TOLAK 40 mg/g CREAM

Introduction

Package Leaflet: Information for the Patient

Tolak 40 mg/g Cream

fluorouracil

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet

1. What is Tolak and what is it used for
2. What you need to know before you use Tolak
3. How to use Tolak
4. Possible side effects
5. Storage of Tolak
6. Contents of the pack and other information

1. What is Tolak and what is it used for

Tolak contains the active substance fluorouracil.

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

Tolak is used to treat a skin condition 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 anomalies that are not visible to the naked eye, so areas with such anomalies may become red and inflamed.

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

Occasionally 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. Your doctor may prescribe another cream to alleviate the discomfort.

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

2. What you need to know before you use Tolak

Do not use Tolak

• If you are allergic (hypersensitive) to fluorouracil or any of the other ingredients of this medicine (listed in section 6)
• If you are allergic (hypersensitive) to peanuts or soya
• If you are pregnant
• If you are breast-feeding
• If you are using any of the medicines known as antiviral nucleosides (e.g. brivudine and sorivudine). These are medicines 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 become red, probably followed by inflammation/swelling, possibly some discomfort, skin erosion, and finally scarring. This is the normal expected response to treatment and indicates that Tolak is working. Consult your doctor if your skin worsens significantly, if you feel pain, or if you are concerned about the reaction. Your doctor may prescribe another cream to alleviate the discomfort.
• Do not cover the area where you have applied Tolak with bandages or dressings, as this may increase the inflammatory skin reaction.
• To avoid transferring the medicine to the eyes or contact lenses and the area around the eyes during and after application, you should wash your hands well after applying Tolak.
• If accidental exposure occurs, you should rinse your eyes with plenty of water.
• Allergic reactions (contact eczema) may occur. Consult your doctor if you notice intense itching or redness of the skin in areas other than the treated lesions.
• You should avoid exposure to UV radiation (both natural sunlight and tanning beds).
• If you know you have no dihydropyrimidine dehydrogenase (DPD) enzyme activity (complete DPD deficiency) or reduced activity (partial DPD deficiency)...

Tolak may cause severe side effects in people who do not have sufficient dihydropyrimidine dehydrogenase (DPD) enzyme. Stop using Tolak immediately if you experience any of these symptoms: mouth ulcers (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 of age.

Other medicines and Tolak

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. In particular, if you are using medicines to treat chickenpox or shingles (brivudine and sorivudine) or have used them in the last 4 weeks. These medicines may increase the chances of unwanted effects with Tolak. Therefore, they should not be used with Tolak.

Pregnancy, breast-feeding, and fertility

Tolak should not be used during pregnancy.

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

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

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

It is not known if Tolak passes into breast milk. Tolak should not be used during breast-feeding. If its use is absolutely necessary during this period, breast-feeding should be discontinued.

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

Driving and using machines

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

Tolak contains:

• Butylhydroxytoluene (E 321):

May cause local skin reactions (such as contact dermatitis) or eye and mucous membrane irritation.

• Cetyl alcohol and stearyl alcohol

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

• Methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate

May cause allergic reactions (possibly delayed).

• Refined peanut oil

Should not be used in case of peanut or soya allergy.

3. How to use Tolak

Follow exactly the instructions for administration of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

How to apply Tolak

Apply Tolak once a day to the areas of skin that need to be treated, for 4 weeks, as follows:

• Wash, rinse, and gently dry the areas to be treated.
• Apply a thin layer of Tolak to the areas to be treated.
• Gently massage to help Tolak penetrate the skin.
• Avoid contact with other areas of the body, as well as transferring Tolak from your body to another person's.
• Wash your hands well after applying Tolak.

If you use more Tolak than you should

If you apply Tolak more frequently than once a day, you are more likely to experience skin reactions and they may be more severe.

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

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

If you forget to use Tolak

Do not use a double dose to make up for forgotten doses. Continue treatment as your doctor has indicated or as described in this leaflet.

If you stop using Tolak

Consult your doctor before stopping treatment unless you experience any of the following symptoms: mouth ulcers, 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 further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine 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)
• Eye irritation

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

• Impetigo (bacterial skin infection)
• Sore throat (pharyngitis)
• Insomnia
• Nasal discomfort
• Cold sore
• Nausea
• Swelling around the eyes (edema)
• Watery eyes (lacrimation)
• Redness
• Skin reactions at the application site: bleeding, erosion, eczema, discomfort, dryness, burning/tingling, photosensitivity reaction (increased skin reactivity to sunlight)

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

• Allergic reactions (contact eczema)

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Tolak

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

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

Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date is the last day of the month shown.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Tolak

• The active substance is: fluorouracil
• The other ingredients are: stearyl macroglycerides, 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, sodium hydroxide (E 524), stearic acid, and stearyl alcohol.

Appearance and packaging

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

Not all pack sizes may be marketed.

Marketing authorisation holder

PIERRE FABRE IBÉRICA, S.A.

C/ Ramón Trias Fargas, 7-11

08005 Barcelona - Spain

Manufacturer

PIERRE FABRE MEDICAMENT PRODUCTION,

Parc Industriel de la Chartreuse

81100 Castres France.

This medicine is authorised 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
• Efflurak: Belgium, Luxembourg, Portugal.
• Tolerak: Finland, Italy

Date of last revision of this leaflet: April 2024

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/