Warticon

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

PODOPHYLLOTOXIN

Available from:

Glaxo SmithKline UK Limited 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

ATC code:

D06BB04

INN (International Name):

PODOPHYLLOTOXIN 0.5 % (W/V)

Pharmaceutical form:

CUTANEOUS SOLUTION

Composition:

PODOPHYLLOTOXIN 0.5 % (W/V)

Prescription type:

POM

Therapeutic area:

ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE

Authorization status:

Withdrawn

Authorization date:

2005-11-18

Patient Information leaflet

 
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT 
_ _
WARTICON
®

podophyllotoxin 0.5% w/v solution 

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT 
INFORMATION FOR YOU. 
•  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 only. Do not pass
it on to others. It may harm them, even if 
their signs of illness are the same as yours. 
•  If you get any of side effects, talk to your doctor
or pharmacist. This includes any possible side effects 
not listed in this leaflet. See section 4. 
_ _
WHAT IS IN THIS LEAFLET: 
1. 
What Warticon is and what it is used for 
2. 
What  you need to know before you use Warticon  
3. 
How to use Warticon 
4. 
Possible side effects 
5. 
How to store Warticon 
6. 
Contents of the pack and other  information 

1. 
WHAT WARTICON IS AND WHAT IT IS USED FOR 
Warticon contains a medicine called podophyllotoxin. This is a plant
extract which belongs to a group of 
medicines called ‘antivirals’. 

Warticon is used to treat genital warts. It is used for warts on the
foreskin of the penis in men or external 
warts on the vagina in females. 

2. 
WHAT YOU NEED TO KNOW BEFORE YOU USE WARTICON 
DO NOT USE WARTICON IF: 
•  you are allergic to podophyllotoxin or any of
the other ingredients of this medicine (listed in Section 6) 
•  your warts are on areas of broken/damaged or bleeding skin 
•  you are already using another medicine
containing podophyllotoxin. 

Do not use Warticon if any of the above apply to you. If you are
not sure, talk to your doctor or pharmacist 
before using this medicine. 

WARNINGS AND PRECAUTIONS 
Talk to your doctor before using this Warticon if: 
•  your warts cover an area larger than a 4 centimetre area
(approximately the size of a postage stamp). You 
may nee

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 
Warticon 
2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Podophyllotoxin 5 mg/ml (0.5% w/v).  The
quality of podophyllotoxin fulfills in-
house specification. 
3 
PHARMACEUTICAL FORM 
Topical solution 
4 
CLINICAL PARTICULARS 
4.1 
THERAPEUTIC INDICATIONS 
For the topical treatment of condylomata acuminata affecting the
penis and the 
external female genitalia. 
4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 
The affected area should be thoroughly washed with soap and
water, and dried prior 
to application. 
Warticon should be applied twice daily, morning and
evening (every 12 hours) for 3 
consecutive days.  The treatment should then be withheld for the
next 4 consecutive 
days.   

Application to the surrounding normal tissue should be avoided. 

If residual warts persist, this 3-day treatment may be repeated
weekly until there is no 
visible wart tissue or for a total of 4 weeks of treatment. 
Warticon solution should be applied to the warts with the
applicator supplied with the 
solution.   

Due to the flammable nature of Warticon solution, patients should
avoid smoking or 
being near an open flame
during application and immediately after use. 

The solution should be allowed to dry before opposing skin
surfaces are returned to 
their normal position. 

_Paediatric population_ 
The safety and efficacy of topical podophyllotoxin have
not been established in 
children under the age of 18. 
4.3 
CONTRAINDICATIONS 
Hypersensitivity to the active
substance or any of the excipients listed in section 6.1.  

Open or bleeding wounds. 

Concomitant use with other podophyllotoxin
containing preparations.   
4.4 
SPECIAL WARNINGS AND PRECAUTIONS FOR USE 
Where the area of treatment is greater than 4 cm
2
, it is recommended that treatment 
takes pla