Prospecto: information for the patient

Tolak 40 mg/g cream

fluorouracil

Read this prospect carefully before starting to use this medication, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you alone, and you must not give it to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1. What is Tolak and for what it is used

2.What you need to know before starting to use Tolak

3.How to use Tolak

4.Possible adverse effects

5.Storage of Tolak

6. Contents of the package and additional information

Tolak contains the active ingredient fluorouracil.

Fluorouracil belongs to a group of medicines known as antimetabolites, which inhibit cell growth (cytostatic agents).

Tolak is used to treat a skin disease called actinic keratosis (sun-damaged skin) of grade I and II on the face, ears, and/or scalp in adults.

Information on how Tolak works

When using Tolak, it is likely that the treated skin area will become red.

Tolak destroys cancerous and precancerous skin cells, but has a lesser effect on normal cells.

Tolak also treats skin abnormalities that are not visible to the naked eye, so areas with these abnormalities may become red and inflamed.

The process will likely continue with inflammation/swelling, possibly some discomfort, skin erosion, and finally, healing. This is the expected normal response to treatment and indicates that Tolak is working.

In some cases, the response is more severe (see section 4, "Possible side effects"). If your skin worsens significantly, if you feel pain, or if you are concerned about the reaction, consult your doctor. The doctor may prescribe another cream to alleviate discomfort.

Skin reactions are transient and disappear within 2 to 4 weeks of completing treatment. Therefore, after completing treatment, your skin may take 4 weeks to heal.

Do Not Use Tolak

• If you are allergic (hypersensitive) to fluorouracil or any of the other components of this medication (listed in section 6)
• If you are allergic (hypersensitive) to peanuts or soy
• If you are pregnant
• If you are breastfeeding
• If you are using any of the medications known as nucleoside antivirals (e.g., brivudine and sorivudine). These medications are normally used to treat chickenpox or shingles.

Warnings and Precautions

Consult your doctor or pharmacist before starting to use Tolak.

• Do not apply Tolak directly to the eyes, nose, mouth, or other mucous membranes, as it may cause irritation, local inflammation, and ulceration.
• Do not apply Tolak to open wounds or damaged skin.
• It is expected that the treated skin area will experience redness, possibly followed by inflammation/swelling, possibly some discomfort, skin erosion, and finally, healing. This is the normal expected response to treatment and indicates that Tolak is working. Consult your doctor if the skin worsens, if you feel pain, or if you are concerned about the reaction. Your doctor may prescribe another cream to alleviate discomfort.
• Do not cover the area where you have applied Tolak with bandages or dressings, as it may increase the inflammatory reaction of the skin.
• To avoid transferring the medication to the eyes or contact lenses and the surrounding eye area during and after application, you must wash your hands thoroughly after applying Tolak.
• If an accidental exposure occurs, you must rinse your eyes with plenty of water.
• Allergic reactions (contact eczema) may occur. Consult your doctor if you notice intense itching or skin redness in areas other than the treated lesions.
• You must avoid exposure to UV radiation (both natural sunlight and tanning beds).
• If you know that you do not have any dihydropyrimidine dehydrogenase (DPD) enzyme activity (complete DPD deficiency) or reduced activity (partial DPD deficiency).

Tolak may cause severe adverse effects in people who do not have sufficient dihydropyrimidine dehydrogenase (DPD) enzyme activity. Stop using Tolak immediately if you experience any of the following symptoms: mouth ulceration (mucositis), abdominal pain, bloody diarrhea, vomiting, fever, and chills.

Children and Adolescents

Tolak is not indicated for use in children and adolescents under 18 years old.

Other Medications and Tolak

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. Especially if you are using medications to treat chickenpox or shingles (brivudine and sorivudine) or have used them in the last 4 weeks. These medications may increase the risk of unwanted effects with Tolak. Therefore, they should not be used together with Tolak.

Pregnancy, Breastfeeding, and Fertility

Tolak should not be used during pregnancy.

If you become pregnant during treatment, you must stop using Tolak, and immediately consult your doctor for advice on the risk to the baby.

