Package leaflet: information for the user

Warning! Keep the leaflet. 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 cutaneous use
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, as you may need to read it again.
If you have any questions, please 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 other people, 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:

What Verrumal is and what it is used for
Important information before using Verrumal
How to use Verrumal
Possible side effects
How to store Verrumal
Contents of the pack and other information

1. What Verrumal is and what it is used for

Verrumal is a solution intended for topical application to the skin. It contains the active substances: fluorouracil and
salicylic acid.
Fluorouracil is a cytostatic agent which inhibits cell growth (cytostatic agent).
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 the warts.
Indications
The product is indicated for 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 medicines),

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

Contact of Verrumal with eyes or mucous membranes must be avoided.
Warnings and precautions
Before starting treatment with Verrumal, discuss this with your doctor or pharmacist.

If the patient has been diagnosed with deficiency of the enzyme dihydropyrimidine dehydrogenase (DPD) (complete DPD deficiency). It is important not to use a higher dose of Verrumal than stated in section 3 of this leaflet.
The medicine should not be used on particularly sensitive areas, such as around the mouth, nose, and lips.
Avoid contact of Verrumal with the skin surrounding the wart.
Improper use of the medicine (e.g. applying the solution to the skin surrounding the wart) may cause local burning and erosion, leading to transient discoloration.
If inflammatory reaction occurs on the skin surrounding the wart, contact your doctor, as treatment should be discontinued in such cases.
When treating a very large number of warts, photosensitivity may occur.
Verrumal may be used no earlier than 4 weeks after discontinuation of brivudine, sorivudine, and other nucleoside analogues (antiviral medicines), as these medicines may significantly increase fluorouracil plasma concentration and thereby enhance its toxicity.
In patients treated concomitantly with phenytoin (an antiepileptic medicine) and fluorouracil, plasma phenytoin concentration should be monitored regularly.
The excipient contained in the medicine – dimethyl sulfoxide – may cause skin irritation.
If warts are located in areas of skin with a thin epidermal layer, the medicine should be applied less frequently and treatment should be monitored more closely by a doctor, as salicylic acid contained in Verrumal may cause scarring.
If warts are heavily keratinized, preliminary treatment with salicylic acid in plaster form may sometimes be beneficial.
If the patient has sensory disorders (e.g. due to diabetes), treatment must be closely monitored by a doctor.
Verrumal should not be used in case of bleeding skin lesions.
After each use, the bottle must always be tightly closed, as the medicine dries out quickly when the bottle is open and cannot then be used properly. The medicine should not be used 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: The medicine is flammable! Keep away from fire and do not use near open flame, lit cigarette, or certain devices (e.g. hair dryers).
Children and adolescents
Verrumal is contraindicated in children under 6 years of age.
Verrumal with 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.
You must definitely inform your doctor if you are being treated with:

antiviral nucleoside analogue medicines such as brivudine and sorivudine (see above),

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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 her 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 some ingredients of Verrumal
The substance contained in the medicine – dimethyl sulfoxide – may cause skin irritation.
This medicine contains 160 mg of alcohol (ethanol) in each gram of solution. The medicine may cause stinging of damaged skin.

3. How to use Verrumal

This medicine should always be used exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
This medicine is 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 it to healthy skin. The skin surrounding
the wart can be protected by applying a cream or ointment. It is recommended to wipe the brush
on the neck of the bottle before each application.
For very small warts, a toothpick or a sharpened matchstick may be used instead of the brush to ensure
accurate application.
Before each application of Verrumal, the residue from the previous application should be removed.
Warm water may help in removing the layer.
Do not apply Verrumal to hairy skin. This may cause the hairs on the treated area to stick together,
making removal of the layer difficult. If application on hairy skin is necessary, the area should first
be shaved or other appropriate hair removal methods used.
When treating periungual or subungual warts, care should be taken not to damage the nail matrix
and to prevent Verrumal from entering the nail bed.
The maximum treated area should not exceed 25 cm² of skin surface.
The usual duration of treatment is 6 weeks. Daily, regular use of the medicine is essential.
After the lesions have resolved, continue treatment for another 1 week.
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In some cases, e.g. in the case of prominent common warts or plantar warts, removal of the remaining
necrotic tissue by a doctor may be indicated after treatment with Verrumal.
Children and adolescents
Verrumal is contraindicated in children under 6 years of age.
If you feel the effect of the medicine is too strong or too weak, consult your 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, seek immediate medical advice from a doctor.
Significantly exceeding the recommended maximum allowable treated surface area or increasing
the frequency of application increases the risk of salicylic acid poisoning, especially in young 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 Verrumal treatment
The average duration of treatment is 6 weeks. After the lesions have resolved, continue treatment
for another 1 week. Stopping treatment earlier may result in ineffective therapy.
Do not stop treatment without consulting your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

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

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

Common – may affect up to 1 in 10 people

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

Uncommon – may affect up to 1 in 100 people

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

Due to the strong keratolytic action of the medicine softening the stratum corneum, whitish discolorations and skin peeling may occur, particularly around the warts.
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Due to the presence of salicylic acid in the medicine, mild irritation symptoms may occur, such as skin inflammation and contact allergic reactions, manifesting as itching, redness, and small blisters, even outside the area where the medicine contacts the skin.
If any of the adverse reactions worsen or if any adverse reactions 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 Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Verrumal

Keep out of sight and reach of children.
Do not store above 25°C.
Store below 10°C only for a short period of time.
Prolonged storage below 10°C may cause crystallization of fluorouracil.
After first opening the package (bottle) – use within 6 months.
The medicine 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 medicine 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 in use. This will help protect the environment.

6. Contents of the packaging and other information

What Verrumal contains
The active substances in Verrumal are: salicylic acid and fluorouracil.
1 g of solution contains the active substances: 100 mg of salicylic acid and 5 mg of fluorouracil.
The other components (excipients) are: ethyl acetate, ethanol, dimethyl sulfoxide,
butyl methacrylate and methyl methacrylate copolymer (80:20), piroxilin.

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

For more detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.

Marketing Authorisation 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, Poland

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

Marketing Authorisation number in Greece, the country of export: 40692/10/31-05-2011
Parallel Import Licence number: 60/24
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