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Warticon Solution

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Document: leaflet MAH BRAND_PLPI 15814-1240 change

Package leaflet: Information for the patient

Warticon® Solution

(podophyllotoxin 0.5% w/v)

The medicine is available as the above name but will be

referred to as Warticon throughout this leaflet.

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 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/damage 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 course may be applied.

•    If any warts remain after 4 treatment courses, see your doctor.

•    Due to the flammable mature 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.

POM


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 eyes, 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 out of the sight and reach of children.

•    Do not store above 25°C. Store in the original container. Keep the container tightly closed when not in use.

•    Contents are flammable. Keep away from all sources of fire, flame and heat. Do not leave in direct sunlight.

•    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 protect the environment.

•    If your medicine become discoloured or show signs of any deterioration, consult your doctor or pharmacist who will tell you what to do.

6. Contents of the pack and other information

What Warticon contains

•    The active ingredient is podophyllotoxin 0.5% w/v.

•    Also contains patent blue V (E131), phosphoric acid, ethanol, and purified water.

What Warticon looks like and contents of the pack

Each pack contains a 3ml amber glass bottle with a white plastic child-resistant closure and a tamper evident seal containing a blue solution and a plastic tub containing plastic double-ended applicators.

Manufactured by Stiefel Laboratories (Ireland) Ltd, Sligo, Ireland OR Famar Nederland B.V., AD Bladel, The Netherlands.

Procured from within the EU and repackaged by the Product Licence holder: O.P.D. Laboratories Ltd., Unit 6 Colonial Way, Watford, Herts WD24 4PR.

PL: 15814/1240

Leaflet revision and issue date (Ref): 05.01.2016.

Warticon is a registered trademark of Stiefel Laboratories, Inc. To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.