Tolak

Leaflet accompanying the packaging: patient information

Tolak, 40 mg/g, cream

Fluorouracil
You should carefully read the contents of the leaflet before using the medicine, as it contains
important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Tolak and what is it used for

Tolak is a medicine that contains fluorouracil as the active substance.
Fluorouracil belongs to a group of medicines known as antimetabolites, which inhibit cell growth
(cytostatics).
Tolak is used to treat a skin disease called solar keratosis (skin damaged by sunlight) I and II degree on the face, ears and/or skin of the head in adults.

How Tolak works

During the use of Tolak, redness of the treated skin area may occur.
Tolak destroys cancerous and precancerous skin cells, while having a smaller effect on healthy cells.
Tolak is also used to treat skin changes that were not previously visible to the naked eye, which may become red or inflamed.
The next possible stages of the medicine's action are inflammation and/or swelling, possible discomfort, skin erosion, and finally healing. This is an expected, normal reaction to treatment, which shows that Tolak is working.
It is possible for a more severe reaction to treatment to occur (see section 4 "Possible side effects").
If the skin condition worsens significantly, the patient experiences pain or is concerned, they should consult a doctor. The doctor may prescribe another cream to alleviate the discomfort.
The skin reaction to treatment is temporary and subsides within 2-4 weeks after its completion. After stopping treatment, it may take about 4 weeks for the skin healing process to complete.

2. Important information before using Tolak

When not to use Tolak:

• If the patient is allergic (hypersensitive) to fluorouracil or any of the other ingredients of this medicine (listed in section 6)
• If the patient is allergic (hypersensitive) to peanuts or soy
• In pregnant women
• In breastfeeding women
• In patients using antiviral medicines from the nucleoside group (e.g. brivudine and sorivudine). These are medicines usually used to treat chickenpox or shingles.

Warnings and precautions

Before starting to use Tolak, you should discuss it with your doctor or pharmacist.

• Tolak should not be applied directly to the eyes, nose, mouth, or other mucous membranes due to the possibility of irritation, local inflammation, or ulceration.
• Tolak should not be used on open wounds or damaged skin.
• During the use of the medicine, redness of the treated skin area may occur, followed by a possible inflammatory reaction and/or swelling, discomfort, skin erosion, and finally healing. This is an expected, normal reaction to treatment, which shows that Tolak is working. If the skin condition worsens significantly, the patient experiences pain or is concerned, they should consult a doctor. The doctor may prescribe another cream to alleviate the discomfort.
• Tolak should not be used under bandages or dressings, as this may exacerbate skin inflammation.
• To avoid transferring the medicine to the eyes and/or contact lenses and the area around the eyes during application or after application, you should wash your hands thoroughly after using Tolak.
• In case of accidental contact of the medicine with the eyes, they should be rinsed with a large amount of water.
• It is possible for allergic reactions (contact dermatitis) to occur. If severe itching or redness of the skin occurs outside the treated areas, you should consult a doctor.
• You should avoid exposure to ultraviolet radiation (e.g. natural sunlight, solarium).
• If the patient knows that they have reduced or absent activity of the enzyme dihydropyrimidine dehydrogenase (DPD) (partial or complete DPD deficiency). In people with DPD deficiency, the use of Tolak may cause severe side effects. You should stop using Tolak and immediately consult a doctor if any of the following symptoms occur: oral ulcers (stomatitis), abdominal pain, bloody diarrhea, vomiting, fever, and chills.

Children and adolescents

Tolak is not intended for use in children and adolescents under the age of 18.

Tolak and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. You should especially inform your doctor if you are using medicines for the treatment of chickenpox or shingles (brivudine and sorivudine) currently or in the last 4 weeks. The use of these medicines may increase the risk of side effects during the use of Tolak. Therefore, you should not use these medicines at the same time as Tolak.

Pregnancy, breastfeeding, and fertility

Tolak should not be used during pregnancy.
If a patient becomes pregnant during treatment, the use of Tolak should be discontinued, and the patient should immediately consult a doctor to obtain information about the risk to the child.
Women of childbearing potential must use effective contraception during treatment with Tolak and for 6 months after the last dose of Tolak. If necessary, you should consult a doctor about contraception.
Men must use effective contraception and avoid fathering a child during treatment with Tolak and for 3 months after the last dose of Tolak.
It is not known whether Tolak passes into breast milk. Tolak should not be used during breastfeeding. If the use of Tolak is absolutely necessary during breastfeeding, breastfeeding should be discontinued.
The use of Tolak may affect fertility in women and men. Tolak should not be used in women and men trying to conceive.

