Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
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.
for Warticon Cream contains a medicine called podophyllotoxin. This is a plant extract which belongs to a group of medicines called 'antivirals'. Warticon Cream is used to treat genital warts. It is used for warts on the penis in men or external warts on the vagina in women. 2.
e Warticon Cream Do not use Warticon Cream if:
What to avoid while using Warticon Cream
Warticon Cream Always use Warticon Cream exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Using Warticon Cream
If you get Warticon Cream in your eyes or if you swallow it
Like all medicines, Warticon Cream can cause side effects, although not everybody gets them. If you experience any of the following serious side effects, stop using Warticon Cream and seek medical attention:
Contact your doctor as soon as possible.
Very common side effects These may affect more than 1 in 10 people:
Warticon Cream
6.
What Warticon Cream contains
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Phoenix Labs Suite 12, Bunkilla Plaza, Bracetown Business Park, Clonee, County Meath, Ireland Manufacturer: Delpharm Bladel BV Industrieweg 1, 5531 AD Bladel, The Netherlands OR Phoenix Healthcare Limited Unit 31, 2nd Avenue, Cookstown Industrial Estate, Dublin 24, D24 TP60, Ireland OR LABORATORI FUNDACIÓ DAU Pol. Ind. Consorci Zona Franca. c/ C, 12-14 08040 Barcelona Spain
[Only the site responsible for batch release will be listed on the PIL included in the pack].
Other formats: If this leaflet is difficult to see or read or you would like it in a different format, please contact: Phoenix Labs, Suite 12, Bunkilla Plaza, Bracetown Business Park, Clonee, County Meath, Ireland. This medicinal product is authorised in the Member States of the EEA under the following names: Ireland: Warticon 0.15% w/w Cream Spain: Wartec Crema The Netherlands: Wartec, crème 1,5 mg/g United Kingdom: Warticon 0.15% w/w Cream This leaflet was last revised in January 2023.
PL 35104/0023 PA 1113/017/001 Warticon is a registered trade mark of Phoenix Labs.
Warticon Cream comes as cream. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Warticon Cream is podophyllotoxin.
This leaflet reproduces the patient information leaflet approved for Warticon Cream, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
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.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Route of administration: Topical
For the topical treatment of condylomata acuminata affecting the penis or the external female genitalia.
The affected area should be thoroughly washed with soap and water, and dried prior to application.
Using a fingertip, the cream should be applied twice daily morning and evening (every 12 hours) for 3 consecutive days using only enough cream to just cover each wart. The cream should then be withheld for the next 4 consecutive days.
Application to the surrounding normal tissue should be avoided.
Residual warts should be treated with further courses of twice daily applications for three days at weekly intervals, if necessary for a total of 4 weeks of treatment.
Hands should be washed thoroughly after application.
Paediatric population
The safety and efficacy of topical podophyllotoxin have not been established in children under the age of 18.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Open or bleeding wounds.
Concomitant use with other podophyllotoxin containing preparations.
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 cream to warts occurring on mucous membranes of the genital area (including the urethra, rectum and vagina).
Avoid applying the cream to surrounding healthy tissue.
Avoid contact with eyes. Should the cream accidentally come into 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 cream.
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 cream should be washed immediately from the treatment area with mild soap and water, treatment discontinued and the patient advised to seek medical advice.
Warticon Cream 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 cream and until the skin has healed. If a patient does engage in sexual intercourse, a condom must be used.
This cream contains:
• methyl and propyl parahydroxybenzoate which may cause allergic reactions (possibly delayed).
• sorbic acid, stearyl alcohol and cetyl alcohol which may cause local skin reactions, (e.g. contact dermatitis).
• butyl hydroxyanisole which may cause local skin reactions (e.g.contact dermatitis), or irritation to the eyes and mucous membranes.
None presently known.
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 Cream 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.
None presently known.
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.
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.
Medicines sold in Romania with the same active substance: Cunoscut în România ca
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 →
Medicines sold in Poland with the same active substance: W Polsce znany jako
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
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 anything about Warticon Cream. 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.
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