VERRUCUTAN 5 mg/g + 100 mg/g CUTANEOUS SOLUTION

Introduction

Package Leaflet: Information for the User

Verrucutan 5 mg/g + 100 mg/g Cutaneous Solution

Fluorouracil/Salicylic Acid

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.

Contents of the pack

1. What is Verrucutan and what is it used for
2. What you need to know before you use Verrucutan
3. How to use Verrucutan
4. Possible side effects
5. Storage of Verrucutan
6. Contents of the pack and other information

1. What is Verrucutan and what is it used for

Verrucutan is a therapeutic agent for warts.

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

2. What you need to know before you use Verrucutan

Do not use Verrucutan

• if you are allergic to fluorouracil, salicylic acid or any of the other ingredients of this medicine (listed in section 6).
• if you are breastfeeding.
• if you are pregnant or if you cannot rule out the possibility of pregnancy with certainty.
• in infants under 1 year of age.
• if you know you have altered kidney function
• if you are using certain antiviral medications to treat chickenpox or shingles (shingles therapy).

Do not use Verrucutan if you are currently being treated with brivudine, sorivudine and/or similar substance groups as part of shingles treatment, or if you have been treated in the last 4 weeks. The active ingredient fluorouracil, in combination with brivudine, sorivudine and its derivatives, can significantly increase the side effects of Verrucutan. You may not start treatment with fluorouracil for at least 4 weeks after completing shingles treatment with brivudine or sorivudine. If you are or have recently been 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 that you do not have dihydropyrimidine dehydrogenase (DPD) enzyme activity (complete DPD deficiency).

Be careful when using Verrucutan if you are taking phenytoin for epileptic seizures. If you are taking phenytoin, the combined use of Verrucutan may lead to 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 upper layer are affected by warts, you should apply Verrucutan less frequently and have the treated area medically reviewed more frequently, as this can cause scarring.

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

Verrucutan should not come into contact with textiles or acrylics (e.g. acrylic bathtubs) during use. The solution can cause irreversible stains.

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

Keep away from fire and flames.

Verrucutan should not be used on bleeding lesions.

Children

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

Other medicines and Verrucutan

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicines.

This is especially important because when several medicines are taken at the same time, the effect of the individual medicines can become stronger or weaker.

Do not use Verrucutan if you are taking or have taken certain medicines for treating viral diseases such as chickenpox or shingles (brivudine, sorivudine or their derivatives) in the last 4 weeks.

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

Due to the possible absorption of salicylic acid, interactions with methotrexate (a medicine used to treat certain rheumatic diseases, cancer or severe psoriasis) and sulfonylureas (contained in some hypoglycemic medicines (antidiabetics)) are possible.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Verrucutan should not be used during breastfeeding, pregnancy and if the possibility of pregnancy cannot be ruled out with certainty.

Driving and using machines

No special precautions are required.

Verrucutancontainsdimethyl sulfoxide and alcohol (ethanol)

This medicine may cause skin irritation because it contains dimethyl sulfoxide.

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

It may cause a burning sensation on damaged skin.

3. How to use Verrucutan

Follow exactly the administration instructions of this medicine given 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

For 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 a suitable product. It is advisable to pass the spatula over 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 more precise application. Before each new application of Verrucutan, you should remove the existing film coating by peeling it off.

For 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 skin. The total treatment area should not exceed 25 cm2.

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

Duration of treatment

The average duration of treatment is 6 weeks. After successful treatment, treatment should be continued for about one more week.

Tell your doctor or pharmacist if you think 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested. It is recommended to take the packaging and the package leaflet of the medicine to the healthcare professional.

If you forget to useVerrucutan

Do not use a double dose to make up for forgotten doses. Continue applying as prescribed by your doctor or as described in this package leaflet.

If you stop treatment with Verrucutan

In this case, contact your doctor.

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 gets 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 suppuration on the skin at the application site. The skin may flake and erosive skin reactions (loss of the upper skin tissue) 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 a strong burning sensation, so that you should interrupt treatment.
• Verrucutan contains salicylic acid. This component may cause mild signs of irritation, such as skin inflammation (dermatitis) and hypersensitivity reactions (contact allergic reactions). These signs of irritation may also appear as itching, redness and blisters beyond the application site.
• Around the wart, there may be a white discoloration and flaking of the skin.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Verrucutan

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 label of the bottle and on the carton after “EXP”. The expiry date is the last day of the month stated.

Do not store above 30°C.

Do not refrigerate or freeze.

Once opened, the product is stable for 6 months.

The bottle should be closed tightly after use. Otherwise, the product will dry out quickly and can no longer 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 via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

Caution: flammable; keep away from fire and flames.

6. Contents of the pack and other information

Composition ofVerrucutan

The active ingredients are: fluorouracil and salicylic acid.

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

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

Appearance of the product and contents of the pack

Verrucutan is a cutaneous solution; clear, colorless tending to slightly orange and is available in brown glass bottles with child-resistant screw caps with a polyethylene spatula, containing 13 ml (12.3 g) and 14 ml (13.2 g).

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Mibe Pharma España S.L.U.

C/Amaltea 9, 4ª planta, letra B,

28045, Madrid

Spain

Manufacturer:

Mibe GmbH Arzneimittel

Münchener Strasse 15

06796 – Brehna

Germany

Or

Sun-Farm Sp. z o.o.

Ul. Dolna 21, Lomianki

Mazowieckie 05-092

Poland

Date of last revision of this package leaflet: May 2022

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).

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