Tolak 40 mg/g cream

• 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.

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

When you use Tolak it is likely that the area of the skin that you are treating will become red.

Tolak destroys cancerous and pre-cancerous cells of the skin, while having less effect on normal cells. Tolak will also treat abnormalities of the skin that were previously not visible to the naked eye, and these abnormalities may become red and inflamed.

There will probably be a redness (erythema) followed by an inflammation/swelling, possibly some discomfort, damaged skin (erosion) and, eventually, healing. This is the expected normal response to treatment and shows that Tolak is working.

Sometimes the response is more severe (see section 4 “Possible Side Effects”). If your skin becomes much worse, you experience pain or if you are worried, talk to your doctor. Your doctor may prescribe another cream to relieve any discomfort.

The skin reactions are transient, generally mild to moderate with a peak at 4 weeks and resolve within 2-4 weeks after the end of treatment. The response to treatment usually occurs in the second week of application. Therefore, after stopping treatment, you may find that your skin takes approximately 4 weeks to heal.

• If you are allergic (hypersensitive) to the active substance (fluorouracil) or any of the other ingredients of this medicine (listed in section 6)
• If you are allergic (hypersensitive) to peanut or soya
• If you are pregnant
• If you are breast-feeding
• If you are using any medicines known as antiviral nucleosides (e.g. brivudine and sorivudine).
  These medicines are usually used to treat chickenpox or shingles (see section Other medicines and Tolak).

Talk to your doctor or pharmacist before using Tolak.

• Do not apply Tolak directly into eyes, nose, mouth, or other mucous membranes because irritation, local inflammation and ulceration can occur. Should such contact occur, the cream is to be washed off with plenty of water.
• Do not apply Tolak on open wounds or damaged skin.
• It is likely that the area of the skin treated will become red, probably followed by inflammation/swelling, possibly some discomfort, skin erosion and eventually, healing. This is the expected normal response to treatment and it shows that Tolak is working. Talk to your doctor if your skin becomes much worse, you experience pain or if you are worried. Your doctor may prescribe you another cream to relieve any discomfort.
• Do not apply Tolak under bandages or dressing as this may increase inflammatory reactions of the skin.
• Issues of the cornea and the conjunctiva (layers covering the eye) have been reported with fluorouracil applied on skin. Avoid application around the eyes. To avoid transfer of the drug into the eyes and/or contact lenses and to the area around the eyes, you should wash hands well after applying Tolak.
• If accidental exposure occurs, you should flush eye(s) with large amounts of water.
• Allergic reactions (contact eczema) can occur. Tell your doctor if you experience severe itching or if redness develops at application site or beyond the treated lesions.
• Sunburn-like reactions following exposure to light (photosensitivity reaction) have been reported with fluorouracil applied on skin. Exposure to UV-radiation (e.g. natural sunlight, tanning salon) should be avoided during treatment with Tolak.
• If you know that you have reduced or no activity of the enzyme dihydropyrimidine dehydrogenase (DPD) (partial or complete DPD deficiency), talk to your doctor or pharmacist before using Tolak. Indeed, Tolak might cause serious side effects in people who do not have enough of this enzyme. Stop using Tolak and call your doctor immediately if you present any of the following symptoms: sores in your mouth and/or throat (stomatitis), mucosal inflammation (mucositis), stomach-area (abdominal) pain, diarrhea (bloody or not), vomiting, fever or chills.

Tolak is not intended for use in children and adolescents under 18 years of age.

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 to treat chickenpox or shingles (brivudine and sorivudine) or have used them within the last 4 weeks. These medicines may increase the possibility of unwanted effects with Tolak. Therefore, these medicines must not be used with Tolak.

Tolak must not be used during pregnancy.

If you become pregnant during treatment, Tolak treatment must be interrupted, contact your doctor immediately for advice about the risk for the child.

Women of childbearing potential on treatment with Tolak must use an effective contraception during treatment and up to 6 months after the last dose of Tolak. Talk to your doctor if you need advice on contraception.

Men under Tolak treatment must use effective contraception and not father a child during treatment and up to 3 months after the last dose of Tolak.

It is not known if Tolak passes into your breast milk. Tolak must not be used during breast-feeding. If use during breastfeeding is absolutely necessary, breastfeeding must be discontinued.

The use of Tolak may impair female and male fertility. Tolak is not recommended in women and men attempting to have a child.

It is unlikely that treatment will have any effect on the ability to drive and use machines when used according to the dosage instructions.

• Butylhydroxytoluene (E321):
  It may cause local skin reactions (e.g., contact dermatitis), or irritation to the eyes and mucous membranes.
• Cetyl alcohol and stearyl alcohol
  They may cause local skin reactions (e.g., contact dermatitis).
• Methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate
  They may cause allergic reactions (possibly delayed).
• Arachis oil, refined (peanut oil)
  If you are allergic to peanut or soya, do not use this medicinal product.

Apply Tolak once daily to cover the areas of your skin to be treated, for 4 weeks as follows:

• Wash, rinse, and pat dry gently the skin areas to be treated.
• Apply a thin film of Tolak to the areas to be treated.
• Massage gently and uniformly Tolak evenly into your skin using the fingertips.
• Avoid contact with other areas of your body, and transfer of Tolak from your body to other people.
• Wash your hands thoroughly after you have applied Tolak.

If you apply Tolak more often than once daily, you will be more likely to experience reactions at the application site and they may be more severe.

If you or a child swallow Tolak by mistake, please contact a doctor or go to your nearest emergency department immediately. If accidental ingestion occurs, signs of fluorouracil overdosage may include: nausea, vomiting, diarrhea, sores in your mouth or throat (stomatitis). Blood disorders may occur in severe cases.

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

Please contact your doctor before stopping treatment unless you present any of the following symptoms: sores in your mouth and/or throat (stomatitis), mucosal inflammation (mucositis), stomach-area (abdominal) pain, diarrhea (bloody or not), vomiting, fever or chills. In that case, stop using Tolak and call your doctor immediately (see section 2).

If you get 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 via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects, you can help provide more information on the safety of this medicine.

• The active substance is: fluorouracil

One gram of Tolak contains:

Fluorouracil…………………………………………………………………………………..40.0 mg

• The other ingredients are:
  • Purified water
  • Arachis oil, refined*
  • Isopropyl myristate
  • Methyl gluceth-10
  • Stearoyl macrogolglycerides
  • Glycerol (E 422)
  • Cetyl alcohol*
  • Stearyl alcohol*
  • Sodium hydroxide (E 524)
  • Stearic acid
  • Butylhydroxytoluene* (E 321)
  • Methyl parahydroxybenzoate* (E 218)
  • Citric acid (E 330)
  • Propyl Parahydroxybenzoate*

* See section 2 ‘Tolak contains’

White to off white cream in tube of 20 or 40 g

Not all pack sizes may be marketed.

The Marketing Authorisation Holder is

The Manufacturer is