Tolerak

Package leaflet: Information for the patient

Tolerak 40 mg/g cream

fluorouracil
Read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If any adverse reaction occurs, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Tolerak is and what it is used for

Tolerak contains the active substance fluorouracil.
Fluorouracil belongs to a group of medicines known as antimetabolites, which inhibit cell growth (cytostatic agents).
Tolerak 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 Tolerak works
When you use Tolerak, the skin area being treated is likely to become red.
Tolerak destroys cancerous and pre-cancerous skin cells, while having less effect on normal cells.
Tolerak will also treat skin abnormalities that were previously not visible to the naked eye, and these areas may become red and inflamed.
This is usually followed by inflammation/swelling, possibly some discomfort, skin erosion, and finally healing. This is the expected normal response to treatment and shows that Tolerak is working.
Sometimes the reaction may be more severe (see section 4 “Possible side effects”). If your skin worsens significantly, becomes painful, or if you are concerned, speak to your doctor. Your doctor may prescribe another cream to relieve any discomfort.
Skin reactions are transient and resolve within 2–4 weeks after the end of treatment. Therefore, after stopping treatment, it may take approximately 4 weeks for the skin to heal.

2. What you need to know before using Tolerak

Do not use Tolerak:

• if you are allergic (hypersensitive) to fluorouracil or to any of the other ingredients of this medicine (listed in section 6)
• if you are allergic (hypersensitive) to peanuts or soya
• during pregnancy
• if you are breastfeeding
• if you are taking antiviral nucleoside medicines (e.g. brivudine and sorivudine). These medicines are generally used to treat chickenpox or shingles.

Warnings and precautions
Talk to your doctor or pharmacist before using Tolerak.

• Do not apply Tolerak directly into the eyes, nose, mouth, or on other mucous membranes, as irritation, local inflammation, and ulceration may occur.
• Do not apply Tolerak on open wounds or damaged skin.
• The treated skin area is likely to become red, and may subsequently develop inflammation/swelling, some discomfort, skin erosion, and eventually healing. This is the expected normal response to treatment and shows that Tolerak is working. Speak with your doctor if the skin condition worsens significantly, if you experience pain, or if you are concerned. Your doctor may prescribe another cream to relieve any discomfort.
• Do not apply Tolerak under bandages or occlusive dressings, as this may increase skin inflammatory reactions.
• To avoid contact of the medicine with the eyes and/or contact lenses and the area around the eyes during and after application, it is essential to wash your hands thoroughly after applying Tolerak.
• In case of accidental exposure, rinse the eyes thoroughly with water.
• Allergic reactions (contact eczema) may occur. Inform your doctor if you experience severe itching or if redness develops beyond the treated lesion areas.
• Exposure to UV radiation (e.g. natural sunlight, sunlamps) must be avoided.
• If you know you have reduced or absent activity of the enzyme dihydropyrimidine dehydrogenase (DPD) (partial deficiency or complete absence of DPD).
• Tolerak may cause severe side effects in people who have a deficiency of the enzyme dihydropyrimidine dehydrogenase (DPD). Stop using Tolerak and contact a doctor immediately if you experience any of the following symptoms: mouth ulceration (mucositis), abdominal pain, bloody diarrhoea, vomiting, fever, and chills.

Children and adolescents
Tolerak is not indicated for use in children and adolescents under 18 years of age.
Other medicines and Tolerak
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. In particular, inform your doctor if you are using medicines for the treatment of chickenpox or shingles (brivudine and sorivudine) or if you have used them within the last 4 weeks. These medicines may increase the likelihood of adverse effects when using Tolerak. Therefore, these medicines must not be used during treatment with Tolerak.
Pregnancy, breastfeeding and fertility
Tolerak must not be used during pregnancy.
If you become pregnant during treatment, treatment with Tolerak must be stopped. Contact your doctor immediately for information on risks to the unborn child.
Women of childbearing potential undergoing treatment with Tolerak must use effective contraception during treatment with Tolerak and for up to 6 months after the last application of Tolerak. Consult your doctor if you need advice on contraception.
Men undergoing treatment with Tolerak must use effective contraception and must not father a child during treatment and for up to 3 months after the last application of Tolerak.
It is not known whether Tolerak passes into breast milk. Tolerak must not be used during breastfeeding. If use during breastfeeding is absolutely necessary, breastfeeding must be discontinued.
The use of Tolerak may impair fertility in both women and men. Tolerak is not recommended for women and men who wish to conceive a child.
Driving and using machines
It is unlikely that the treatment will have any effect on the ability to drive or operate machinery.
Tolerak contains:

• Butylhydroxytoluene (E 321):

May cause localized skin reactions (e.g. contact dermatitis) or irritation to the eyes and mucous membranes.

• Cetyl alcohol and stearyl alcohol
  May cause local skin reactions (e.g. contact dermatitis).
• Methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate
  May cause allergic reactions (including delayed reactions).
• Peanut oil, refined (peanut oil)

If you are allergic to peanuts or soya, do not use this medicine.

3. How to use Tolerak

Use this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
How to apply Tolerak
Apply Tolerak once daily to cover the areas of skin to be treated, for 4 weeks as follows:

• Wash, rinse, and gently dry the areas of skin to be treated.
• Apply a thin layer of Tolerak to the affected areas.
• Gently massage Tolerak evenly into the skin.
• Avoid contact with other areas of the body and avoid transferring Tolerak from your body to other people.
• Wash your hands thoroughly after applying Tolerak.

If you use more Tolerak than you should
If Tolerak is applied more often than once daily, the likelihood of experiencing skin reactions may increase, and these reactions could be more severe.
If you or a child accidentally ingest Tolerak, contact a doctor or go to the nearest emergency room immediately.
If you forget to use Tolerak
Do not apply a double dose to make up for a missed dose. Continue treatment as directed by your doctor or as described in this leaflet.
If you stop using Tolerak
Please contact your doctor before stopping treatment, unless you experience any of the following symptoms: mouth ulceration, stomach pain, diarrhoea with blood, vomiting, fever, or chills. In such cases, stop using Tolerak and contact your doctor immediately (see section 2).
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.

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

• Skin reactions at the application site (irritation, pain, reaction, redness, itching sensation, inflammation, oedema (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 sores,
• Nausea,
• Swelling around the eyes (oedema),
• Increased tearing,
• Redness,
• Skin reactions at the application site: bleeding, erosion, eczema, discomfort, dryness, burning/tingling, photosensitivity reaction (increased sensitivity of the skin to sunlight).

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

• Allergic reactions (contact dermatitis)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tolerak

Keep this medicine 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 refers to the last day of that month.
Do not use Tolerak more than 4 weeks after first opening the tube (punctured by the cap).
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Tolerak contains

• The active substance is: fluorouracil
• The other components are: stearoyl 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, peanut oil (refined), sodium hydroxide (E 524), stearic acid and stearyl alcohol.

Description of the appearance of Tolerak and package contents
White to off-white cream in tubes of 20 or 40 g.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
PIERRE FABRE ITALIA S.p.A.
Via G. Washington, 70
20146 Milan – Italy

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

This medicinal product is authorized in the European Economic Area countries under the following names:

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

Other sources of information