Patient leaflet - Efudix 5% w/w cream
1. What Efudix Cream is and what it is used for
Efudix Cream is used to treat skin conditions such as growths of the skin (keratoses) and some simple skin cancers. The active ingredient fluorouracil belongs to a group of anti-cancer medicines.
Important Information about How Efudix Works
Efudix destroys cancerous and pre-cancerous cells, while having little effect on normal cells.
When you use Efudix it is likely that the area of the skin that you are treating will become red. This will probably be followed by inflammation/swelling, possibly some discomfort, skin erosion and eventually, healing. This is the expected normal response to treatment and shows that Efudix 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 you
another cream to relieve any discomfort.
After stopping treatment, you may find that your skin takes one to two months to heal completely.
Efudix will also treat abnormalities of the skin that were previously not visible to the naked eye, and these abnormalities may become red and inflamed.
2. What you need to know before you use Efudix Cream
Do not use Efudix Cream:
- if you are allergic to fluorouracil or any other ingredients in this medicine (listed in section 6).
- if you are pregnant, think you may be pregnant, or are breast-feeding.
if you are using any medicines known as antiviral nucleosides (e.g.
brivudine, sorivudine). These medicines are usually used to treat
chickenpox or shingles.
Warnings and precautions
Talk to your doctor or pharmacist before taking Efudix Cream:
- if you know that you have reduced or no activity of the enzyme dihydropyrimidine dehydrogenase (DPD) (partial or complete DPD deficiency).
Take special care with Efudix Cream if you:
- are applying this cream around your eyelids, nose or lips, and avoid
contact with the eyes or mouth (see section 3, “How to use Efudix
Cream”).
- have open cuts. Do not use this cream on open cuts as this can lead
to too much cream being absorbed into the blood, which very rarely,
can cause side effects.
- have ulcerated or inflamed skin. Do not use this cream on ulcerated or inflamed skin as this can lead to too much cream being absorbed into the blood, which very rarely, can cause side effects.
Do not smoke or go near naked flames – risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard.
Washing clothing and bedding may reduce product build-up but not totally remove it.
Sunlight may increase the effects of Efudix. This may result in increased skin reactions. To prevent this you must try to stay out of direct sunlight as much as possible while using the cream and must not use a sunlamp or sun bed.
Exposure to UV-radiation (e.g.) natural sunlight, tanning salon) should be avoided. Closing bandages or dressing may increase inflammatory reactions of the skin.
Children and adolescents
Efudix Cream is not for use in anyone under 18 years of age.
Other medicines and Efudix Cream
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. This is very important, as using more than one medicine at the same time can strengthen or weaken the effect of the medicines involved.
In particular, tell your doctor if you are using:
- medicines to treat chickenpox or shingles (brivudine,
sorivudine) or have used them in the last 4 weeks. These medicines may increase the possibility of unwanted effects with
Efudix Cream.
Pregnancy, breast-feeding and fertility
Do not use Efudix Cream and tell your doctor if you are pregnant, think you might be pregnant.
Females of childbearing potential under treatment must use effective contraceptive during treatment and for 6 months after treatment.
Male patients (or their female partners of childbearing potential) must use effective contraception during treatment and for 3 months after treatment.
If you become pregnant during treatment inform your doctor immediately and make use of genetic counselling.
Do not use Efudix Cream and tell your doctor if you are breast-feeding. If use during breastfeeding is absolutely necessary, breast-feeding must be discontinued.
The use of Efudix Cream may impair female and male fertility. Efudix Cream is not recommended in men attempting to father a child.
Driving and using machines
It is unlikely that the treatment will have any effect on your ability to drive or use machines.
Efudix Cream contains
Methyl parahydroxybenzoate (E218) and propyl
parahydroxybenzoate (E216): May cause allergic reactions
(possibly delayed).
- Propylene glycol: May cause skin irritation. Because this medicine contains propylene glycol, do not use it on open wounds or large areas of broken or damaged skin (such as burns) without checking with your doctor or pharmacist.
