Verrumal

Package leaflet: Information for the patient

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.
Verrumal (Verruca Hermal)
(100 mg + 5 mg)/g, (94.8 mg + 4.74 mg)/ml, solution for skin application
Acidum salicylicum + Fluorouracilum
Verrumal and Verruca Hermal are different trade names for the same medicinal product.
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet to be able to read it again if necessary.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

1. What Verrumal is and what it is 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 pack and other information

1. What Verrumal is and what it is used for

Verrumal is a liquid preparation intended for topical application to the skin. It contains the active substances: fluorouracil and salicylic acid.
Fluorouracil is a cytostatic agent that inhibits cell growth (cytostatic factor). As a result, fluorouracil suppresses the replication of viruses causing warts, as well as the growth of warts.
Salicylic acid softens and desquamates the stratum corneum of the skin, facilitating the penetration of fluorouracil into warts.
Indications
The medicine is used in the treatment of common warts, flat warts (juvenile warts), 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 ingredients of this medicine (listed in section 6),
• during breastfeeding,
• during pregnancy or in women in whom pregnancy cannot definitely be ruled out,
• in children under 6 years of age,
• in patients with renal impairment,
• concomitantly with medicines such as brivudine, sorivudine, and other nucleoside analogues (antiviral drugs),
• Verrumal is not intended for use on large skin surfaces (the treated skin area should not exceed 25 cm² of body surface).

Verrumal must not come into contact with the eyes or mucous membranes.
Warnings and precautions
Before starting treatment with Verrumal, discuss this with your doctor or pharmacist.

• If the patient has been diagnosed with deficiency of dihydropyrimidine dehydrogenase (DPD) enzyme activity (complete DPD deficiency). It is important not to use a higher dose of Verrumal than indicated in section 3 of this leaflet.
• The medicine should not be used on particularly sensitive areas such as around the lips, nose, or mouth.
• Avoid contact of Verrumal with the skin surrounding the wart.
• In case of incorrect use (e.g. applying the liquid to the skin surrounding the wart), local burning and erosion may occur, leaving transient discoloration.
• If inflammatory reaction develops on the skin surrounding the wart, consult a doctor, as treatment should be discontinued in such cases.
• When treating a large number of warts, photosensitivity may occur.
• Verrumal should not be used earlier than 4 weeks after discontinuation of brivudine, sorivudine, and other nucleoside analogues (antiviral drugs), as these medicines may significantly increase fluorouracil plasma concentration and thereby enhance its toxicity.
• In patients treated concomitantly with phenytoin (an antiepileptic drug) and fluorouracil, plasma phenytoin levels should be monitored regularly.
• A excipient contained in the medicine – dimethyl sulfoxide – may cause skin irritation.
• If warts are located in areas of skin with a thin epidermis, the medicine should be applied less frequently and the treatment should be monitored more closely by a doctor, as salicylic acid contained in Verrumal may lead to scar formation.
• If warts are heavily keratinized, prior treatment with salicylic acid in patches may sometimes be beneficial.
• If the patient has sensory disturbances (e.g. due to diabetes), close medical supervision of treatment is necessary.
• Do not use Verrumal on bleeding skin lesions.
• After each use, the bottle must always be tightly closed, as the medicine dries out quickly when exposed to air and can no longer be used properly. Do not use the medicine if crystals appear in it.
• When applying the medicine, care should be taken to avoid staining clothing or acrylic products (e.g. acrylic bathtubs), as the medicine causes stains that cannot be removed.

WARNING: This medicine is flammable! Keep away from fire and do not use near open flames, lit cigarettes, or certain devices (e.g. hair dryers).
Children and adolescents
Verrumal is contraindicated in children under 6 years of age.
Verrumal and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.
It is essential to inform the doctor if the patient is being treated with:

• antiviral nucleoside analogue medicines such as brivudine and sorivudine (see above),
• phenytoin (an antiepileptic medicine, see above),
• methotrexate (a cytostatic medicine) and sulfonylurea derivatives (antidiabetic medicines), due to possible interactions with salicylic acid.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Use of this medicine during pregnancy and breastfeeding is contraindicated.
Do not use in women in whom pregnancy cannot definitely be ruled out.
Driving and operating machinery
Verrumal has no effect on the ability to drive or operate machinery.
Important information about certain ingredients of Verrumal
An ingredient of this medicine – dimethyl sulfoxide – may cause skin irritation.
This medicine contains 160 mg of alcohol (ethanol) in each gram of solution. The medicine may cause a burning sensation on damaged skin.

