EFUDIX 5% CREAM

Active substance: FLUOROURACIL

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ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

This medicine is known by the above name but will be referred to as Efudix or Efudix Cream throughout 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
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.

WARNING!

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.

DATE:

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.

In particular, tell your doctor if you are using:
UK PIL DATED DECEMBER 2013
REPORTING OF SIDE EFFECTS

CODE:

6464/1756A

TVT CHECKED

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.



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.

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Black

WARNING!

DATE:

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.

24/04/14

DT

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.

DATE OF PROOF:

ARTWORKER:

CUSTOMER: Waymade
PRODUCT: Efudix 5% Cream

PRE-PRESS NO.:

05-0440

Q.A.
APPROVED:

CUSTOMER
APPROVED:

After stopping treatment you may find that your skin takes one to two months to heal completely.

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

Notes:

EFUDIX® 5% CREAM
(fluorouracil)
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.

PROOF HISTORY:
v.1 - waymade - 24/04/14

Leaflet Flat Size = 148 x 317

27mm

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

000-0000A

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

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.

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.
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”.

WARNING!

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.

DATE:
24/04/14






TVT CHECKED



UK PIL DATED DECEMBER 2013
REPORTING OF SIDE EFFECTS

DATE OF PROOF:

By reporting side effects you can help provide more information on the safety of this medicine.

6464/1756A

DT
ARTWORKER:

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

CODE:

Q.A.
APPROVED:
05-0440

CUSTOMER: Waymade
PRODUCT: Efudix 5% Cream

PRE-PRESS NO.:

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.

5. How to store Efudix Cream
Do not use after the expiry date printed on the carton or metal tube. The expiry date refers to the last
day of that month.
Efudix 5% cream should not be stored above 25°C.
Keep all medicines out of the sight and reach of children.
If your doctor tells you to stop using the cream, please take it back to the pharmacist for safe
disposal. Only keep the cream if your doctor tells you to.
If the cream becomes discoloured or shows any other signs of deterioration, you should consult your
pharmacist who will advise you what to do.
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
Your medicine is called Efudix 5% cream. Each gram of cream contains 50 milligrams of the active ingredient,
fluorouracil in a white, opaque cream.
Efudix 5% cream also contains the following inactive ingredients:
cetostearyl alcohol, propylene glycol, polysorbate 60, methyl parahydroxybenzoate (E128), propyl
parahydroxybenzoate (E126), white soft paraffin and purified water.
Efudix 5% cream is available as a tube containing 20 grams of cream.
POM

PL No: 6464/1756

This product is manufactured by Valeant Pharmaceuticals Germany GmbH, Dusseldorfer Str: 40A, 65760
Eschborn, Germany and is procured from within the EU and repackaged by the Product Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR
Leaflet revision and issue date (Ref.) 24.04.2014
Efudix is a registered trademark of Valeant Pharmaceuticals International

Colour
Swatch

Black

WARNING!

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.
DATE:

CUSTOMER
APPROVED:

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.

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

Leaflet Flat Size = 148 x 317
Notes:
ARIAL REGULAR FONT SIZE 8

ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

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.

PROOF HISTORY:
v.1 - waymade - 24/04/14

Notes:

27mm

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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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