Label: information for the user

Verrucutan 5 mg/g + 100 mg/g topical solution

Fluorouracil/ Salicylic acid

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

Verrucutan is a therapeutic agent for warts.

Verrucutan is used for common warts, warts on the soles of the feet (plantar warts) and flat warts (smooth warts, juvenile warts) on the arms and legs.

Do not use Verrucutan

• if you are allergic to fluorouracil, salicylic acid, or any of the other components of this medication (listed in section 6).
• if you are breastfeeding.
• if you are pregnant or if you cannot rule out the possibility of pregnancy.
• in infants under 1 year.
• if you know you have impaired renal function
• if you are using certain antiviral medications to treat chickenpox or shingles (herpes zoster therapy).

Do not use Verrucutan if you are currently being treated with brivudin, sorivudin, and/or similar substances as part of the treatment for shingles, or if you have been treated with them in the last 4 weeks. The active ingredient fluorouracil, in combination with brivudin, sorivudin, and their derivatives, may significantly increase the side effects of Verrucutan. You may not start treatment with fluorouracil for at least 4 weeks after completing shingles treatment with brivudin or sorivudin. If you are or have been recently treated for a shingles infection, inform your doctor about the medications you are taking.

Verrucutan is not indicated for use on large areas of skin (more than 25 cm2) and should not come into contact with the eyes and mucous membranes.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Verrucutan, if you know you do not have dihydropyrimidine dehydrogenase (DPD) enzyme activity (complete DPD deficiency).

Be careful when using Verrucutan if you are taking phenytoin for epilepsy. If you are taking phenytoin, the combined use of Verrucutan may cause an increase in phenytoin blood levels. For this reason, you should be monitored periodically to detect an increase in phenytoin blood levels.

If areas of the skin with a thin outer layer are affected by warts, you should apply Verrucutan less frequently and have the treated area checked by a doctor more frequently, as this may cause scarring.

Be aware that regular medical check-ups are required if your ability to feel touch, pain, and temperature is limited (sensory disorders, for example, due to diabetes).

Verrucutan should not come into contact with textiles or acrylics (for example, acrylic bathtubs) during use. The solution may cause irreversible stains.

Be aware that Verrucutan is flammable before the lacquer film has formed.

Avoid fire and flames.

Verrucutan should not be used on bleeding wounds.

Children

Verrucutan should not be used in infants under 1 year. Since the risk of overdose is greater in children than in adults, do not exceed the recommended treatment area and treatment frequency, especially in small children.

Other medications and Verrucutan

Inform your doctor or pharmacist if you are taking / using, have taken / used recently, or may need to take / use any other medication.

This is particularly important because, when several medications are taken at the same time, the effect of individual medications may become stronger or weaker.

Do not use Verrucutan if you are taking or have taken certain medications to treat viral diseases such as chickenpox or shingles (brivudin, sorivudin, or their derivatives) in the last 4 weeks.

You should be especially careful if you are taking medications for seizures (phenytoin). It is known from the systemic use of fluorouracil in cancer therapy that co-administration of phenytoin may lead to an increase in phenytoin levels.

Due to possible absorption of salicylic acid, interactions with methotrexate (a medication used to treat certain rheumatic diseases, cancer, or severe psoriasis) and sulfonylureas (contained in some antidiabetic medications) are possible.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Verrucutan should not be used during breastfeeding, pregnancy, and if you cannot rule out the possibility of pregnancy.

Driving and operating machinery

No special precautions are required.

Verrucutan containsdimethylsulfoxide and alcohol (ethanol)

This medication may cause skin irritation because it contains dimethylsulfoxide.

This medication contains 171.5 mg/g of alcohol (ethanol).

It may cause a burning sensation on injured skin.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Dose

Unless otherwise prescribed, Verrucutan is applied two or three times a day to each wart.

Method of administration

Cutaneous use.

