What Tolak is and what it is used for
Tolak contains the active substance fluorouracil.
Fluorouracil belongs to a group of drugs called antimetabolites, which inhibit cell growth (so-called cytostatics ).
Tolak is used to treat a skin condition called actinic keratosis (sun-damaged skin) of grades I and II on the face, ears, and/or scalp in adults.
The fluorouracil contained in Tolak may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
Information about how Tolak works
When you use Tolak, you will probably experience redness in the treated skin.
Tolak destroys cancer cells and precursors to cancer cells in the skin and does not affect normal cells as much.
Tolak also treats abnormal skin conditions that have not been visible to the naked eye, and these may become red and inflamed.
This is likely to be followed by inflammation/swelling, possibly some discomfort, superficial ulceration and ultimately healing. This is the expected normal reaction to the treatment and means that Tolak is working.
Sometimes the reaction can be more severe (see section 4, “Possible side effects”). Talk to your doctor if your skin worsens, or if you feel pain or worry. The doctor can prescribe a cream that relieves the discomfort.
The skin reactions are transient and disappear within 2 to 4 weeks after the end of treatment. So it can take about 4 weeks for the skin to heal after the treatment is finished.
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 breastfeeding
- if you are using any nucleoside antiviral medicines (eg brivudine or sorivudine). These drugs are commonly used to treat chickenpox or shingles.
Warnings and precautions
Talk to your doctor or pharmacist before using Tolak.
- Do not apply Tolak directly to the eyes, nose, mouth, or other mucous membranes as this may lead to irritation, local inflammation, and ulceration.
- Do not apply Tolak to open wounds or damaged skin.
- The area of skin being treated is likely to be reddened, likely followed by inflammation or swelling, possibly with some discomfort, superficial ulceration, and eventually healing. This is the expected normal reaction to the treatment and means that Tolak is working. Talk to your doctor if your skin worsens, or if you feel pain or worry. The doctor can prescribe a cream that relieves the discomfort.
- Do not apply Tolak under bandages or dressings, as this may increase inflammatory reactions in the skin.
- To avoid transferring the medicine to the eyes and/or contact lenses and the area around the eyes during and after application, wash your hands thoroughly after applying Tolak.
- If you accidentally get Tolak in your eye(s), rinse with copious amounts of water.
- Allergic reactions (contact dermatitis) may occur. Tell your doctor if you get severe itching or redness outside the treated skin area.
- Avoid ultraviolet radiation (eg natural sunlight or tanning beds).
- If you know that you have reduced or no activity of the enzyme dihydropyrimidine dehydrogenase (DPD) ( partial or complete DPD deficiency). Tolak can cause severe side effects in people who are deficient in the enzyme dihydropyrimidine dehydrogenase (DPD). Stop using Tolak and contact your doctor immediately if you experience any of the following symptoms: mouth sores ( mucositis ), stomach pain, bloody diarrhea, vomiting, fever, or chills.
Children and young people
Tolak should not be used in children and adolescents under the age of 18.
Other medicines and Tolak
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. You must tell us if you are taking medicines for chickenpox or shingles (brivudine or sorivudine) or have used them in the last 4 weeks. These medicines can increase the risk of side effects from Tolak. They must therefore not be used with Tolak.
Pregnancy, breastfeeding, and fertility
Tolak must not be used during pregnancy.
Women who can become pregnant should use effective contraception during treatment with Tolak and for one month after the last dose of Tolak. Talk to your doctor if you need advice on contraception.
If you become pregnant during treatment, you must inform your doctor immediately to discuss the risk of birth defects.
It is unknown if Tolak passes into breast milk. Tolak must not be used during breastfeeding. If use during breastfeeding is necessary, breastfeeding must be discontinued.
The use of Tolak may impair fertility in women and men. Tolak is not recommended for women or men planning to have children.
Driving ability and use of machinery
The treatment probably does not affect the ability to drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
Tolak contains excipients
- Butyl hydroxytoluene (E 321):
This substance can cause local skin reactions (e.g. contact dermatitis), or be irritating to the eyes and mucous membranes.
- Cetyl alcohol and stearyl alcohol
These can cause local skin reactions (e.g. contact dermatitis).
- Methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate
These can cause allergic reactions (possibly delayed).
- Peanut oil, refined
If you are allergic to peanuts or soya, you should not use this medicine
How to use Tolak
Always use this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
Apply Tolak like this
Apply Tolak once daily over the skin surface to be treated. Treatment must last for 4 weeks, as follows:
- Wash, rinse, and gently pat dry the skin areas to be treated.
- Apply a thin layer of Tolak to the areas to be treated.
- Gently massage Tolak into the skin in an even layer.
- Do not allow Tolak to come into contact with other areas of the body. Do not transfer Tolak from your own body to other people.
Wash your hands thoroughly after applying
If you have used too much Tolak
If you have used Tolak more often than once a day, the likelihood of skin reactions is greater and they may also be more severe.
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
If you forget to use Tolak
Do not use a double dose to make up for a missed dose. Continue the treatment as prescribed by the doctor or as described in this leaflet.
If you stop using Tolak
Consult a doctor before you stop using Tolak unless you develop any of the following symptoms: mouth ulcers, stomach pain, bloody diarrhea, vomiting, fever, or chills. In this case, stop using Tolak and contact a doctor immediately (see section 2).
If you have any further questions about this medicine, ask your doctor or pharmacist.
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)
- Swine pox (bacterial infection of the skin)
- Sore throat ( pharyngitis )
- Insomnia
- Trouble from the nose
- Blisters on the lips
- Nausea
- Swelling around the eyes ( edema )
- Increased tear production
- Redness
- Skin reactions at the application site: bleeding, superficial ulceration, eczema, discomfort, dryness, burning/tingling, photosensitivity (increased sensitivity to sunlight).
Has been reported (occurring in an unknown number of users): Allergic reactions (contact dermatitis)
How Tolak should be stored
Keep this medicine out of the sight and reach of children.
Store at a maximum of 25 °C.
Use before the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
Tolak should not be used after 4 weeks have passed after opening the tube (when it has been perforated by the screw cap).
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is fluorouracil.
- Other ingredients are stearoyl macroglycerides, butyl hydroxytoluene (E 321), cetyl alcohol, citric acid (E 330), glycerol (E 422), isopropyl myristate, methylglucet-10, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate, purified water, peanut oil (refined), sodium hydroxide (E 524), stearic acid and stearyl alcohol
Appearance and package sizes of the medicine
White to off-white cream in tubes of 20 grams or 40 grams
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Pierre Fabre Dermatology
45, place Abel Gance
92 100 Boulogne
France
Manufacturer:
Pierre Fabre Medicament Production,
Parc Industrial de la Chartreuse
81100 Castres
France
Local Representative:
Pierre Fabre Pharma Norden AB
Karlavägen 108
115 26 Stockholm
This medicine is approved in the European Economic Area under the names:
- Tolak: Austria, Czech Republic, Denmark, France, Germany, Greece, Netherlands, Norway, Poland, Slovakia, Spain, Sweden, United Kingdom
- Tolerak: Finland, Italy
- Efflurak: Belgium, Luxembourg, Portugal