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T06647

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

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.    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).

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.

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.

Driving and using machines

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

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.

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 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 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”.

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.

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/vellowcard. 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 Rzeszbw S.A., ul. Przemystowa 2, 35-959 Rzeszbw, Poland. It is procured from within the EU by the Product Licence Holder: Swinghope Limited, Brandon House, Marlowe Way, Croydon CR0 4XS, UK and repackaged by YMD Pharma Ltd, Commerce Way, Edenbridge, TN8 6ED, UK.

PL No: 10380/1590

Leaflet revision date: 09/09/2016

Efudix^® is registered trademark of Meda AB, Sweden.

T06647