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 every week for a period not exceeding 5 consecutive weeks.

Using more than the recommended dose of Condyline

After topical application of higher doses of Condyline than recommended or application to 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 disorders of the central nervous system, 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. 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 1000 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 1000 patients; very rare - side effects occurring in less than 1 in 10,000 patients. Very common: pain, erythema, 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 condyloma begins. Uncommon: edema, inflammation of the glans penis and foreskin in some patients with extensive condylomata 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 not listed in this leaflet, please inform 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Condyline

Keep the medicine out of the sight and reach of children. Store in a temperature below 25°C. Do not use this medicine after the expiry date stated on the carton and bottle after {EXP}. The expiry date refers to the last day of the month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Condyline contains

• The active substance is podophyllotoxin. 1 ml of solution for the skin contains 5 mg of podophyllotoxin.
• The other ingredients are: lactic acid, sodium lactate, ethanol 96%, purified water.

What Condyline looks like and contents of the pack

A bottle containing 3.5 ml of solution and 2 sets of 15 applicators, in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder

Karo Pharma AB, Box 16184, 103 24 Stockholm, Sweden, [email protected]

Manufacturer

Delpharm Bladel B.V., Industrieweg 1, Bladel 5531 AD, Netherlands, Date of last revision of the package leaflet: