Verrumal

Leaflet attached to the packaging: information for the user

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Verrumal (Verruca Hermal)

(100 mg + 5 mg)/g (94.80 mg/ml + 4.74 mg/ml), solution for the skin
Acidum salicylicum + Fluorouracilum
Verrumal and Verruca Hermal are different trade names for the same drug.

It is necessary to carefully read the contents of the leaflet before using the drug, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This drug has been prescribed for a specific person. It should not be given to others. The drug may harm another person, even if the symptoms of their disease are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Verrumal and what is it used for
• 2. Important information before using Verrumal
• 3. How to use Verrumal
• 4. Possible side effects
• 5. How to store Verrumal
• 6. Contents of the packaging and other information

1. What is Verrumal and what is it used for

Verrumal is a solution for application to the skin. It contains the active substances: fluorouracil and salicylic acid.
Fluorouracil is a drug from the group of cytostatics, which inhibit cell growth (cytostatic factor).
As a result, fluorouracil inhibits the multiplication of viruses that cause the formation of warts, as well as the growth of warts.
Salicylic acid softens and exfoliates the horny layer of the skin, facilitating the penetration of fluorouracil into the warts.

Indications

The drug is used to treat common warts, flat warts (juvenile), and plantar warts.

2. Important information before using Verrumal

When not to use Verrumal

• if the patient is allergic to salicylic acid, fluorouracil, or any of the other components of this drug (listed in section 6),
• during breastfeeding,
• during pregnancy or in women who are likely to be pregnant,
• in children under 6 years of age,
• in patients with renal failure,
• together with drugs such as brivudine, sorivudine, and other nucleoside analogs (antiviral drugs),

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• Verrumal is not intended for use on large areas of skin (the skin area treated should not be larger than 25 cm of body surface).

Verrumal must not come into contact with the eyes or mucous membranes.

Warnings and precautions

Before starting treatment with Verrumal, you should discuss it with your doctor or pharmacist.

• If the patient has been diagnosed with a lack of dihydropyrimidine dehydrogenase (DPD) enzyme activity (complete DPD deficiency), it is essential not to use a higher dose of Verrumal than indicated in section 3 of this leaflet.
• The drug should not be used in sensitive areas, such as the mouth, nose, and lips.
• One should avoid contact between Verrumal and the skin surrounding the warts.
• In case of improper use of the drug (e.g., applying the solution to the surrounding skin), local burning and erosion may occur, leaving temporary discoloration.
• If an inflammatory reaction occurs on the skin surrounding the wart, you should contact your doctor, as treatment should be discontinued in such cases.
• In the case of treating a very large number of warts, photosensitivity may occur.
• Verrumal can be used no earlier than 4 weeks after stopping the use of brivudine, sorivudine, and other nucleoside analogs (antiviral drugs), as these drugs may significantly increase the concentration of fluorouracil in the blood and thus enhance its toxicity.
• In patients treated simultaneously with phenytoin (an antiepileptic drug) and fluorouracil, the concentration of phenytoin in the blood should be regularly monitored.
• The excipient contained in the drug - dimethyl sulfoxide - may cause skin irritation.
• If the warts are located in an area of skin with a thin layer of epidermis, the drug should be applied less frequently, and the doctor should monitor the treatment more closely, as the salicylic acid in Verrumal may cause scarring.
• If the warts are heavily keratinized, it may be beneficial to treat them first with salicylic acid patches.
• If the patient has sensory disturbances (e.g., due to diabetes), it is necessary to closely monitor the treatment by the doctor.
• Verrumal should not be used in the case of bleeding skin lesions.
• After each use of the drug, the bottle should always be tightly closed, as the drug dries out quickly when the bottle is open and can no longer be used properly. The drug should not be used if crystals appear in it.
• When applying the drug, one should be careful not to stain clothing or acrylic products (e.g., an acrylic bathtub), as the drug creates stains that cannot be removed.

WARNING:The drug is flammable! It should be kept away from fire and not used near an open flame, a lit cigarette, or certain devices (e.g., hair dryers).

Children and adolescents

Verrumal is contraindicated for use in children under 6 years of age.

Verrumal and other drugs

You should tell your doctor or pharmacist about all the drugs you are currently taking or have recently taken, as well as the drugs you plan to use.
You should inform your doctor in case of treatment with:

• antiviral drugs from the group of nucleoside analogs, such as brivudine and sorivudine (see above),

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• phenytoin (an antiepileptic drug, see above),
• methotrexate (a cytostatic drug) and sulfonylurea derivatives (antidiabetic drugs), due to possible interactions with salicylic acid.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before using this drug.
Using the drug during pregnancy and breastfeeding is contraindicated.
The drug should not be used in women who are likely to be pregnant.

Driving and using machines

Verrumal has no effect on the ability to drive vehicles or operate machines.

Important information about some components of Verrumal

The substance contained in the drug - dimethyl sulfoxide - may cause skin irritation.
This drug contains 160 mg of alcohol (ethanol) per gram of solution. The drug may cause burning of damaged skin.

