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EFUDIX CREAM

Active substance(s): 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 because it contains
important information for you.
• 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
only. Do not pass it on to others. It may harm
them, even if their signs of illness are the same
as yours.
• If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Efudix Cream is and what it is used for
2. What you need to know before you use Efudix
Cream
3. How to use Efudix Cream
4. Possible side effects
5. How to store Efudix Cream
6. Contents of the pack and other 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.

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.

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Warnings and precautions
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.
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.
An effective method of contraception must be used
during treatment with Efudix Cream.
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
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).

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• E218 (methyl parahydroxybenzoate) and
E216 (propyl parahydroxybenzoate), which can
cause allergic reactions.

–– Rash on areas other than where the cream was
applied
–– Hair loss

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

Not known (frequency cannot be estimated from
the available data)
–– Painful and/or watering eyes
–– Taste disturbance
–– Headache, dizziness, nausea

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:
–– 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.

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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 this medicine out of the sight and reach of
children.
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.
Do not store Efudix Cream 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.

6. Contents of the pack and other
information
Active substance:
Other ingredients:

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 and
Manufacturer
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 March 2016

56UK1959140-02 

P1EU08

2018-03-12 11:58:31

Graphics&Packing
Technology Section
ICN POLFA RZESZÓW S.A.

Nazwa produktu
Product Name

ULOTKA PIL

Efudix 5% Cream

Kolor nadruku Colours

/Fluorouracil/

Black
Kraj
Country (ISO)

Nr wykrojnika
Spec No

-

Kod Wytwórcy
Manufacturer code

-

Kod farmaceutyczny
Pharmacode

392

P1EU08

Inny kod
Other code

56UK1959140-02

minimum 9 pt

Wymiar ulotki
PIL size

148 x 297 mm

GB
Katarzyna Wojdanowska

Opracowane przez
Designed by

katarzyna.wojdanowska@
valeant.com

phone: +4817 865 5586
Nr korekty
Proof No
Kod wersji
Valeant version code
Rozmiar czcionki
Font size
Krój czcionki
Font used

2

Data
Date

12-03-2018

Minion Pro Font Family

Gramatura papieru
Paper weight

50 g/m²

Komentarze Comments (Reason for the change)
– update of PIL to align with Meda’s CCDS v2.0 and v3.0
– PMR_ICN-18-0235

Akceptacja Techniczna Technical Approval

Akceptacja Działu ds. Rejestracji Regulatory Affairs Dept. Approval

P1EU08_Efudix_UK.indd 3

2018-03-12 11:58:31

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Further information

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