Verrucutan

Package Leaflet: Information for the User

Verrucutan, (5 mg + 100 mg)/g, Cutaneous Solution

Fluorouracil + Salicylic Acid

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• Ask your doctor or pharmacist if you have any further questions.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

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

1. What is Verrucutan and what is it used for

Verrucutan is a medicine for warts.
Verrucutan is used for common warts, plantar warts (verrucae)
and flat warts (juvenile flat warts) on hands and feet.

2. Important information before using Verrucutan

When not to 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 cannot rule out that you are pregnant,
in infants,
if you have kidney failure,
if you are using certain antiviral medicines for the treatment of chickenpox or shingles (Herpes zoster treatment).
Do not use Verrucutan at the same time as treatment with brivudine, sorivudine or similar groups of medicines used to treat shingles. Treatment can be started 4 weeks after discontinuation of these medicines. Concomitant use of one of the active substances of the medicine, fluorouracil, with brivudine, sorivudine and their derivatives may lead to a significant increase in the side effects of Verrucutan. Fluorouracil treatment should not be started until at least 4 weeks after the end of shingles treatment with brivudine or sorivudine.
If you have recently been treated for shingles, inform your doctor.
Verrucutan is not intended for use on large areas of skin (larger than 25 cm) and should not come into contact with the eyes and mucous membranes.

Warnings and precautions

Before starting treatment with Verrucutan, discuss it with your doctor or pharmacist if you have been diagnosed with a lack of dihydropyrimidine dehydrogenase (DPD) enzyme activity (complete DPD deficiency).
Caution should be exercised when taking phenytoin used to treat epileptic seizures. Verrucutan may increase the concentration of phenytoin in the blood. For this reason, during treatment with Verrucutan, the concentration of phenytoin in the blood should be regularly monitored.
If the warts are located in an area of skin with a thin layer of epidermis, the medicine should be applied less frequently and the doctor should monitor the treatment more closely, as the salicylic acid in Verrucutan may cause scarring.
If you have problems with touch, pain and temperature sensation (sensory disturbances, e.g. due to diabetes) close monitoring of the treatment by the doctor is necessary.
When applying the medicine, be careful not to stain materials or acrylic products (e.g. acrylic bathtubs), as the medicine can cause stains that cannot be removed.
Verrucutan is flammable until a film forms after application.
Keep it away from fire or flames.
Verrucutan should not be used on bleeding skin lesions.

Children

Verrucutan should not be used in infants. In children, the risk of overdose is higher than in adults, so - especially in young children - the recommended surface area and frequency of treatment should not be exceeded.

Verrucutan and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken or might take.
This is especially important because if several medicines are taken at the same time, the effect of individual medicines may be enhanced or weakened.
Do not use Verrucutan if you are taking or have taken certain medicines for the treatment of viral diseases, such as chickenpox or shingles (brivudine, sorivudine or their derivatives), within the last 4 weeks.
Particular caution should be exercised if you are taking certain antiepileptic medicines (phenytoin). Based on the systemic use of fluorouracil in cancer treatment, it is known that concomitant use with phenytoin may lead to increased phenytoin levels.
Due to the fact that salicylic acid can be absorbed, interactions between salicylic acid and methotrexate (a medicine used to treat certain rheumatic diseases, cancers or severe psoriasis) and sulfonylurea derivatives (found in some medicines that lower blood sugar levels - antidiabetic medicines) 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 taking this medicine.
Use during pregnancy and breastfeeding is contraindicated.
Do not use in women who are definitely not pregnant.

Driving and using machines

No special precautions are necessary.

Verrucutan contains dimethyl sulfoxide and alcohol (ethanol)

Dimethyl sulfoxide may cause skin irritation.
This medicine contains 171.5 mg/g of alcohol (ethanol). It may cause irritation to damaged skin.

3. How to use Verrucutan

This medicine should always be used as directed by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist.

Dosage

Unless your doctor has told you otherwise, Verrucutan is applied 2 to 3 times a day to each wart.