Driving and using machines

It is unlikely that treatment will have any effect on the ability to drive and use machines.

What Tolak contains

• Butylhydroxytoluene (E 321): May cause local skin reactions (e.g. contact dermatitis) or eye and mucous membrane irritation.
• Cetyl alcohol and stearyl alcohol: May cause local skin reactions (e.g. contact dermatitis).
• Methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate: These substances may cause allergic reactions (which may be delayed).
• Refined arachidic oil (peanut oil): Do not use the medicine in patients with an allergy to peanuts or soy.

3. How to use Tolak

This medicine should always be used exactly as your doctor has told you. If you are not sure, you should ask your doctor or pharmacist.

How to use Tolak

Tolak should be applied once a day to the treated skin areas for a period of 4 weeks in the following way:

• Wash, rinse, and gently dry the skin areas to be treated.
• Apply a thin layer of Tolak to the skin areas to be treated.
• Gently and evenly massage Tolak into the skin.
• You should avoid contact of the medicine with other parts of the body, as well as transferring it from the patient's skin to the skin of other people.
• After applying Tolak, you should wash your hands thoroughly.

Using more Tolak than recommended

If you use Tolak more often than once a day, the risk of skin reaction and its severe course increases.
In case of accidental ingestion of Tolak by a patient or child, you should immediately consult a doctor or go to the nearest hospital emergency department.

Missing a dose of Tolak

You should not use a double dose to make up for a missed dose. You should continue treatment as recommended by your doctor or according to the information contained in this leaflet.

Stopping the use of Tolak

Before stopping the use of Tolak, you should consult a doctor, unless you experience any of the following symptoms: oral ulcers, abdominal pain, bloody diarrhea, vomiting, fever, and chills. In such a case, you should stop using Tolak and immediately consult a doctor (see section 2, "Warnings and precautions").
If you have any further doubts about the use of this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Tolak can cause side effects, although not everybody gets them.

Common side effects (may affect up to 1 in 10 people):

• Skin reactions at the application site [irritation, pain, reaction, redness, itching, inflammation, swelling (edema)],
• Eye irritation.

Uncommon side effects (may affect up to 1 in 100 people)

• Impetigo (bacterial skin infection),
• Sore throat (pharyngitis),
• Insomnia,
• Discomfort in the nose,
• Cold sores on the lip surface,
• Nausea,
• Swelling around the eyes,
• Increased tearing of the eyes,
• Redness,
• Skin reactions at the application site: bleeding, erosion, rash, discomfort, dryness, burning, and/or tingling, hypersensitivity reaction to light (increased skin sensitivity to sunlight).

The frequency of the following side effects is not known (cannot be estimated from the available data):

• Allergic reactions (contact dermatitis).

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should 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:
Jerozolimskie Avenue 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 Tolak

The medicine should be stored out of the sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the carton after: EXP.
The expiry date stated is the last day of the month.
Do not use Tolak after 4 weeks from the first opening of the tube (by piercing the seal with the cap).
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Tolak contains

• The active substance is:fluorouracil
• The other ingredients are:macrogol stearate, butylhydroxytoluene (E 321), cetyl alcohol, citric acid (E 330), glycerol (E 422), isopropyl myristate, methyl gluceth-10, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate, purified water, refined arachidic oil (peanut oil), sodium hydroxide (E 524), stearic acid, and stearyl alcohol.

What Tolak looks like and contents of the pack

White or off-white cream in a 20 g or 40 g tube.
Not all pack sizes may be marketed.

Marketing authorization holder

Pierre Fabre Medicament
Les Cauquillous
81500 Lavaur
France

Importer:

PIERRE FABRE MEDICAMENT PRODUCTION
Parc Industriel de la Chartreuse
81100 Castres
France

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

• Tolak:Austria, Czech Republic, Denmark, France, Germany, Greece, Netherlands, Norway, Poland, Slovakia, Spain, Sweden, United Kingdom
• Tolerak:Italy, Finland
• Efflurak:Belgium, Luxembourg, Portugal

In order to obtain more detailed information, you should contact the representative of the marketing authorization holder:
Pierre Fabre Dermo-Cosmetique Polska Sp. z o.o.
Belwederska 20/22
00-762 Warsaw
phone: 22 559 63 60

Date of last revision of the leaflet: April 2024

Other sources of information

Detailed information about this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products.