CONDYLINE 0,5% Roztwór do stosowania miejscowego

Treść ulotki

1. Condyline 0,5 % cutaneous solution
   1. What is Condyline 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

Condyline 0,5 % cutaneous solution

Podophyllotoxin

Read this leaflet carefully before using this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If any side effects occur, 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 you use 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 it is used for

Condyline contains the active ingredient podophyllotoxin, an extract that comes from a plant and belongs to a group of medicines called “antivirals”.
Condyline is a medicine for local use, indicated for the treatment of some types of warts that form on the external skin in the genital area (external acute condylomas).
Contact your doctor if you do not feel better or if you feel worse after the prescribed treatment period.

2. What you need to know before using Condyline

Do not use Condyline

• if you are allergic to podophyllotoxin or 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 healthy mucous membranes or skin near or at the base of the warts, as this may cause local irritation and/or damage to healthy mucous membranes or skin. To avoid accidental contact of healthy tissue with the Condyline solution before starting treatment, you can protect the healthy area by applying a neutral ointment or cream, based on petroleum jelly or zinc oxide.
• Avoid contact of this medicine with the eyes, as it may cause serious irritation. If this happens accidentally, rinse your eyes immediately and thoroughly with water and consult a doctor.
• Avoid applying this medicine to large areas as this may cause undesirable effects involving various organs of the body.
• If you are a woman and using this medicine is difficult, as the lesion is inaccessible for self-medication, consult your doctor for the 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
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
In particular, tell your doctor if you are taking other medicines containing podophyllin, as in
this case you cannot 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 with
breast milk.

Driving and operating machinery
This medicine does not impair the ability to drive and operate 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 following the instructions of your doctor or pharmacist exactly. If you have
any doubts, consult your doctor or pharmacist.

Adults
The recommended dose is one application twice a day, morning and evening.

Duration of treatment
Apply this medicine, morning and evening, for 3 consecutive days.
The treatment schedule may be repeated weekly for a maximum of 5 consecutive weeks,
leaving 4 days of interval without treatment between weeks.
The 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 on the cap and unscrew simultaneously in the direction indicated by the arrow (as shown in the figure).

• Apply the solution to the area of skin to be treated using one of the applicatorscontained in the packageavoiding contact with healthy skin (see section “Warnings and precautions”).
• After application, allow it to air dry completely to prevent the solution from coming into contact with healthy areas, especially when the warts are located on the prepuce (skin fold covering the end of the penis in men).
• After application, discard the used applicator and wash your hands thoroughly.
• After use, close the cap. The bottle is child-resistant if, when unscrewing the cap without pressing, you hear a click.

If you use more Condyline than you should
No adverse effects have been reported due to the use of an excessive dose of Condyline.
However, if you accidentally use more Condyline than you should and adverse effects occur,
contact your doctor or the nearest hospital immediately. The doctor will adopt the
appropriate supportive therapy.

If you forget to use Condyline
Do not use a double dose to make up for a missed dose.

If you stop using Condyline
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Local side effects usually appear on the second or third day of treatment
when the wart begins to die. Generally, side effects are mild and
are well tolerated.
The frequency of the following side effects is not known.

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 balanoposthitis (infection of the penis). This effect occurs in the case of large warts in the prepuce cavity

In case of incorrect application of the product, the following may also occur:

• stomach and intestinal disorders
• leukopenia (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 (disease of the peripheral nervous system)
• sensory disturbances generally mild (mild mental confusion), these effects may progress and become complicated by more serious conditions affecting the central nervous system.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform
your doctor. You can also report side effects directly through the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects you can help to 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 at a temperature below 25  C.
Do not use this medicine after the expiry date which is stated on the pack after SCAD. The expiry
date refers to the last day of that month.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

• the active ingredient is: podophyllotoxin (1 ml of solution contains 5 mg of podophyllotoxin
• the other ingredients are: lactic acid, sodium lactate, ethanol 96%, water.

Description of the appearance of Condyline and contents of the pack
Condyline is presented as a solution for topical use, packaged in a bottle containing 3.5 ml of solution.
The box contains two packs of 15 applicators necessary for therapy.

Marketing Authorisation Holder
Karo Pharma AB
Box 16184
103 24 Stockholm
Sweden

Manufacturer
Delpharm Bladel B.V. - Industrieweg 1 - 5531AD Bladel (Netherlands)