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CONDYLINE 0.5% W/V CUTANEOUS SOLUTION

Active substance(s): PODOPHYLLOTOXIN

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Patient Information Leaflet

Condyline 0.5% w/v Cutaneous Solution
Podophyllotoxin
Read all of this leaflet carefully before you start using this medicine.
-- Keep this leaflet, you may need to read it again.
-- If you have any further questions, ask your doctor or pharmacist.
-- This medicine has been prescribed for you. Do not pass it on to others. It
may harm them, even if their symptoms are the same as yours.
-- If any of the side effects get serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor.
-- In this leaflet, Condyline 0.5% w/v Cutaneous Solution will be called
Condyline.
In this leaflet:
1. What Condyline is and what it is used for
2. Before you use Condyline
3. How to use Condyline
4. Possible side effects
5. How to store Condyline
6. Further information
1. What Condyline is and what it is used for
Condyline is an alcoholic solution which contains the active ingredient
podophyllotoxin. This is a plant extract which is used to treat small clusters
of genital warts in adults known as condylomata acuminate that are found
on the penis or on the external female genital organs.
2. Before you use Condyline
Do not use Condyline
• If you are allergic to podophyllotoxin or any of the other ingredients in the
medicine (listed in section 6 ‘Further Information‘)
• If you are pregnant or breast feeding
• If you are a child under 12 years of age
• On healthy skin, skin that is bleeding or inflamed, or on open wounds
after an operation
• In combination with other products containing podophyllin.
Take special care with Condyline
• If you are female, this medicine should only be used under close medical
supervision.
• If you are male and have a lot of warts covering an area larger than
4x4 cm. You should only use this medicine under close medical
supervision.
• This medicine can cause systemic toxicity (effects on the whole body).
The risk of this is increased:
-- by treating mucus membranes or skin that is either normal, thin and
fragile, bleeding or had warts recently removed.
-- by treating large areas with excessive amounts for a long time.
-- if other products containing podophyllin are used at the same time as
these also contain podophyllotoxin.
Taking other medicines
Please tell your doctor if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding
Condyline is not recommended for use in women who are pregnant or
breast-feeding.
Driving and using machines
This medicine is not expected to interfere with your ability to drive or use
machines.
Important information about some of the ingredients of Condyline
This medicinal product contains alcohol (765.74 mg/ml).
3. How to use Condyline
Always use this medicine exactly as your doctor has told you.
Condyline is not recommended for use in children under 12 years of age.
Adults & elderly
First treatment:
1. Start the treatment in the morning.
2. Before applying Condyline, wash the affected parts with soap and water
and dry well.
3. Dip the end of the plastic applicator stick, which has a hole in it, into the
bottle, enough for the hole to be filled with solution.
4. Apply this solution onto a wart and let it dry by itself. Cover all of your
warts with solution in the same way, ensuring that you do not use more
than 50 “dips”. (Only a small area or small number of warts should be
treated at any one time).
5. Firmly replace the top on the bottle and wash your hands.
6. Steps 1-5 should be repeated 12 hours later on the same day, and then
twice a day (once in the morning and once in the evening) for the next
2 days so that you have 6 treatments in 3 days. No more treatments
should be used in the first week.

Extended treatment period:
If your warts have not disappeared or improved after the one week
treatment, your doctor may advise you to repeat the series of 6 treatments
in 3 days for a second time (starting on the same day of the week as when
you first used Condyline). If necessary, this treatment programme may
need to be repeated for a third, fourth and fifth week.
If the solution gets into your eyes, immediately bathe them with water
or with an appropriate eye cleaning solution if available. Do not keep
bathing the eyes as this may cause irritation. In any case, inform your
doctor straight away.
If you use more Condyline than you should
If you accidentally apply too much medicine or get it in the wrong place,
wash the affected area well with soap and water. There is a risk of
systemic toxicity if you use excessive amounts of Condyline for a long time.
If you have done this, you should tell your doctor. If someone happens to
drink the solution, contact their doctor or nearest Accident & Emergency
Department immediately.
If you forget to use Condyline
If you miss a treatment, apply it as soon as you remember. If it is nearly
time for your next application, skip the missed dose and continue using
Condyline as your doctor has directed.
If you have any further questions on the use of this product, ask your
doctor or pharmacist.
4. Possible side effects
Like all medicines, Condyline can cause side effects, although not
everybody gets them.
Side effects of Condyline are:
• Inflammation of the foreskin and head of the penis
• Local irritation of the vagina
• Mild irritation of your warts shortly after applying the solution. This may
include itching, burning, pain, redness or ulcers on the skin
• Although it is unlikely, some people may experience an allergic reaction
to the active ingredient podophyllotoxin - this may be severe and painful
redness or irritation, or any other unexpected pain.
Reporting of side effects
If you get any side effects, talk to your doctor. This includes any possible
side effects not listed in this leaflet. You can also report side effects
directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By
reporting side effects you can help provide more information on the safety
of this medicine.
5. How to store Condyline
Keep out of the reach and sight of children.
The product should be stored at room temperature (25°C), away from
naked flames.
Do not use Condyline after 6 weeks from the date you first opened the
bottle. Observe the expiry date which is printed on the carton and bottle.
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 to protect the environment.
6. Further information
What Condyline contains
The active substance is: podophyllotoxin 0.5% w/v.
The other substances are: lactic acid, sodium lactate and alcohol (96%).
(See Section 2 ‘Important information about some of the ingredients of
Condyline‘).
What Condyline looks like and contents of the pack
Each 5ml pack of Condyline contains 3.5 ml of clear, colourless solution
in a glass bottle fitted with a child resistant closure, as well as a supply of
special plastic applicator sticks.
Marketing Authorisation Holder
Manufacturer
Takeda Pharma A/S
Takeda Austria GmbH
Dybendal Allé 10
St Peter-Strasse 25
2630 Taastrup 4020 Linz
Denmark Austria
This leaflet was last approved in 05/2015.

1128342
1505 9
Code 671

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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