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EFUDIX 5% CREAM

Active substance(s): FLUOROURACIL / FLUOROURACIL

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

Efudix® 5% Cream
(fluorouracil)
The above product is available by the above name but will be referred
to as Efudix Cream throughout the remainder of this leaflet.

Closing bandages or dressing may increase inflammatory reactions of
the skin.

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.

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.

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.

In this leaflet:

Driving and using machines

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

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

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
Cream

Important Information About How Efudix Works

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 Cream if you are allergic to any of its ingredients.

Efudix destroys cancerous and pre-cancerous cells, while having little
effect on normal cells.

3. HOW TO USE EFUDIX 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.

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.

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
away:
 You get this cream in your eyes, nose or mouth.
 Someone else accidentally uses this cream.

How to apply Efudix Cream
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.

 Only use Efudix Cream on the skin and avoid contact with the eyes

2. BEFORE YOU USE EFUDIX CREAM

 It is very important that you do not use too much cream and do not

and mouth.
 Apply a thin layer of the cream to the affected area as instructed by

your doctor.

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.






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 23cm (9 x 9 inches) at
any one time. This area is approximately the size of a dinner plate.

Take special care with Efudix Cream if you:

If you forget to use Efudix Cream

 are applying this cream around your eyelids, nose or lips, and avoid

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.

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 reduced activity/deficiency of the enzyme DPD
(dihydropyrimidine dehydrogenase).

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
Cream is described in Section 1, under “How Efudix Cream works”.

Sunlight may increase the effects of Efudix Cream. 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.

The unwanted effects are:

Exposure to UV-radiation (e.g) natural sunlight, tanning salon) should
be avoided.

These are generally a severe response to treatment and usually occur
in the areas of the skin where the cream has been applied.

S0634-IRE-PIL-16.02.2017

 Relating to the skin and subcutaneous tissue. Itching, redness,

burning sensation, severe peeling, intense swelling or inflammation,
ulceration, blistering, irritation, pain, hives and rash.

 Painful and/or watering eyes.
 Hair loss.
 Taste disturbance.

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.
The following side effects with a frequency not known have been
recorded: headache, dizziness, nausea
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.

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.
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.
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.
 Any unused Efudix cream should be returned to your pharmacist for
safe disposal.
 Medicines must 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.
 If the cream looks to be deteriorating in any way, do not use and
return it to the pharmacist.

6. FURTHER INFORMATION
What Efudix Cream contains
Active substance: Fluorouracil (at a 5% w/w).
Other ingredients: 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 the contents of the pack
Smooth, white, opaque cream.
It is supplied in packs of 20 g and 40 g.

Manufactured by:
ICN PolfaRzeszów S.A.,
ul. Przemyslowa 2, 35-959
Rzeszów, Poland

Procured from within the EU and repackaged by:
Amimed Direct Ltd, Hendon, London, NW9 6AQ.

Product Licence Holder:
Sam Pharma Ltd, Unit 20 Garrick Industrial Estate, Irving Way,
Hendon, London, NW9 6AQ.
POM

PL 33902/0634

This leaflet was last revised: 16/02/2017.
Efudix® is a registered trademark of Meda AB.

Blind or partially sighted? Is this leaflet
hard to see or read? Call 02082033203
to obtain the leaflet in a format suitable
for you.
S0634-IRE-PIL-16.02.2017

Expand Transcript

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.

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