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Active substance: FLUOROURACIL

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Patient Information Leaflet

Efudix® 5% w/w Cream / Fluorouracil 5% w/w Cream
Read all of this leaflet carefully before you start using this medicine.
 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. Do not pass it on to others.
It may harm them, even if their symptoms are the same as yours.
 If you experience any side effect and this becomes serious, tell your
doctor or pharmacist.
 Your medicine is available using either of the above names but will be
referred to as Efudix Cream throughout the remainder of this leaflet.
In this leaflet:
1) What Efudix Cream is and what it is used for
2) Before you use Efudix Cream
3) How to use Efudix Cream
4) Possible side effects
5) How to store Efudix Cream
6) Further information
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.

Using other medicines
Tell your doctor or pharmacist if you are taking or have recently taken
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 and breast-feeding
Do not use Efudix Cream and tell your doctor if you are pregnant, think
you might be pregnant or you are breast-feeding.
Important information about some of the ingredients of Efudix
Efudix Cream contains some ingredients that can cause side effects.
These are:
 stearyl alcohol and propylene glycol, which can cause local skin
irritations (e.g. contact dermatitis, which is an inflammation of the skin).
 E218 (methyl parahydroxybenzoate) and E216 (propyl
parahydroxybenzoate), which can cause allergic reactions.
Do not use Efudix if you are allergic to any of its ingredients.

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
Do not use Efudix Cream if you:
 are allergic (hypersensitive) to fluorouracil or any other ingredients in
this medicine (these are listed in section 6, “Further Information”).
 are pregnant, think you may be pregnant, or are breast-feeding.
 are using any medicines known as antiviral nucleosides (e.g.
brivudine, sorivudine). These medicines are usually used to treat
chickenpox or shingles.
Efudix Cream is not for use in anyone under 18 years of age.
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
 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 reduced activity/deficiency of the enzyme DPD
(dihydropyrimidine dehydrogenase).
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.

Always use Efudix Cream exactly as your doctor has told you. You must
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
 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
 Wash your hands thoroughly after using this cream.
 Your doctor will tell you if you need to apply a dressing to the treated
 Never treat an area of skin larger than 23 x 23cm (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 the missed dose.
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”.

The unwanted effects are:
Relating to the skin and subcutaneous tissue. Itching, redness, burning
sensation, severe peeling, intense swelling or inflammation, ulceration,
blistering, irritation, pain 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.
General side effects:
 Sores which are red, round and painful.
 Rash on areas other than where the cream was applied.
 Other side effects may occur if you use too much cream or if you apply
the cream to open cuts. These side effects are listed below.
You must tell your doctor IMMEDIATELY if you experience any of
these side effects:
- Stomach problems such as pain, cramps, diarrhoea and vomiting
- swelling and soreness of the mouth and tongue
- fever or feeling generally unwell.
Consult your doctor or pharmacist if you are concerned about any
of the above effects or if you notice any additional side effects not
listed in this leaflet.

Keep out of the sight and reach of children.
Do not store above 30°C.
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.
 If your medicine becomes discoloured or shows any sign of
deterioration, return it to your pharmacist.
 Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.
What Efudix Cream contains
The active ingredient in Efudix Cream is fluorouracil 5% w/w.
The other ingredients are:
Stearyl alcohol, White soft paraffin, Polysorbate 60, Propylene glycol,
Methyl parahydroxybenzoate (E218), Propyl parahydroxybenzoate
(E216), Purified water.
What Efudix Cream looks like and contents of the pack
Efudix Cream is a smooth white opaque, homogeneous cream. It comes
in an aluminium tube with a plastic screw cap and enclosed in a printed
Efudix Cream is supplied in cartons containing either 1 tube of 20g or
2 tubes of 20g.
ICN Polfa Rzeszów S.A.
ul. Przemysłowa 2
35-959 Rzeszów
Procured from within the EU by the Product Licence holder
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall, WS9 8ER, UK
PL: 33532/0422



Leaflet date: 9 September 2013
Leaflet code: XXXXXXXXXX
Efudix® is a registered trademark of

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.