TOLERAK 40 mg /G Крем

Содержание инструкции

1. Tolerak 40 mg/g cream
   1. What is Tolerak 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

Package leaflet: information for the patient

Tolerak 40 mg/g cream

fluorouracil

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you use 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 is Tolerak and what it is used for

Tolerak contains the active substance fluorouracil.
Fluorouracil belongs to a group of medicines called antimetabolites that inhibit the growth of cells
(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 area of skin you are treating 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 not previously visible to the naked eye and these abnormalities may
become red and inflamed.
This will likely be followed by inflammation/swelling, possibly some discomfort, skin erosion and,
finally, healing. This is the normal expected response to treatment and demonstrates that Tolerak is working.
Sometimes the response is more severe (see section 4 “Possible side effects”). If your skin gets much worse,
you experience pain or are worried, talk to your doctor. Your doctor may prescribe another cream to relieve any
discomfort.
Skin reactions are temporary and resolve within 2-4 weeks after the end of treatment. Therefore, after
stopping treatment, it is possible that the skin may take about 4 weeks 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 soy
• during pregnancy
• if you are breastfeeding
• if you are using medicines known as nucleoside antiviral agents (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 to the eyes, nose, mouth or other mucous membranes as irritation, local inflammation and ulceration may occur.
• Do not apply Tolerak to open wounds or damaged skin.
• The area of skin treated is likely to become red, and will probably then develop inflammation/swelling, possibly some discomfort, skin erosion and, eventually, healing. This is the normal response expected from the treatment and demonstrates that Tolerak is working. Talk to your doctor if the skin gets much worse, you experience pain or 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, you must wash your hands thoroughly after applying Tolerak.
• In case of accidental exposure, wash your eyes thoroughly with water.
• Allergic reactions (contact eczema) may occur. Tell your doctor if you experience severe itching or if redness develops beyond the area of the treated lesions.
• Exposure to UV rays (e.g. natural sunlight, sunbeds) should be avoided.
• If you know you have reduced or absent activity of the dihydropyrimidine dehydrogenase (DPD) enzyme (partial or total deficiency of DPD).
• Tolerak may cause serious side effects in people who have a deficiency of the dihydropyrimidine dehydrogenase (DPD) enzyme. Stop using Tolerak and contact your doctor immediately if you experience any of the following symptoms: mouth ulceration (mucositis), stomach area (abdominal) pain, bloody diarrhoea, vomiting, fever and chills.

Children and adolescents
Tolerak is not indicated for use in children and adolescents under the age of 18 years.

Other medicines and Tolerak
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines. In particular, tell your doctor if you are using medicines for the treatment of chickenpox or shingles
(brivudine and sorivudine) or if you have used them in the last 4 weeks. These medicines may increase the
possibility of undesirable effects with the use of Tolerak. Therefore, these medicines should not be used
during treatment with Tolerak.

Pregnancy, breastfeeding and fertility
Tolerak must not be used during pregnancy.
If pregnancy occurs during treatment, treatment with Tolerak must be discontinued, contact
your doctor immediately for information on the risks to the baby.
Women of childbearing potential treated with Tolerak must use effective contraceptive measures during treatment
with Tolerak and for up to 6 months after the last application of Tolerak. Talk to your doctor if you need
advice on contraception.
Men treated with Tolerak must use effective contraception and 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 female and male fertility. Tolerak is not recommended in women and
men who wish to conceive a child.

Driving and operating machinery
It is unlikely that the treatment will have any effect on the ability to drive and operate machinery.

Tolerak contains:

• Butylated hydroxytoluene (E 321):

May cause localised 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 ones).
• Refined peanut oil (arachis oil)

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

3. How to use Tolerak

Use this medicine following the instructions of your doctor exactly. If you have any doubts, consult your doctor or the
pharmacist.

How to apply Tolerak
Apply Tolerak once a day to cover the skin areas to be treated, for 4 weeks as follows:

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

If you use more Tolerak than you should
If you apply Tolerak more often than once a day, it may increase the likelihood that skin reactions may occur that could be more serious.
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 one of the
following symptoms appears: mouth ulceration, stomach pain, diarrhoea with blood, vomiting,
fever and chills. In this case, stop using Tolerak and consult your doctor immediately (see paragraph
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, edema (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 (edema),
• 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).

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

• Allergic reactions (contact dermatitis)

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through 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 at a temperature above 25 °C
Do not use this medicine after the expiry date which is stated on the pack after EXP. The expiry date refers to the last day of that month.
Do not use Tolerak after 4 weeks from the first opening of the tube (pierced by the cap).
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Tolerak contains

• The active ingredient is:fluorouracil
• The other ingredients are:stearoyl-macrogol glycerides, butylated hydroxytoluene (E 321), cetyl alcohol, citric acid (E 330), glycerol (E 422), isopropyl myristate, methyl gluceth-10, methylparaben (E 218), propylparaben, purified water, peanut oil (refined), sodium hydroxide (E 524), stearic acid and stearyl alcohol.

Description of the appearance of Tolerak and contents of the pack
Cream from white to off-white in a tube of 20 or 40 g
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
PIERRE FABRE ITALIA S.p.A.
Via G. Washington, 70
20146 Milano – Italy

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

This medicinal product 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, Slovak Republic, Spain, Sweden, United Kingdom
• Tolerak: Finland, Italy
• Efflurak: Belgium, Luxembourg, Portugal.

Other sources of information