Condyline
Poland
Table of Contents
Patient Information Leaflet
Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.
Condyline
5 mg/ml, cutaneous solution
Podophyllotoxinum
Please read the entire leaflet carefully before using this medicine,
as it contains important information for the patient.
Keep this leaflet for future reference.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not share it with others.
The medicine may harm another person, even if their symptoms are the same.
If you experience any adverse reactions, including those not listed in this leaflet,
inform your doctor, pharmacist, or nurse. See section 4.
Table of Contents
- What Condyline is and what it is used for
- Important information before using Condyline
- How to use Condyline
- Possible side effects
- How to store Condyline
- 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 podophyllotoxin or any of the other ingredients of this
medicinal product (listed in section 6).
Warnings and precautions
Before starting treatment with Condyline, consult your doctor.
To avoid accidental spreading of Condyline onto unaffected skin, allow the solution to dry completely after application to the warts. This is particularly important for warts located under the foreskin.
Avoid contact of Condyline with the eyes, as it may cause severe irritation. If contact occurs, rinse the eyes thoroughly with plenty of water.
Avoid applying the medicinal product over large areas, as this may lead to systemic toxic reactions.
The medicinal product should be applied only to external anogenital warts.
Avoid contact of the medicinal product 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 healthy skin before treatment.
The medicinal product is highly flammable. Do not use near open flames, lit cigarettes, or certain electrical devices (e.g. hair dryers).
Children
Condyline must not be used in children.
Condyline and other medicinal products
Inform your doctor about any other medicinal products you are currently using, have recently used, or plan to use.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist.
Condyline must not be used during pregnancy and breastfeeding.
Due to the cytostatic action of podophyllotoxin and systemic absorption of the active substance following topical application (especially during treatment of warts covering large areas), the medicinal product may harm the unborn child.
It is unknown whether podophyllin and/or its metabolites pass into breast milk. Due to the cytostatic effect of podophyllotoxin, a harmful effect on the infant cannot be excluded.
Driving and operating machinery
There are no data on the effect of Condyline on the ability to drive or operate machinery. However, it seems unlikely that the medicinal product would impair such ability.
Condyline contains alcohol (ethanol)
This medicinal product 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 your doctor has instructed. If in doubt, consult your doctor.
This medicine is for topical use only. Condyline should be applied to genital warts using the supplied applicator, 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 your doctor recommends it, treatment may be repeated weekly for no longer than 5 consecutive weeks.
Use of a higher than recommended dose of Condyline
If larger than recommended amounts of Condyline are applied locally or if applied to extensive skin areas, severe local reactions and systemic symptoms of poisoning may occur.
In case of accidental ingestion, severe systemic poisoning symptoms may occur, especially nausea, vomiting, diarrhoea, tachycardia, hypotension, increased respiration (including respiratory failure), 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 order:
very common – reactions occurring in more than 1 out of 10 patients;
common – reactions occurring in more than 1 out of 100 patients, but less than 1 out of 10 patients;
uncommon – reactions occurring in more than 1 out of 1,000 patients, but less than 1 out of 100 patients;
rare – reactions occurring in more than 1 out of 10,000 patients, but less than 1 out of 1,000 patients;
very rare – reactions occurring in less than 1 out of 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, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, telephone: +48 22 4921301, fax: +48 22 4921309, website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions allows the collection of additional information on the safety of the medicine.
5. How to store Condyline
Keep the medicine out of sight and reach of children.
Store below 25°C in the original packaging.
Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the month indicated.
Medicines must 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 topical solution contains 5 mg of podophyllotoxin.
The other components are: lactic acid, sodium lactate, 96% ethanol, purified water.
What Condyline looks like and contents of the pack
A brown glass bottle containing 3.5 ml of solution with a child-resistant closure, supplied with 15 applicators, in a cardboard box.
For further information, please contact the responsible party or the parallel importer.
Responsible party in Romania, country of export:
KARO PHARMA AB
Box 16184, 103 24 Stockholm, Sweden
Manufacturer:
DELPHARM BLADEL B.V.
Industrieweg 1, 5531 AD Bladel, The Netherlands
Parallel importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź, Poland
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź, Poland
Authorisation number in Romania, country of export: 7223/2006/01
Parallel import authorisation number: 100/26