Pharmacy Guide

Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.

Pharmacy Guide

Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.

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Warticon Solution

⚠ This medicine appears to have been discontinued

The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.

If you were prescribed this medicine, other products containing Podophyllotoxin may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.

Active substance: Podophyllotoxin
Source: electronic medicines compendium (emc)
Official leaflet: Read the PIL on emc

What it is and what it is used for

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 take it

e 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. 1

 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 take it

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. 2

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 it

Warticon

  • Keep this medicine out of the sight and reach of children.
  • 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.
  • Store Warticon at room temperature (below 25°C). Keep the container tightly closed when not in use.
  • Contents are flammable. Keep Warticon away from all sources of fire, flame and heat. 3

• •

Do not leave Warticon in direct sunlight. 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

What Warticon contains

  • The active ingredient is podophyllotoxin 0.5% w/v.
  • The other ingredients are phosphoric acid, ethanol, Patent Blue V (E131) and purified water. What Warticon looks like and contents of the pack Each pack of Warticon contains a bottle of Warticon Solution and a tub of double-ended applicators. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Phoenix Labs Suite 12, Bunkilla Plaza, Bracetown Business Park, Clonee, County Meath, Ireland Manufacturer: Delpharm Bladel B.V. Industrieweg 1,5531 AD Bladel, The Netherlands or Stiefel Laboratories (Ireland) Ltd. Finisklin Business Park, Sligo, Ireland Other formats: To listen to or request a copy of this leaflet in Braille, large print or audio please contact: Phoenix Labs Suite 12, Bunkilla Plaza, Bracetown Business Park, Clonee, County Meath, Ireland This leaflet was last revised in May 2020 PL No 35104/0024 Warticon is a registered trademark of Phoenix Labs. (Phoenix Logo)

4

Frequently asked questions about Warticon Solution

How do I take Warticon Solution?

Warticon Solution comes as solution. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.

What is the active substance in Warticon Solution?

The active substance in Warticon Solution is podophyllotoxin.

Where does this information come from?

This leaflet reproduces the patient information leaflet approved for Warticon Solution, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.

Can I get Warticon Solution without a prescription?

Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.

About this leaflet

The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.

Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

Medicines with the same active substance: Podophyllotoxin (2 medicines)
See every medicine containing this substance, or browse the full A–Z of active substances.
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
Technical information intended for healthcare professionals (doctors and pharmacists). The Summary of Product Characteristics (SmPC) is the official document approved by the MHRA/EMA. It does not replace the patient leaflet or a doctor’s advice.

4.1. Therapeutic indications

For the topical treatment of condylomata acuminata affecting the penis or 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 cm2, it is recommended that treatment takes place under the direct supervision of a healthcare professional.

Avoid applying the solution to warts occurring on mucous membranes of the genital area (including the urethra, rectum and vagina).

Avoid applying the solution to surrounding healthy tissue.

Avoid contact with eyes. Should the solution accidentally come into contact with the eye, the eye should be thoroughly rinsed with water and medical advice sought.

Occlusive dressings should not be used on areas treated with the solution.

Local irritation may occur on the second or third day of application associated with the start of wart necrosis. In most cases, the reactions are mild. If severe local skin reactions occur (bleeding, swelling, excessive pain, burning, itching) the solution should be washed immediately from the treatment area with mild soap and water, treatment discontinued and the patient advised to seek medical advice.

Warticon Solution is not recommended during pregnancy or in women of childbearing potential not using contraception (see section 4.6).

It is recommended that patients refrain from sexual intercourse while treating warts with the solution and until the skin has healed. If a patient does engage in sexual intercourse, a condom must be used.

4.5. Interaction with other medicinal products and other forms of interaction

None presently known.

4.6. Fertility, pregnancy and lactation

Pregnancy

There are limited data from the use of podophyllotoxin in pregnant women.

Although there is very limited systemic absorption from topically applied podophyllotoxin, antimitotic products such as podophyllotoxin are known to be embryotoxic. Warticon Solution is not recommended during pregnancy or in women of childbearing potential not using contraception.

Breastfeeding

There is insufficient information on the excretion of topically applied podophyllotoxin in human milk.

A risk to the newborns/infants cannot be excluded.

A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from podophyllotoxin therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.

4.7. Effects on ability to drive and use machines

None presently known.

4.8. Undesirable effects

The frequency of adverse reactions listed below is defined using the following convention: very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1,000, < 1/100); rare (≥ 1/10,000, < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Skin and subcutaneous tissue disorders

Very Common: Skin erosion, application site irritation (including erythema, pruritus, skin burning sensation)

Post-marketing data

The following adverse drug reactions are based on post-marketing reports. Since these reports are from a population of uncertain size and are subject to confounding factors, it is not possible to reliably estimate their frequency, however in reality systemic reactions are rarely seen.

Immune system disorders

Not known: Application site hypersensitivity

Skin and subcutaneous tissue disorders

Not known: Skin ulcer, scab, skin discoloration, blister, dry skin

General disorders and administration site conditions

Not known: Application site pain, swelling, application site bleeding

Injury, poisoning and procedural complications

Not known: Caustic injury, excoriation, wound secretion

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9. Overdose

While serious systemic effects have not been reported with the recommended dosage of topical podophyllotoxin, topical overdosage would be expected to increase systemic absorption of the drug and increase the potential for systemic effects, e.g. altered mental state and bone marrow suppression. Following oral ingestion, podophyllotoxin may also cause severe gastroenteritis.

Treatment

If topical overdosage occurs, podophyllotoxin should be washed immediately from the treatment area and symptomatic and supportive therapy initiated.

Treatment of oral podophyllotoxin poisoning is symptomatic and should include supportive care.

Further management should be as clinically indicated or as recommended by the National Poisons Centre, where available.

🇷🇴 Known in Romania as

Medicines sold in Romania with the same active substance: Cunoscut în România ca

⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.

  • CONDYLINE prescriptionPODOPHYLLOTOXINUM · skin / topical

Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →

🇵🇱 Known in Poland as

Medicines sold in Poland with the same active substance: W Polsce znany jako

  • CondylinePodophyllotoxinum · taken by mouth

Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →

💬 Ask about this leaflet

Ask anything about Warticon Solution. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.

Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.

Medicines containing Podophyllotoxin

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