Condyline
Poland
Table of Contents
Package leaflet: Information for the patient
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 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 someone else, 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
medication (listed in section 6).
Warnings and precautions
Before starting treatment with Condyline, consult your doctor.
To avoid accidental spread of Condyline to 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 with the eyes, as Condyline causes severe irritation. If contact occurs, rinse the eyes thoroughly with plenty of water.
Avoid applying the medication to large areas, as this may lead to systemic toxic reactions.
Condyline should be applied only to external anogenital warts.
Avoid contact of the medication 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 medication.
The medication is flammable. Do not use Condyline near open flames, lit cigarettes, or certain devices (e.g. hair dryers).
Children
Condyline must not be used in children.
Condyline and other medicines
Inform your doctor about all medications currently used or recently used, as well as any medications you plan to use.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist.
Condyline must not be used during pregnancy and breastfeeding.
Due to the cytostatic effect of podophyllotoxin and systemic absorption of the active substance following topical application (especially during treatment of warts covering a large surface area), the medication may harm the fetus.
It is unknown whether podophyllin and/or its metabolites pass into human milk. Due to the cytostatic action of podophyllotoxin, a harmful effect on the infant cannot be excluded.
Driving and operating machinery
There is no data regarding the effect of Condyline on the ability to drive or operate machinery. However, it does not appear that Condyline may impair such ability.
Condyline contains alcohol (ethanol 96%)
Condyline contains 765.74 mg of alcohol (96% 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 as directed by the physician. If in doubt, consult your doctor.
This medicine is intended for topical use only. Condyline should be applied to genital warts using the supplied 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 directed by the physician, treatment may be repeated weekly for up to 5 consecutive weeks.
Use of a higher than recommended dose of Condyline
Following application of larger than recommended doses or use on extensive skin areas, severe local reactions and systemic signs of poisoning may occur.
In case of accidental ingestion, severe systemic poisoning symptoms may occur, especially nausea, vomiting, diarrhoea, tachycardia, hypotension, respiratory stimulation (including respiratory failure), central nervous system disturbances such as dizziness, lethargy, 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 in 10 patients;
Common – reactions occurring in more than 1 in 100 patients, but less frequently than in 1 in 10 patients;
Uncommon – reactions occurring in more than 1 in 1,000 patients, but less frequently than in 1 in 100 patients;
Rare – reactions occurring in more than 1 in 10,000 patients, but less frequently than in 1 in 1,000 patients;
Very rare – reactions occurring in 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 symptoms occur, including any adverse symptoms not listed in this leaflet, inform your doctor, pharmacist, or nurse. 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, Tel.: +48 22 4921301, Fax: +48 22 4921309, website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safe use of the medicine.
5. How to store Condyline
Keep the medicine out of the sight and reach of children.
Store below 25°C.
Keep in the original packaging to protect from light.
The shelf life after first opening the immediate packaging is 6 weeks.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.
6. Contents of the pack and other information
What Condyline contains
The active substance is podophyllotoxin. 1 ml of cutaneous solution contains 5 mg of
podophyllotoxin.
The other ingredients are: ( S )-lactic acid, sodium ( S )-lactate solution, ethanol 96%.
What Condyline looks like and contents of the pack
A clear, colourless, transparent solution with the smell of ethanol.
An amber glass bottle (type III) containing 3.5 ml of cutaneous solution, with a PP cap fitted with child-resistant closure, supplied with applicators, in a cardboard carton.
For further 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:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing authorisation number in Bulgaria, the country of export: 9600016
Parallel import licence number: 794/15