Condyline

PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep the leaflet; information on the outer packaging in a foreign language!
Condyline
5 mg/ml, solution for cutaneous use
Podophyllotoxinum
Please read carefully all the information in this leaflet before using the medicine, as it
contains important information for the patient.

• Keep this leaflet for future reference.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. 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 adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Condyline is and what it is 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 Condyline is and what it is used for

Condyline contains the active substance podophyllotoxin – one of the components of podophyllin – which causes necrosis of genital warts. Condyline acts faster and more effectively than podophyllin because 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;
• concurrently with other medications containing podophyllin, due to toxic effects;
• if the patient is allergic to podofilotoxin 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, allow the solution to dry completely after application to the warts.
This is especially important for warts located under the foreskin.
Avoid contact of Condyline with the eyes, as it may cause severe irritation. In case of contact with the eyes, rinse thoroughly with plenty of water.
Avoid using the medicine on extensive areas, as this may lead to systemic toxic reactions.
The medicine should be applied only to external anogenital warts.
Avoid contact of the medicine with healthy skin and mucous membranes.
Accidental contact of Condyline with mucous membranes or surrounding skin may cause local irritation and/or ulceration. This can be prevented by applying a protective layer of cream, vaseline, or zinc ointment to the surrounding skin before applying the medicine.
The product is highly flammable. Do not use near open flames, lit cigarettes, or certain devices (e.g. hair dryers).
Children
Condyline must not be used in children.
Condyline and other medicines
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, suspect you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist.
Condyline must not be used during pregnancy and breastfeeding.
Due to the cytostatic effect of podofilotoxin and systemic absorption of the active substance following topical application (especially during treatment of warts covering large areas), the medicine may harm the unborn child.
It is not known whether podophyllin and/or its metabolites pass into human milk. Due to the cytostatic activity of podofilotoxin, effects on the infant cannot be excluded.
Driving and operating machinery
There is no data available regarding the effect of Condyline on the ability to drive or operate machinery. However, it does not appear that the medicine may impair such ability.
Condyline contains alcohol (ethanol)
This medicine contains 726 mg of alcohol (ethanol) per ml of solution. Condyline may cause a burning sensation on damaged skin.

3. How to use Condyline

This medicine should always be used exactly as recommended by the doctor. In case of doubt, consult the doctor.
This medicine is intended for topical use only.
Condyline should be applied to genital warts using the provided applicator and then left to dry completely to avoid accidental spread of the medicine to unaffected skin or mucous membranes. This is especially important for warts located under the foreskin.
Condyline is usually applied twice daily for 3 consecutive days.
If recommended by the doctor, treatment may be repeated weekly for up to 5 consecutive weeks.
Use of a higher than recommended dose of Condyline
After applying larger amounts of Condyline than recommended or applying it to extensive skin areas, severe local reactions and systemic symptoms of poisoning may occur.
In case of accidental ingestion, severe symptoms of systemic poisoning may occur, especially nausea, vomiting, diarrhoea, tachycardia, hypotension, increased respiration (including respiratory failure), and central nervous system disorders such as dizziness, mental confusion, coma, and peripheral neuropathy.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The possible adverse reactions of this medicine are listed below in the following frequency categories:
Very common – affects more than 1 in 10 patients;
Common – affects more than 1 in 100 patients, but less than 1 in 10 patients;
Uncommon – affects more than 1 in 1,000 patients, but less than 1 in 100 patients;
Rare – affects more than 1 in 10,000 patients, but less than 1 in 1,000 patients;
Very rare – affects less than 1 in 10,000 patients.

Very common: pain, erythema, superficial ulceration
These symptoms are mainly related to the action of the medicine and usually occur on the second or third day of treatment, when 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 initiate anti-inflammatory treatment for a few days.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Condyline

Keep this medicine out of the sight and reach of children.
Store below 25°C. Keep in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the container.
The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the packaging and other information

What Condyline contains

• The active substance is podofilox. Each 1 ml of cutaneous solution contains 5 mg of podofilox.
• The other components are: ( S )-lactic acid, sodium ( S )-lactate solution, ethanol 96%.

What Condyline looks like and contents of the pack
A brown glass bottle (type III), with a PP cap with child-resistant closure, together with applicators, in a cardboard box.
1 bottle of 3.5 ml

For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing authorisation 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

Relabelled in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Marketing authorisation number in Bulgaria, the country of export: 9600016
Parallel import licence number: 177/20