3. How to use Verrumal

This drug should always be used in accordance with the doctor's or pharmacist's recommendations. In case of doubts, you should consult a doctor or pharmacist.
The drug is intended for use on the skin.
Verrumal is usually applied 2 to 3 times a day to each wart.
The drug should be applied only to the wart. The drug should not be applied to healthy skin. The skin surrounding the wart can be protected from the drug by applying a cream or ointment. It is recommended to clean the brush on the neck of the bottle before applying the drug.
In the case of very small warts, to apply the drug precisely, you can use a toothpick or a sharpened match instead of a brush.
Before each application of Verrumal, you should first remove the remaining coating from the previous application. Using warm water may be helpful when removing the coating.
Verrumal should not be applied to hairy skin surfaces. This may lead to the sticking of hair to the treated skin surface, making it difficult to remove the coating. When applying the drug to hairy skin surfaces, you should shave them first or use other suitable hair removal methods.
In the case of periungual warts, especially subungual warts, you should be careful not to damage the nail matrix and not to let Verrumal penetrate into the nail bed.
The maximum treated skin surface should not be larger than 25 cm of body surface.
Usually, the treatment period is 6 weeks. You should remember to use the drug daily and regularly.
After the disappearance of the disease changes, the drug should be used for another week.
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In some cases, e.g., with strongly protruding common warts or warts on the feet, after treatment with Verrumal, it is recommended to remove the remaining dead tissue by a doctor.

Children and adolescents

Verrumal is contraindicated for use in children under 6 years of age.
If you feel that the effect of the drug is too strong or too weak, you should consult a doctor or pharmacist.

Using a higher dose of Verrumal than recommended

In the case of proper use of the drug, i.e., in accordance with the recommended dosage, poisoning with salicylic acid or fluorouracil is unlikely.
In case of overdose or accidental ingestion of the drug, you should immediately contact a doctor.
Significant exceeding of the recommended maximum permissible treatment area or increasing the frequency of application increases the risk of salicylic acid poisoning, especially in small children.

Missing a dose of Verrumal

You should remember to use the drug daily and regularly. You should not use a double dose to make up for a missed application.

Stopping the use of Verrumal

The average treatment period is 6 weeks. After the disappearance of the disease changes, the drug should be used for another week. Early discontinuation of treatment may result in the therapy not being effective.
You should not stop the treatment without consulting a doctor.
In case of any further doubts related to the use of this drug, you should consult a doctor or pharmacist.

4. Possible side effects

Like all drugs, this drug can cause side effects, although they may not occur in everyone.
Side effects may occur with the following frequency:

• at the application site: redness (severe skin redness), inflammation, irritation (including burning), pain, itching.

Very common– may occur more frequently than in 1 in 10 people

• headache,
• skin peeling,
• at the application site: bleeding, erosion (superficial skin damage), scab.

Common– may occur no more frequently than in 1 in 10 people

• dry eye, itching of the eye, increased tearing,
• at the application site: skin inflammation, swelling, ulceration.

Uncommon– may occur no more frequently than in 1 in 100 people

Due to the strong effect of the drug, which softens the horny layer of the epidermis, white discoloration and skin peeling may occur, especially in the area of the warts.
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Due to the content of salicylic acid in the drug, mild irritation symptoms may occur, such as skin inflammation and contact allergic reactions, in the form of itching, redness, and small blisters, even outside the area of contact between the drug and the skin.
If any of the side effects worsen or if you experience any side effects not listed in the leaflet, you should inform your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl.
By reporting side effects, you can help gather more information on the safety of the drug.

5. How to store Verrumal

Store in a place invisible and inaccessible to children.
Do not store at a temperature above 25°C.
Store at a temperature below 10°C only for a short time.
Longer storage at a temperature below 10°C may cause fluorouracil crystallization.
After the first opening of the packaging (bottle) - use within 6 months.
The drug is flammable! It should be kept away from fire and not used near an open flame, a lit cigarette, or certain devices (e.g., hair dryers).
Do not use this drug after the expiry date stated on the packaging. The expiry date indicates the last day of the given month.
Drugs should not be disposed of in the sewage system or household waste containers. You should ask your pharmacist how to dispose of unused drugs. This will help protect the environment.

6. Contents of the packaging and other information

What Verrumal contains

The active substances of the drug are: salicylic acid and fluorouracil.
1 g of solution contains active substances: 100 mg of salicylic acid and 5 mg of fluorouracil.
The other ingredients (excipients) are: ethyl acetate, ethanol, dimethyl sulfoxide, butyl methacrylate copolymer (80:20), pyroxylin.

What Verrumal looks like and what the packaging contains

Verrumal is a clear, colorless to light yellow-orange solution for the skin.
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The available packaging of the drug is a colorless glass bottle with a screw cap and a brush, containing 13 ml of solution, placed in a cardboard box.
To obtain more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Greece, the country of export:

Olvos Science AE, Eleftherias 4, 145 64 Kifisia, Greece

Manufacturer:

Almirall Hermal GmbH, Scholtzstrasse 3, 21465 Reinbek, Germany

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Greek marketing authorization number, in the country of export: 40692/10/31-05-2011

Parallel import authorization number: 60/24

Date of leaflet approval: 12.02.2024

[Information about the trademark]
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