Efudix

Leaflet attached to the packaging: patient information

Efudix, 50 mg/g, cream

Fluorouracil

You should read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Efudix and what is it used for
• 2. Important information before using Efudix
• 3. How to use Efudix
• 4. Possible side effects
• 5. How to store Efudix
• 6. Contents of the packaging and other information

1. What is Efudix and what is it used for

Efudix is a medicine belonging to the group of so-called antimetabolites, pyrimidine derivatives. It inhibits DNA and RNA synthesis, which leads to the inhibition of cell divisions. This effect is most pronounced in rapidly dividing cells.
The onset of the medicine's action occurs after 2 to 3 days of its use.
Applying the medicine to skin lesions usually causes redness on their surface, then blisters, later leading to exfoliation of the epidermis, formation of an ulcer, and finally healing (covering with epidermis).
Efudix is used to treat solar and senile keratosis, single and multiple basal cell carcinoma of the skin with difficult-to-reach locations for surgical treatment (surgical treatment is recommended if possible), Bowen's disease, and pre-cancerous skin conditions.

2. Important information before using Efudix

When not to use Efudix

• if the patient has been found to be hypersensitive (allergic) to fluorouracil or any of the other ingredients of Efudix,
• if the patient is using any antiviral medicine belonging to the group of nucleosides (such medicines are usually used to treat herpes),
• if the patient is pregnant or breastfeeding.

Warnings and precautions

Before starting to use Efudix, you should discuss it with your doctor or pharmacist.
If the patient has been diagnosed with a lack of dihydropyrimidine dehydrogenase (DPD) enzyme activity (complete DPD deficiency).
If the patient is currently using or has used any medicine to combat herpes infection within the last 4 weeks - such medicines may increase the risk of side effects associated with the use of Efudix. Therefore, before starting to use Efudix, you should discuss it with your doctor.
It is very important not to apply too much cream and not to apply it to open wounds or skin with broken continuity, as this may cause part of the medicine to be absorbed into the blood, which in very rare cases may lead to severe side effects.
If it is necessary to treat large areas of skin - the total area of skin treated with Efudix should not exceed 500 cm (approx. 23 cm x 23 cm); larger areas should be treated gradually.
You should avoid exposure to UV radiation (e.g. natural sunlight, solarium).
During treatment and for 1-2 months after its completion, photoallergic reactions (unfavorable skin reactions to sunlight) may occur. During this time, you should avoid prolonged sun exposure, wear protective clothing, and use sunscreens.
Covering with bandages or dressings may exacerbate skin inflammatory reactions.
The medicine should be used only under medical supervision (among other things, because certain tests may be necessary during treatment).
Due to the possibility of an inflammatory reaction or ulceration, the medicine should not come into contact with mucous membranes or eyes. After using the medicine, you should wash your hands carefully.

Efudix and other medicines

You should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
It is especially important to inform your doctor about the use of antiviral medicines belonging to the group of nucleosides (brivudine, sorivudine, and similar medicines), which affect the action of Efudix.

Efudix with food and drink

Efudix can be used independently of meals.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor before using this medicine.
Pregnancy
The medicine used during pregnancy may harm the fetus, so it is contraindicated in pregnancy. If you become pregnant during treatment, you should consult a genetic counseling center.
Women of childbearing age / Contraception in women and men
Women of childbearing age must use effective contraception during treatment and for six months after its completion.
Men must use effective contraception and avoid fathering a child during treatment and for three months after its completion.
Breastfeeding
Do not use the medicine during breastfeeding. Due to the risk of serious side effects in breastfed children, you should decide whether to stop breastfeeding or discontinue the medicine.
Effects on fertility
Using Efudix may have a negative effect on fertility in women and men. It is not recommended to use Efudix in men trying to conceive.

Driving and using machines

It is unlikely that treatment will have any effect on the ability to drive and use machines.

Efudix contains stearyl alcohol, propylene glycol, methyl parahydroxybenzoate, and propyl parahydroxybenzoate

The medicine contains stearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis).
The medicine contains 115 mg of propylene glycol (E 1520) per gram of cream. Propylene glycol (E 1520) may cause skin irritation.
Methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate may cause allergic reactions (possible late-type reactions).

3. How to use Efudix

This medicine should always be used as directed by your doctor. If you have any doubts, you should consult your doctor.
The medicine is intended for topical use on the skin.
The usual dose of Efudix is:
Adults
Solar and senile keratosis - the cream is applied to the skin lesions 2 times a day in an amount sufficient to cover the lesions. Treatment should be continued until the formation of an ulcer, then the medicine should be discontinued. The treatment period is usually 2 to 4 weeks. Complete healing is usually achieved within 1-2 months after the end of treatment.
Basal cell carcinoma of the skin - the cream is applied to the skin lesions 2 times a day in an amount sufficient to cover the lesions. Treatment should be continued for at least 3-6 weeks, although in some cases it may be necessary to use it for 10-12 weeks. As with other tumors, you should remain under medical supervision until healing is achieved.