Verrucutan should only come into contact with the wart and not with the surrounding healthy skin; when appropriate, the surrounding skin should be covered with a paste or ointment. If necessary, your doctor or pharmacist may recommend an appropriate product. It is advisable to pass the spatula through the neck of the bottle before applying it. For very small warts, you should use a toothpick or something similar instead of the spatula for a more precise application. Before each new application of Verrucutan, you should remove the existing film coating by peeling it off.

To warts around or under the nail, you should ensure that the nail is intact and that Verrucutan cannot penetrate the nail bed.

Verrucutan is not indicated for use on large areas of the skin. The total area of combined treatment should not exceed 25 cm2.

It is recommended that you consult your doctor regularly during treatment. Experience shows that, in many cases (for example, with warts or warts that protrude a lot), it is beneficial for your doctor to remove the dead tissue during treatment with Verrucutan.

Treatment duration

The average duration of treatment is 6 weeks. After a successful treatment, treatment should be continued for approximately another week.

Inform your doctor or pharmacist if you feel that the effect of Verrucutan is too strong or too weak.

If you use more Verrucutan than you should

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to useVerrucutan

Do not use a double dose to compensate for the missed doses. Continue applying as prescribed by your doctor or described in this leaflet.

If you interrupt the treatment with Verrucutan

In this case, contact your doctor.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Likeall medications, this medication may produce adverse effects, although not all people may experience them.

• Very Common(may affect more than 1 in 10 people): there may be redness of the skin, inflammation, irritation, burning, pain, and itching at the application site.
• Common(may affect up to 1 in 10 people): there may be bleeding, crust formation, and skin supuration at the application site. The skin may peel and erosive skin reactions (loss of the upper skin layer) may occur.
• Headache may occur.
• Uncommon(may affect up to 1 in 100 people): there may be skin inflammation, edema, and ulcers at the application site.
• In the eyes, there may be increased tear production, itching, and dry eyes.
• Rare(may affect up to 1 in 1,000 people): there may be intense burning sensation, requiring the treatment to be interrupted.
• Salicylic acid is contained in Verrucutan. This component may cause mild signs of irritation, such as skin inflammation (dermatitis) and contact hypersensitivity reactions (allergic contact reactions). These signs of irritation may also appear as itching, redness, and blisters beyond the application site.
• There may be a whitish discoloration and skin peeling in the area around the wart.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the bottle label and on the box after “CAD”. The expiration date is the last day of the month indicated.

Do not store above 86°F (30°C).

Do not refrigerate or freeze.

Once opened, the product is stable for 6 months.

The bottle must be closed tightly after use. Otherwise, the product will dry out quickly and cannot be used correctly. Do not use Verrucutan if it has dried out. Do not use Verrucutan if crystals have formed.

Medicines should not be disposed of through drains or in the trash. Deposit containers and unused medications at the SIGRE collection point at the pharmacy.Ask your pharmacist how to dispose of containers and unused medications. This will help protect the environment.

Warning: flammable; keep away from fire and flames.

Composition ofVerrucutan

The active principles are: fluorouracil and salicylic acid.

1 g of solution contains 5 mg of fluorouracil and 100 mg of salicylic acid.

The other components are: dimethyl sulfoxide, anhydrous ethanol, ethyl acetate, pyroxylin, poly (butyl methacrylate-co-methyl methacrylate) (80:20).

Appearance of the product and contents of the packaging

Verrucutan is a topical solution; transparent, colorless tending to slightly orangeand is available in brown glass bottles with screw caps with polyethylene child-resistant spatulas with 13 ml (12.3 g) and 14 ml (13.2 g).

It is possible that not all packaging sizes are marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Mibe Pharma España S.L.U.

C/Amaltea 9, 4th floor, letter B,

28045, Madrid

Spain

Responsible for manufacturing:

Mibe GmbH Arzneimittel

Münchener Strasse 15

06796 – Brehna

Germany

Or

Sun-Farm Sp. z o.o.

Ul. Dolna 21, Lomianki

Mazowieckie 05-092

Poland

Last review date of this leaflet: May 2022

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).

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