Patient Information Leaflet

EFUDIX® 5% Cream

Fluorouracil

Please read this leaflet carefully before you start to take your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

WHAT IS EFUDIX CREAM?

Efudix Cream contains the active ingredient fluorouracil, which belongs to a group of medicines known as antimetabolites, at a concentration of 5%. It works by interfering with the growth of abnormal cells which are eventually destroyed. It also contains the inactive ingredients stearyl alcohol, white soft paraffin, polysorbate 60, propylene glycol, methyl parahydroxybenzoate (methyl paraben), propyl parahydroxybenzoate (propyl paraben) and purified water.

The cream is supplied in tubes of 20 g and 40 g.

WHAT IS EFUDIX CREAM USED FOR?

Efudix Cream is used to treat certain skin conditions caused by abnormal cell growth including different types of keratoses (a horny growth of the skin), kerato-canthoma (a firm nodule on the skin), Bowen’s disease and some simple skin cancers.

WHEN MUST EFUDIX CREAM NOT BE USED?

• If you are pregnant or breast feeding.
• If you are allergic to Efudix Cream or any of its ingredients including parabens.
• It is not recommended for use by children.

WHEN SHOULD YOU BE EXTRA CAREFUL WHEN USING EFUDIX CREAM?

Make sure your doctor knows if you are using any other medicines you apply to the areas of skin being treated (e.g. creams and ointments), including ones bought by yourself without a prescription.

HOW SHOULD EFUDIX CREAM BE USED?

• Always use Efudix Cream as your doctor tells you to. It must only be used on the skin.
• Be careful if applying Efudix Cream around your eyelids, nose and lips and avoid any contact with the eyes or mouth.Wash your hands thoroughly after use.
• If somebody else is helping you to apply the cream, they should take precautions to avoid cream being absorbed through their skin. It is recommended that they should wear disposable surgical gloves, remove these after use and wash their hands thoroughly. It is not necessary for you to wear gloves as the intended treatment results in some of the cream being absorbed.
• The cream should be applied in a thin layer to the affected area once or twice daily or as your doctor advises. The total area of skin treated at any one time should not be more than 23x23 cm (500 cm2) or 9x9 inches.
• Your doctor should tell you if you need to apply a dressing to the treated skin.
• You will normally need to use the cream for at least three to four weeks.Your skin may appear to be worse after you start the treatment.This is to be expected and you should continue to apply the cream as directed. If your skin becomes much worse, or if you are worried, consult your doctor. After stopping treatment you may find that your skin takes one to two months to heal completely.
• If the cream is swallowed or someone else accidentally uses it, contact your doctor, pharmacist or nearest hospital straight away.
• If you miss a dose, apply it 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.
• Do not change the prescribed dose yourself. If you think the effect of your medicine is too weak or strong, talk to your doctor.

WHAT ARE THE POSSIBLE UNWANTED EFFECTS OF EFUDIX CREAM?

In addition to the beneficial effects of Efudix Cream it is possible that unwanted effects will occur during treatment even when it is used as directed.

The cream may sometimes cause redness and discomfort in the affected skin and surrounding healthy skin and skin allergy may develop. Occasionally sores will develop and you may feel some discomfort. Rarely, the sores are round, red and painful. If you are suffering severe discomfort, your doctor may be able to help.

Whilst using Efudix your skin may become more sensitive to sunlight.To prevent this you should try to stay out of direct sunlight as much as possible whilst using the cream and do not use a sunlamp or sunbed.

If you are concerned about these or any other unwanted effects, talk to your doctor.

HOW SHOULD EFUDIX CREAM BE STORED?

• Keep this medicine out of reach and sight of children.
• Do not store above 30°C.
• This medicine should not be used after the date (EXP) printed on the pack. Return any leftover medicine to your pharmacist who will arrange for environment-friendly disposal. Only keep it if your doctor tells you to.
• Remember this medicine is for you. Only a doctor can prescribe it for you. Never give it to others. It may harm them even if their symptoms are the same as yours.