Use in children

Do not use.

Use in the elderly

No dose adjustment is necessary.

Using more than the recommended dose of Efudix

So far, no cases of overdose of Efudix have been reported after topical application.
In the event of oral ingestion of the medicine, overdose symptoms may occur: nausea, vomiting, diarrhea, oral mucositis, changes in blood cell count. You should then contact your doctor as soon as possible, who, if justified, will take appropriate measures to protect against systemic infections, symptomatic treatment, and daily monitoring of white blood cell count.

Missing a dose of Efudix

If you miss a dose of the medicine at the scheduled time, you should use it as soon as possible. However, if the time for the next dose is near, you should skip the missed dose. Do not use a double dose to make up for the missed dose.

Stopping the use of Efudix

Stopping the use of the medicine will cause the loss of its beneficial effect in the conditions for which it is used.
If you have any further doubts about the use of this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Efudix can cause side effects, although not everybody gets them.
If you use too much cream or apply it to an open wound, other side effects may occur, as described below.

If you experience any of the following side effects, you should contact your doctor immediately:

• gastrointestinal disorders, such as abdominal pain (including crampy abdominal pain), diarrhea, vomiting,
• swelling and pain of the tongue and mouth,
• fever and general malaise.

Very rare side effects(may occur less frequently than 1 in 10,000 people):
Blood and lymphatic system disorders: changes in blood test results related to the systemic toxicity of the medicine (pancytopenia, neutropenia, thrombocytopenia, leukocytosis).
Immune system disorders: hypersensitivity reactions (rash at the site of application).
Gastrointestinal disorders: bloody diarrhea, diarrhea, vomiting, abdominal pain, oral mucositis (related to the systemic toxicity of the medicine).
Skin and subcutaneous tissue disorders: erythema multiforme, skin pain, inflammatory or allergic skin changes (e.g. urticaria, itching, skin rash (usually local but also generalized if related to systemic toxicity), redness and swelling of the skin, contact dermatitis, burning, discharge, skin irritation, redness, skin darkening, exfoliation of the epidermis (exposure to sunlight or ultraviolet radiation may exacerbate skin irritation), skin ulceration, photoallergic reaction, skin eruptions with a blister-like character, hair loss.
General disorders and administration site conditions: fever, chills, and mucosal inflammation related to the systemic toxicity of the medicine.
Side effects with unknown frequency(frequency cannot be estimated from available data):
Nervous system disorders: taste disorders, headache, dizziness.
Eye disorders: conjunctival irritation, keratitis, increased lacrimation.
Gastrointestinal disorders: nausea.
General disorders and administration site conditions: bleeding at the application site.
Additionally, side effects have been reported, whose causal relationship with the topical use of Efudix has not been fully proven:
Skin and subcutaneous tissue disorders: skin suppuration, telangiectasia, herpes simplex.
Blood and lymphatic system disorders: eosinophilia, appearance of toxic granulation of granulocytes.
Psychiatric disorders: insomnia, irritability.
Respiratory, thoracic, and mediastinal disorders: nasal mucosal irritation.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of the medicine.

5. How to store Efudix

The medicine should be stored out of sight and reach of children.
Store at a temperature below 25°C.
Do not use this medicine after the expiry date stated on the carton and tube after: EXP. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Efudix contains

The active substance of the medicine is fluorouracil. One gram of the medicine contains 50 mg of fluorouracil.
The other ingredients of the medicine are: white petrolatum, stearyl alcohol, polysorbate 60, propylene glycol, methyl parahydroxybenzoate, propyl parahydroxybenzoate, purified water. See also "Efudix contains stearyl alcohol, propylene glycol, methyl parahydroxybenzoate, and propyl parahydroxybenzoate" in section 2.

What Efudix looks like and contents of the pack

Aluminum tube with a PP cap and a latex ring, containing 20 g of cream, in a cardboard box.

Marketing authorization holder:

Viatris Healthcare Sp. z o.o.
ul. Postępu 21B
02-676 Warsaw

Manufacturer:

ICN Polfa Rzeszów S.A.
ul. Przemysłowa 2
35-959 Rzeszów
Poland

To obtain more detailed information, you should contact the marketing authorization holder:

Viatris Healthcare Sp. z o.o.
tel. 22 546 64 00
[logo of the marketing authorization holder]
Date of last revision of the leaflet:02/2024