Condyline

Package leaflet: Information for the user

Condyline 0.5% cutaneous solution

Podophyllotoxin
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Condyline is and what it is used for
2. What you need to know 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, an extract derived from a plant, belonging to a group of medicines called "antivirals".
Condyline is a topical medicine indicated for the treatment of certain types of warts that develop on the external skin in the genital area (external genital warts).
If you do not feel better or feel worse after the expected treatment period, consult your doctor.

2. What you need to know before using Condyline

Do not use Condyline

• if you are allergic to podophyllotoxin or to any of the other ingredients of this medicine (listed in section 6)
• in children
• if you are pregnant (see section “Pregnancy and breastfeeding”)
• if you are breastfeeding (see section “Pregnancy and breastfeeding”)
• if you are taking other medicines containing podophyllin.

Warnings and precautions
Talk to your doctor or pharmacist before using Condyline.

• Avoid contact of the Condyline solution with mucous membranes or healthy skin near or at the base of the warts, as this may cause local irritation and/or damage to healthy mucosa or skin. To prevent accidental contact of healthy areas with the Condyline solution, you may protect the surrounding healthy skin before starting treatment by applying a neutral ointment or cream based on vaseline or zinc oxide.
• Avoid contact of this medicine with the eyes, as it may cause severe irritation. If accidental contact occurs, rinse the eyes immediately and thoroughly with water and consult your doctor.
• Avoid applying this medicine to large areas of skin, as this may cause unwanted effects affecting various organs of the body.
• If you are a woman and application of this medicine is difficult because the lesion is inaccessible for self-treatment, consult your doctor for proper application of Condyline.
• If the effect of this medicine is not evident after the prescribed treatment period, your doctor will consider alternative therapies.

Children
Condyline must not be used in children.
Other medicines and Condyline
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking other medicines containing podophyllin, as in this case you must not use this medicine (see section “Do not use Condyline”).
Pregnancy and breastfeeding
Do not use Condyline if you are pregnant, suspect you may be pregnant, or are breastfeeding.
Driving and using machines
This medicine does not affect the ability to drive or use machinery.
This medicine contains 732 mg of alcohol (ethanol) per ml. It may cause a burning sensation on damaged skin.

3. How to use Condyline

Use this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Adults
The recommended dose is one application twice daily, in the morning and evening.
Duration of treatment
Apply this medicine in the morning and evening for 3 consecutive days.
This treatment cycle may be repeated weekly for up to a maximum of 5 consecutive weeks,
with a 4-day treatment-free interval between each week.
This product should be used for short periods and under medical supervision.
Instructions for correct use

• The bottle is equipped with a child-resistant safety closure. To open the bottle, press down on the cap and simultaneously unscrew it in the direction indicated by the arrow (as shown in the figure).

• Apply the solution to the affected skin area using one of the applicators provided in the package, avoiding contact with healthy skin (see section “Warnings and precautions”).
• After application, allow the solution to dry thoroughly in the air to prevent it from spreading to healthy areas, especially when warts are located on the foreskin (the fold of skin covering the tip of the penis in men).
• After application, discard the used applicator and wash your hands thoroughly.
• After use, close the cap. The bottle has a child-resistant closure if, when unscrewing the cap without pressing, you hear a clicking sound.

If you use more Condyline than you should
No adverse effects due to an overdose of Condyline have been reported.
However, if you accidentally use more Condyline than you should and experience any adverse effects, contact your doctor or the nearest hospital immediately. The doctor will provide appropriate supportive treatment.
If you forget to use Condyline
Do not use a double dose to make up for the missed dose.
If you stop using Condyline
If you have any questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody experiences them.
Local side effects mostly occur on the second or third day of treatment, when the death of the wart begins.
Generally, side effects are mild in intensity and well tolerated.
The frequency of the following side effects is unknown.

Side effects affecting the skin and mucous membranes

• Erythema (skin irritation) with mild pain and/or superficial skin lesions in the treated area. In this case, application of Condyline may be painful
• Edema (swelling) and balanopostitis (infection of the tip of the penis). This effect occurs in cases of large warts located within the foreskin cavity

If the product is incorrectly applied, the following may also occur:

• Gastrointestinal disturbances
• Leucopenia (reduction in the number of white blood cells in the blood)
• Thrombocytopenia (reduction in the number of platelets in the blood)
• Alterations in liver function
• Alterations in kidney function
• Peripheral neuropathies (diseases of the peripheral nervous system)
• Sensory disturbances, generally mild (slight mental confusion); these effects may progress and lead to more serious conditions affecting the central nervous system

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor.
You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Condyline

Keep this medicine out of the sight and reach of children.
Store below 25  C.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

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

Description of the appearance of Condyline and contents of the pack
Condyline is a solution for local use, supplied in a 3.5 ml bottle.
The package contains two packs of 15 applicators required for the treatment.
Marketing Authorization Holder
Karo Pharma AB
Box 16184
103 24 Stockholm
Sweden
Manufacturer
Delpharm Bladel B.V. - Industrieweg 1 - 5531AD Bladel (The Netherlands)