Stearyl alcohol: May cause local skin irritations (e.g. contact dermatitis, which is an inflammation of the skin).
Do not use Efudix if you are allergic to any of its ingredients.
3. How to use Efudix Cream
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
If you think that the effect of your medicine is too weak or strong, talk to your doctor. Do not change your dose without asking your doctor.
If you swallow some cream contact your doctor, pharmacist or go to your nearest hospital straight away.
If any of the following occur, wash the cream off using water, then contact your doctor, pharmacist or go to your nearest hospital straight away:
- You get this cream in your eyes, nose or mouth.
- Someone else accidentally uses this cream.
How to apply Efudix
- Only use Efudix Cream on the skin and avoid contact with the eyes
and mouth.
- Apply a thin layer of the cream to the affected area as instructed by
your doctor.
- It is very important that you do not use too much cream and do not
apply the cream on open cuts. This may lead to some cream being
absorbed into the blood and, very rarely, this can cause side effects.
- The cream is usually used once or twice a day for at least three to four
weeks.
- Wash your hands thoroughly after using this cream.
- Your doctor will tell you if you need to apply a dressing to the treated
skin.
- Never treat an area of skin larger than 23 x 23 cm (9 x 9 inches) at
any one time. This area is approximately the size of a dinner plate.
If you forget to use Efudix Cream
If you miss a dose, apply the cream as soon as possible. However, if it is nearly time for your next dose, skip the missed dose and carry on as
before. Do not apply a double dose to make up for a forgotten dose.
4. Possible side effects
Like all medicines, Efudix Cream can cause side effects, although not everybody gets them.
The usual response to treatment with Efudix is described in Section 1, under “How Efudix works”.
You must tell your doctor IMMEDIATELY if you experience any of these side effects as they may be signs of an allergic reaction:
- Stomach problems such as pain, cramps, diarrhoea and vomiting
- Swelling and soreness of the mouth and tongue
- Fever or feeling generally unwell.
These side effects may occur if you use too much cream or if you apply the cream to open cuts.
Other side effects are:
Very rare (may affect up to 1 in 10,000 people)
Relating to the skin and subcutaneous tissue: itching, redness, burning sensation, severe peeling, intense swelling or inflammation, ulceration, blistering, irritation, pain, hives and rash. These are generally a severe response to treatment and usually occur in the areas of the skin where the cream has been applied.
Exposure to sunlight may increase the intensity of the reaction.
- Rash on areas other than where the cream was applied
- Hair loss
- Change in the level of blood cells
- Diarrhoea with bleeding.
Not known (frequency cannot be estimated from the available data)
- Painful and/or watering eyes
- Taste disturbance
- Headache, dizziness, nausea
- Bleeding at the application site.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme at: 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.
5. How to store Efudix Cream
- Keep out of the sight and reach of children.
- Once opened, use within 90 days.
- Do not use Efudix Cream after the expiry date which is stated on the tube and the outer carton after “EXP”. The expiry date refers to the last day of that month.
Do not store above 30°C.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
If your cream becomes discoloured or shows signs of deterioration, seek the advice of your pharmacist who will tell you what to do.
6. Contents of the pack and other information
What Efudix Cream contains
Each tube contains 20 g or 40 g of 5% w/w fluorouracil.
Also contains stearyl alcohol, white soft paraffin, polysorbate 60, propylene glycol (E1520), methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216) and purified water.
What Efudix Cream looks like and contents of the pack
White, opaque cream, in an aluminium tube with a white plastic screw cap.
Available in packs containing 2 x 20 g tubes or 1 x 40 g tube.
Manufactured by ICN Polfa Rzeszów S.A., ul. Przemysłowa 2,
35-959 Rzeszów, Poland.
Procured from within the EU and repackaged by Product Licence Holder Uni Health Distribution Ltd, Unit G4 Riverside Industrial
Estate, Riverside Way, Dartford, Kent, DA1 5BS.
PLGB 45396/0088 POM
Leaflet date: 10 June 2024 Ref: Efu40I/UT4
Efudix is a registered trademark of Meda AB.
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