Method of administration

For cutaneous use.
The medicine should only be applied to the wart. Do not apply the medicine to healthy skin. The skin surrounding the wart can be protected from the medicine by applying a paste or ointment. If necessary, your doctor or pharmacist may recommend a suitable medicine. It is recommended to clean the shoulder of the bottle before use. For very small warts, a toothpick can be used instead of a spatula to apply the medicine accurately. Before each application of Verrucutan, remove any remaining coating from the previous application by rubbing it off.
For periungual or subungual warts, be careful not to damage the nail matrix and not to let Verrucutan penetrate into the nail bed.
Verrucutan is not intended for use on large areas of skin. The maximum treatment area should not exceed 25 cm of skin surface.
Regular medical check-ups are recommended during the treatment period. Experience has shown that in many cases, e.g. with strongly protruding common warts or warts on the feet, after treatment with Verrucutan, it is recommended to remove the remaining dead tissue by a doctor.

Duration of treatment

The usual treatment period is 6 weeks.
After the lesions have disappeared, the medicine should be used for another week.
If you feel that the effect of the medicine is too strong or too weak, consult your doctor or pharmacist.

Using more Verrucutan than prescribed

If you use more medicine than prescribed, contact your doctor.

Missing a dose of Verrucutan

Do not take a double dose to make up for a forgotten dose. Continue using the medicine as directed by your doctor or according to the information in this package leaflet.

Stopping treatment with Verrucutan

If you stop using Verrucutan, contact your doctor.
If you have any further questions about using the medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Verrucutan can cause side effects, although not everybody gets them.
Very common(may affect more than 1 in 10 people):
at the application site: redness, inflammation, irritation, burning, pain, itching.
Common(may affect up to 1 in 10 people):
at the application site: bleeding, scabbing, discharge, erosion (superficial skin damage).
Headache may occur.
Uncommon(may affect up to 1 in 100 people):
at the application site: skin inflammation, swelling, ulceration. Dry eye, eye itching, increased tearing may occur.
Rare(may affect up to 1 in 1,000 people):
Severe burning sensation may occur, in which case treatment should be discontinued.
Due to the salicylic acid content in the product, mild irritation symptoms, such as skin inflammation and hypersensitivity reactions (contact allergic reactions), may occur.
Irritation symptoms may also include: itching, redness and blisters outside the area of contact with the skin.
In the area of the warts, white discoloration and skin peeling may occur.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Verrucutan

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "EXP".
The expiry date refers to the last day of the month.
Do not store above 30°C.
Do not store in the refrigerator or freeze.
Shelf life after first opening of the bottle: 6 months.
After each use, the bottle with the medicine should be tightly closed, as the medicine dries out quickly when the bottle is open, which makes it impossible to use it correctly. If the medicine has dried out, it cannot be used. Do not use Verrucutan if crystals have formed in it.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.
Note: The medicine is flammable. Keep it away from fire or flames.

6. Contents of the package and other information

What Verrucutan contains

The active substances of the medicine 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, butyl methacrylate and methyl methacrylate copolymer (80:20), pyroxylin.

What Verrucutan looks like and contents of the package

Verrucutan is a clear, colorless to slightly orange solution for cutaneous use.
Type of packaging: brown glass bottle with a child-resistant polyethylene cap, with a polyethylene spatula, in a cardboard box.
Package size: 13 ml (12.3 g) and 14 ml (13.2 g).
Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

SUN-FARM Sp. z o.o.
ul. Dolna 21
05-092 Łomianki

Manufacturer:

SUN-FARM Sp. z o.o.
ul. Dolna 21
05-092 Łomianki
mibe GmbH Arzneimittel
Münchener Straße 15
06796 Brehna
Germany

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Croatia
Verrucutan 5 mg/g + 100 mg/g solution for the skin
Germany
Verrucutan 5 mg/g + 100 mg/g solution for cutaneous use
Poland
Verrucutan
Date of last revision of the package leaflet:05.2022