CONDYLINE 0.5 % W/V CUTANEOUS SOLUTION 0.5% %w/v Cutaneous Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

PODOPHYLLOTOXIN

Available from:

Takeda Danmark A/S

INN (International Name):

PODOPHYLLOTOXIN

Dosage:

0.5% %w/v

Pharmaceutical form:

Cutaneous Solution

Prescription type:

Product subject to prescription which may be renewed (B)

Authorization status:

Authorised

Authorization date:

0000-00-00

Patient Information leaflet

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 a solution containing 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.
The warts 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 already using any products containing podophyllin
• on skin that is bleeding or inflamed, or on open wounds after an
operation
• on healthy skin, eyes or your face as you may get severe
irritation
• if you are pregnant or breast-feeding
• if you are a child under 12 years.
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 4 x 4 cm. You should only use this medicine under
close medical supervision.
• This medicine can cause systemic toxicity (side effects that can
affect the whole body). The risk of this is increased b

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Condyline 0.5 % w/v Cutaneous Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Condyline Solution contains 0.5 % w/v podophyllotoxin in bottles of 3.5 ml.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cutaneous Solution
Each pack of Condyline Solution consists of 3.5 ml of a clear, colourless, alcoholic cutaneous solution of 0.5% w/v
podophyllotoxin.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the topical treatment of condylomata acuminata (warts) affecting the penis or the female external genitalia.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
By topical administration.
ADULTS AND THE ELDERLY
Apply twice daily for three days directly to the warts. Allow to dry after treatment.
Use the applicator provided, applying not more than 50 applicators-full for each treatment.
This three day treatment may be repeated, if necessary, at weekly intervals for a maximum of five weeks of treatment.
Only a small area or number of warts should be treated at any one time.
CHILDREN
Not recommended in children under 12 years of age.
4.3 CONTRAINDICATIONS
Podophyllotoxin is contraindicated in patients with the following conditions/diseases:
-
known or suspected hypersensitivity to podophyllotoxin or to any of the other ingredients (see section 6.1);
-
inflamed or bleeding lesions;
-
open wounds following surgical procedures;
-
in combination with other podophyllin containing preparations;
-
pregnant or breast-feeding women (see section 4.6);
-
children under 12 years of age.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Avoid contact with healthy skin as well as the eyes and face because of severe irritation.
Lesions in the female and lesions greater than 4cm
2
in the male should be treated under direc