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EFUDIX 50 MG/G CREAM

Active substance(s): FLUOROURACIL

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T05723

Efudix® 50 mg/g Cream
(5-fluoro-uracil)

Patient Information Leaflet.
This medicine is available using the above
name but will be referred to as Efudix Cream
throughout the Patient Information Leaflet.
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 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

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.
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.

1. WHAT EFUDIX CREAM IS AND WHAT
IT IS USED FOR

Important information about some of the
ingredients of Efudix Cream

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.

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.

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. BEFORE YOU USE EFUDIX CREAM
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 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).

Do not use Efudix if you are allergic to any of its
ingredients.

3. HOW TO USE EFUDIX CREAM
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
• 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 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.

BACK PAGE
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”.
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, 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.
• 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.
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 Efudix Cream out of the sight and
reach of children.
• Do not store Efudix Cream above 25°C.
• Do not refrigerate or freeze.
• After opening Efudix Cream, use within
3 months. After use close tube tightly.
• 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.
• 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.

6. FURTHER INFORMATION
What Efudix Cream contains
Each 1 g of cream contains the active ingredient
5-fluoro-uracil 50 mg/g.
The other ingredients (excipients) are: stearyl
alcohol, white soft paraffin, polysorbate 60
(E435), macrogol, methyl parahydroxybenzoate
(E218), propyl parahydroxybenzoate (E216),
purified water.
What Efudix Cream looks like and contents
of the pack
Efudix is a white, opaque cream.
It is supplied in tubes of 40 g.
Manufacturer and Product Licence Holder
This product is manufactured by ICN Polfa
Rzeszów S.A., ul. Przemysłowa 2, 35-959
Rzeszów, Poland. It is procured from within the
EU by the Product Licence Holder: Swinghope
Limited, Brandon House, Marlowe Way,
Croydon CR0 4XS UK. Repackaged by
Interport Limited, Brandon House, Marlowe
Way, Croydon CR0 4XS UK.

POM
PL No: 10380/1590
Leaflet revision date: 19/10/2015
Efudix® is registered trademark of Meda AB,
Sweden.
T05723

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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.

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