3. How to use Verrumal

This medicine should always be used as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
This medicine is intended for topical use on the skin.
Verrumal is usually applied 2 to 3 times daily to each wart.
The medicine should be applied only to the wart. Do not apply the medicine to healthy skin. The skin
surrounding the wart may be protected by applying a cream or ointment. It is recommended to wipe
the brush against the neck of the bottle before each application.
For very small warts, a toothpick or sharpened matchstick may be used instead of the brush to ensure
precise application.
Before each application of Verrumal, the residue from the previous application should be removed.
Using warm water may help in removing the residue.
Verrumal should not be applied to hairy skin areas. This may cause the hairs to stick together on the
treated skin area, making removal of the residue difficult. If treatment on hairy skin is necessary, the
area should first be shaved or other appropriate methods of hair removal should be used.
When treating periungual or subungual warts, care should be taken not to damage the nail matrix and
to prevent Verrumal from spreading to the nail bed.
The maximum treated surface area should not exceed 25 cm² of skin.
The usual duration of treatment is 6 weeks. Daily, regular use of the medicine is essential.
After the lesions have resolved, continue using the medicine for another week.
In some cases, e.g. for prominent common warts or plantar warts, removal of the remaining necrotic
tissue by a doctor may be necessary after treatment with Verrumal.
Children and adolescents
Verrumal is contraindicated in children under 6 years of age.
If the effect of the medicine seems too strong or too weak, consult a doctor or pharmacist.
Use of more than the recommended dose of Verrumal
When used correctly, i.e. according to the recommended dosage regimen, poisoning with salicylic acid
or fluorouracil is unlikely.
In case of overdose or accidental ingestion of the medicine, contact a doctor immediately.
Significantly exceeding the recommended maximum allowable treated surface area or increasing the
frequency of applications increases the risk of salicylic acid poisoning, especially in small children.
Missed dose of Verrumal
Remember to use the medicine daily and regularly. Do not use a double dose to make up for a missed
application.
Stopping treatment with Verrumal
The average duration of treatment is 6 weeks. After the lesions have resolved, continue using the
medicine for another week. Stopping treatment earlier may result in ineffective therapy. Do not
discontinue treatment without consulting a doctor.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicinal product can cause adverse reactions, although not everybody will experience them.
Adverse reactions may occur with the frequency stated below.
Very common – may occur in more than 1 in 10 people

• at the site of application: erythema (intense redness of the skin), inflammation, irritation (including burning sensation), pain, itching.

Common – may occur in not more than 1 in 10 people

• headache,
• skin desquamation (peeling),
• at the site of application: bleeding, erosion (superficial skin damage), crust formation.

Uncommon – may occur in not more than 1 in 100 people

• dry eye, eye itching, excessive tearing,
• at the site of application: dermatitis, swelling, ulceration.

Due to the strong action of the medicinal product softening the stratum corneum, whitish discoloration and skin peeling may occur, particularly around warts.
Because of the presence of salicylic acid in the product, mild irritation symptoms may occur, such as dermatitis and contact allergic reactions in the form of itching, redness, and small blisters, even outside the area where the product has contacted the skin.
If any of the adverse effects worsen or if any adverse effects not listed in this leaflet occur, inform your doctor or pharmacist.
Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse.
Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, telephone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Adverse reactions can also be reported to the marketing authorization holder or parallel importer.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Verrumal

Store in a place inaccessible and out of sight of children.
Do not store at temperatures above 25°C.
Storage below 10°C is permitted only for a short period of time.
Prolonged storage below 10°C may cause crystallization of fluorouracil.
After first opening the container (bottle) – use within 6 months.
This medicinal product is flammable! Keep away from fire and do not use near open flames,
lit cigarettes, or certain devices (e.g. hair dryers).
Do not use this medicinal product after the expiry date stated on the packaging. The expiry
date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Such measures will help
protect the environment.

6. Contents of the packaging and other information

What Verrumal contains
The active substances in this medicine are: salicylic acid and fluorouracil.
1 gram (1.05 ml) of the topical solution contains the following active substances: 100 mg (94.8 mg/ml) of salicylic acid
and 5 mg (4.74 mg/ml) of fluorouracil.
The other components (excipients) are: ethyl acetate, ethanol, dimethyl sulfoxide, copolymer of butyl methacrylate and methyl methacrylate (80:20), pyroxidine.

What Verrumal looks like and contents of the pack
Verrumal is a clear, colourless to slightly yellowish-orange topical solution.
The medicine is available in a colourless glass bottle with a cap and an applicator brush, containing 13 ml of solution, packed in a cardboard box.

For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing authorisation holder in Greece, country of export:
Galenica A.E.
Eleftherias 4
145 64 Kifisia
Greece

Manufacturer:
Almirall Hermal GmbH
Scholtzstrasse 3
21465 Reinbek
Germany

Parallel importer:
Allpharm Sp. z o.o. sp.k.
ul. M. Zdziechowskiego 11/4
02-659 Warsaw
Poland

Repackaged in:
CEFEA Sp. z o.o. Sp. Synoptis Industrial Sp. z o.o. Shiraz Productions Sp. z o.o.
spółka komandytowa ul. Forteczna 35-37 ul. Tymiankowa 24/28
ul. Działkowa 56 87-100 Toruń 95-054 Ksawerów
02-234 Warsaw
Poland

Marketing authorisation number in Greece, country of export: 40692/10/31-05-2011
Parallel import authorisation number: 261/25