Women of childbearing age taking Tolak should use an effective contraceptive method during treatment and for 6 months after the last dose of Tolak. Consult your doctor if you need advice on contraception.

Men taking Tolak should use effective contraceptive methods and not conceive a child during treatment and for 3 months after the last dose of Tolak.

The passage of Tolak into breast milk is unknown. Tolak should not be used during breastfeeding.If its use is absolutely necessary during this period, breastfeeding must be interrupted.

The use of Tolak may affect male and female fertility. The use of Tolak is not recommended in men and women trying to conceive.

Driving and Operating Machines

It is unlikely that treatment will affect your ability to drive and operate machines.

Tolak Contains:

• Butilhydroxytoluene (E 321):

May cause local skin reactions (such as contact dermatitis) or irritation of the eyes and mucous membranes.

• Cetyl alcohol and stearic alcohol

May cause local skin reactions (such as contact dermatitis).

• Parahydroxybenzoic acid methyl ester (E 218) and parahydroxybenzoic acid propyl ester

May cause allergic reactions (possibly delayed).

• Refined peanut oil (peanut oil)

Should not be used in case of allergy to peanuts or soy.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

How to apply Tolak

Apply Tolak once a day covering the skin areas that need to be treated, for 4 weeks, in the following way:

• Clean, clear, and gently dry the skin areas that need to be treated.
• Apply a thin layer of Tolak to the skin areas that need to be treated.
• Give a gentle massage to allow Tolak to penetrate into the skin.
• Avoid contact with other body areas, as well as the transfer of Tolak from your body to another person.
• Wash your hands thoroughly after applying Tolak.

If you use moreTolakthan you should

If Tolak is applied more frequently than once a day, it is more likely that you will experience skin reactions and that these will be more severe.

If you or a child accidentally ingest Tolak, inform your doctor or go to the emergency room immediately.

In case of overdose, consult your doctor or pharmacist or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to useTolak

Do not use a double dose to compensate for the missed doses. Continue treatment as indicated by your doctor or as described in this prospectus.

If you interrupt the treatment withTolak

Contact your doctor before interrupting treatment unless you present any of these symptoms: mouth ulceration, abdominal pain, bloody diarrhea, vomiting, fever, and chills. In that case, stop using Tolak and inform your doctor immediately (see section 2).

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

Frequent Adverse Effects (may affect up to 1 in 10 patients)

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

Less Frequent Adverse Effects (may affect up to 1 in 100 patients)

-Impetigo (bacterial skin infection)

-Throat pain (pharyngitis)

-Insomnia

-Nasal discomfort

-Lip blister

-Nausea

-Swelling around the eyes (edema)

-Excessive tearing (lacrimation)

-Redness

-Reactions at the application site: bleeding, erosion, eczema, discomfort, dryness, burning/tingling, photosensitivity reaction (increased skin reactivity to sunlight).

The frequency of the following adverse effects is unknown (cannot be estimated from available data)

-Contact dermatitis (allergic reaction)

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not store Tolak at a temperature above 25º C.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not use Tolak after 4 weeks following the first opening of the tube (piercing it with the cap).

Medicines should not be disposed of through drains or in the trash.Deposit the containers and medicines you no longer need at the SIGRE collection pointof the pharmacy.In case of doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Tolak

- The active ingredient is: fluorouracil

- The other components are: stearoyl macrogolglycerides, 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 peanut oil (peanut oil), sodium hydroxide (E 524), stearic acid, and stearyl alcohol.

Appearance of the product and contents of the packaging

White or off-white cream in a 20g or 40g tube

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization

PIERRE FABRE IBÉRICA, S.A.

C/ Ramón Trias Fargas, 7-11

08005 Barcelona - Spain

Responsible for manufacturing

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 with the following names:

- Tolak: Austria, Czech Republic, Denmark, France, Germany, Greece, Netherlands, Norway, Poland, Slovak Republic, Spain, Sweden, United Kingdom

- Efflurak: Belgium, Luxembourg, Portugal.

- Tolerak: Finland, Italy

Revision date of this leaflet: April 2024

Detailed and updated information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/