Warticon
Patient Information Leaflet
Warticon® Solution
(podophyllotoxin)
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.
The name of your medicine is Warticon Solution, but will be referred to as Warticon throughout the remainder of the leaflet.
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 need to have this medicine applied by your doctor or nurse in a clinic.
Warticon Solution is only to be used on the affected skin.
Don't take Warticon Solution by mouth.
Don't apply Warticon Solution to warts on the inside of the penis, vagina or rectum. Warticon Solution should only be applied to warts on the outside (external) skin.
Avoid applying Warticon Solution to healthy skin surrounding the wart.
Avoid getting Warticon Solution in your eyes as it may cause irritation, If you accidentally get Warticon Solution in your eyes rinse immediately with plenty of water and see a doctor.
Don't put a dressing (such as a plaster) over the top of the
area treated with Warticon Solution.
^ Check with your doctor if you think any of these may apply to you.
What to avoid while using Warticon Solution
• It is advisable to avoid sex during treatment with Warticon Solution. You should wait until your warts have gone and your skin has healed
• Genital warts are contagious. You can give them to, or get
them from, a sexual partner.
^ If you do have sex, you must use a condom to help prevent the spread of genital warts and to protect your partner from coming into contact with podophyllotoxin (since it is irritant).
Other medicines and Warticon Solution Tell your doctor or pharmacist if you are taking any other medicines, if you have taken any recently, or if you start taking new ones. This includes medicines bought without a prescription.
Children
The use of Warticon Solution is not recommended for children under 18 as use in this age has not been established.
Pregnancy and breast-feeding
Warticon Solution is not recommended for use during pregnancy.
• Tell your doctor if you are pregnant or planning to become pregnant
• Use a reliable method of contraception to prevent pregnancy, while you are using Warticon Solution
• If you do become pregnant during treatment with Warticon Solution, tell your doctor.
Breast-feeding is not recommended during treatment with Warticon Solution. Discuss with your doctor whether you choose to breast-feed or to use podophyllotoxin.
3. How to use Warticon
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Use this medicine only on your skin.
How much to use
• Apply Warticon twice a day, in the morning and evening (every 12 hours) for 3 days.
• Do not apply any Warticon for the next 4 days. This completes one treatment course.
• When you apply Warticon Solution, after two or three days you may notice mild irritation of the areas treated. This shows that Warticon Solution is starting to work. However, Warticon Solution can cause severe skin reactions. If this occurs, stop using Warticon Solution and seek medical attention. See 'Possible side effects' in Section 4 for further information. If you still have any warts remaining 7 days after you have started using Warticon, repeat the treatment course (twice a day for 3 days followed by 4 days when you do not apply it).
• A maximum of 4 treatment courses may be applied.
• If any warts remain after 4 treatment courses, see your doctor.
• Due to the flammable nature of Warticon solution, you should avoid smoking or being near an open flame while you're applying Warticon solution, and immediately after you've used it.
How to apply Warticon Solution
1. Wash the affected areas with soap and water. Dry the area gently with a clean towel.
2. Use a new applicator each time you apply Warticon Solution.
3. Dip the 'Loop' end of the applicator into the Warticon Solution. If you have a large wart (no larger than a postage stamp) or lots of warts in a small area, dip the 'Spatula' end of the applicator into the solution.
4. Apply the solution to a wart until it is just covered and allow to dry. Be careful not to get the Warticon onto healthy skin. If this happens, wash the solution off with soap and water.
5. Repeat steps 3 and 4 for each wart. Allow all the skin treated with Warticon Solution to dry before letting other skin touch the affected area.
6. Wash your hands thoroughly after using Warticon Solution.
7. Make sure you screw the lid back on tightly.
Spatula end for treatment of large or lots of warts In a small area
If you get Warticon in your eyes or if you swallow it
• If you get Warticon in your eye, rinse the eye thoroughly with water and see your doctor.
• If you accidentally get Warticon Solution in your mouth, rinse at once with water.
• If you accidentally swallow some of the Warticon, see your doctor or go to hospital straight away. Take the bottle of Warticon with you so that the doctor knows what you have swallowed.
If you use too much Warticon Solution
If you accidentally use too much solution, wash it from the
treatment area immediately and see a doctor.
If you forget to use Warticon Solution
Apply Warticon Solution as soon as you remember. If it is nearly time for your next dose, wait until then.
Don't use a double dose of the medication.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody will get them.
If you experience any of the following serious side effects, stop using Warticon Solution and seek emergency medical attention:
• severe burning, stinging, pain, bleeding, itching or swelling of the treated skin. If these symptoms occur, wash Warticon Solution from your skin with soap and water immediately.
^ Contact your doctor immediately.
Very common side effects
These may affect more than 1 in 10 people:
• wearing away of the top layers of the skin, application site irritation including redness, itching, burning sensation
Other side effects with frequencies that cannot be estimated from the available data include:
• allergic reaction, pain, swelling, bleeding
• damage to or loss of the top layer of skin, weeping wound
• skin ulcer, scab, skin discoloration, dry skin, blister.
These effects can occur on the area of skin where you use the solution.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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 Warticon
Keep this medicine out of the sight and reach of children.
Do not store above 25°C. Keep the container tightly closed when not in use. Do not leave in direct sunlight. Avoid flame and heat. Contents are flammable.
If the solution shows any signs of discolouration or deterioration consult your pharmacist for advice.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
Contains 0.5% w/v podophyllotoxin.
Also contains: phosphoric acid, ethanol, Patent Blue V (E131) and purified water.
Each pack contains a 3ml amber glass bottle with white child resistant closure containing blue solution and a tub of double-ended applicators.
POM
PL 20774/1414 Warticon Solution
Manufactured by: Stiefel Laboratories (Ireland) Ltd, Finisklin Business Park Sligo, Ireland and Famar Nederland B.V. Industrieweg 1 5531 AD BLADEL, The Netherlands. Procured from within the EU. Product Licence Holder: Quadrant Pharmaceuticals Ltd, Lynstock House, Lynstock Way, Lostock, Bolton, BL6 4SA. Repackaged by Maxearn Ltd, Bolton,
BL6 4SA.
Warticon is a registered trademark of Stiefel Laboratories, Inc.
Leaflet revision Date: 10th June 2015
PP1/1414/V3