EFUDIX CREAM

Active substance: FLUOROURACIL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Efudix 5% Cream
Fluorouracil

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

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.

• 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).
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.
Important information about some of the
ingredients of Efudix Cream
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.

2.   BEFORE YOU USE EFUDIX CREAM

3.   HOW TO 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.

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.

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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.

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
• Store Efudix Cream out of the reach and
sight of children.
• Do not store Efudix Cream above 30°C.
• For 20 g and 40 g tubes: 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.

6.   FURTHER INFORMATION
What Efudix Cream contains
Active substance:
Other ingredients:

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.

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Fluorouracil
(at a 5% concentration).
Stearyl alcohol, white soft
paraffin, polysorbate 60,
propylene glycol, E218
(methyl parahydroxy­
benzoate), E216 (propyl
parahydroxybenzoate),
purified water.

What Efudix Cream looks like and contents of
the pack
• Efudix is a white, opaque cream.
• It is supplied in tubes of 20 g and 40 g.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Meda Pharmaceuticals Ltd., Skyway House,
Parsonage Road, Takeley, Bishop’s Stortford,
CM22 6PU, UK.
Manufacturer responsible for batch release
ICN Polfa Rzeszów S.A., ul. Przemysłowa 2,
35-959 Rzeszów, Poland
For any information about this medicine, please
contact the Marketing Authorisation Holder.
This leaflet was last revised in December 2013.

56UK1959140-00 

P1EU06

2014-01-22 12:48:42

Nazwa produktu Product

Efudix 5% Cream

Krój czcionki Fonts Used

Kraj Country

UK

Minion Regular
Minion Bold

Kod komponentu Component code P1EU06
Wymiar ulotki PIL size

148 x 297 mm

Kod farmaceutyczny Pharmacode

392

Rozmiar czcionki Font size

minimum 9 pt

Opracowane przez Designed by

Katarzyna Wojdanowska

Nr korekty Proof Nr
Komentarze Comments

4

Data Date

Kolor nadruku Colours used

– Update SPC to CCDS with a consequential update to the PIL
– MEDA Mat-Nr.: 56UK1959140-00
Podpis i pieczęć Signature and stamp

P1EU_Efudix_UK.indd 3

BLACK

22.01.2014

Data Date

2014-01-22 12:48:43

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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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