FLUOROURACIL 5% W/W CREAM, EFUDIX 5% W/W CREAM - patient leaflet, side effects, dosage

Efudix

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.

The name of your medicine is Efudix 5%w/w cream but will be referred to as Efudix throughout this leaflet.

What is in this leaflet

• 1. What Efudix is and what it is used for

• 2. What you need to know before you use Efudix

• 3. How to use Efudix

• 4. Possible side effects

• 5. How to store Efudix

• 6. Contents of the pack and other information

1. what efudix is and what it is used for

Efudix 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 anticancer 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

Do not use Efudix:

• 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.

Warnings and precautions

Talk to your doctor or pharmacist before taking Efudix:

• if you know that you have reduced or no activity of the enzyme dihydropyrimidine dehydrogenase (DPD) (partial or complete DPD deficiency).
• 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’).
• 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.

Do not smoke or go near naked flames – risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.

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 is not for use in anyone under 18 years of age.

Other medicines and Efudix

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.

Pregnancy, breast-feeding and fertility

Do not use Efudix 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.

If you become pregnant during treatment inform your doctor immediately and make use of genetic counselling.

Do not use Efudix and tell your doctor if you are breastfeeding. If use during breast-feeding is absolutely necessary, breast-feeding must be discontinued.

The use of Efudix may impair female and male fertility. Efudix 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 contains

• Methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216): May cause allergic reactions (possibly delayed).
• Propylene glycol: May cause skin irritation. Because this medicine contains propylene glycol, do not use it on open wounds or large areas of broken or damaged skin (such as burns) without checking with your doctor or pharmacist.
• Stearyl alcohol: May cause local skin irritations (e.g. contact dermatitis, which is an inflammation of the skin).

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

3. how to use efudix

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 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 × 23cm (9 × 9 inches) at any one time. This area is approximately the size of a dinner plate.

If you forget to use Efudix

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 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.

• – Rash on areas other than where the cream was applied

• – Hair loss

Not known (frequency cannot be estimated from the available data)

• – Painful and/or watering eyes

• – Taste disturbance

• – Headache, dizziness, nausea

• – Bleeding at the application site.

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: or search for MHRA Yellow Card in the Google Play or Apple App Store.

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

5. how to store efudix

Keep out of the sight and reach of children.

Do not store above 30°C.

Once opened use within 90 days.

Do not use the cream after the expiry date which is stated on the carton and tube labels after ‘Exp’. The expiry date refers to the last day of that month.

If the cream becomes discolored or shows any signs of deterioration, seek the advice of your pharmacist. Medicines should 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. contents of the pack and other information what efudix contains

The active ingredient in Efudix is fluorouracil.

Each tube contains 40g of cream containing 5%w/w fluorouracil.

The other ingredients are stearyl alcohol, white soft paraffin, polysorbate 60, propylene glycol (E1520), methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216) and purified water.

What Efudix looks like and contents of the pack

Efudix is a white, opaque cream.

Efudix is supplied in tubes containing 40g cream.

Manufactured by: ICN Polfa Rzeszow S.A., ul. Przemyslowa 2, 35–959 Rzeszow, Poland.

Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.

Efudix ® 5%w/w cream; PL 18799/3163

Leaflet date: 27.10.2020 LPOMJ

Efudix is a registered trademark of Meda AB.

Blind or partially sighted?

Is this leaflet hard to see or read?

Call 0208 515 3763 to obtain the leaflet in a format suitable for you.

Package leaflet: Information for the user

Fluorouracil 5%w/w cream

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.

The name of your medicine is Fluorouracil 5%w/w cream but will be referred to as Fluorouracil throughout this leaflet.

What is in this leaflet

• 1. What Fluorouracil is and what it is used for

• 2. What you need to know before you use Fluorouracil

• 3. How to use Fluorouracil

• 4. Possible side effects

• 5. How to store Fluorouracil

• 6. Contents of the pack and other information

1. what fluorouracil is and what it is used for

Fluorouracil 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 Fluorouracil Works Fluorouracil destroys cancerous and pre-cancerous cells, while having little effect on normal cells.

When you use Fluorouracil 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 Fluorouracil 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.

Fluorouracil 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 fluorouracil

Do not use Fluorouracil:

• 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.

Warnings and precautions

Talk to your doctor or pharmacist before taking Fluorouracil :

• if you know that you have reduced or no activity of the enzyme dihydropyrimidine dehydrogenase (DPD) (partial or complete DPD deficiency).
• are applying this cream around your eyelids, nose or lips, and avoid contact with the eyes or mouth (see section 3, ‘How to use Fluorouracil’).
• 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.

Do not smoke or go near naked flames – risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.

Sunlight may increase the effects of Fluorouracil. 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

Fluorouracil is not for use in anyone under 18 years of age.

Other medicines and Fluorouracil

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 Fluorouracil.

Pregnancy, breast-feeding and fertility

Do not use Fluorouracil and tell your doctor if you are pregnant, think you might be pregnant. An effective method of contraception must be used during treatment with Fluorouracil.

If you become pregnant during treatment inform your doctor immediately and make use of genetic counselling.

Do not use Fluorouracil and tell your doctor if you are breast-feeding. If use during breast-feeding is absolutely necessary, breast-feeding must be discontinued.

The use of Fluorouracil may impair female and male fertility. Fluorouracil 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.

Fluorouracil contains

• Methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216): May cause allergic reactions (possibly delayed).
• Propylene glycol: May cause skin irritation. Because this medicine contains propylene glycol, do not use it on open wounds or large areas of broken or damaged skin (such as burns) without checking with your doctor or pharmacist.
• Stearyl alcohol: May cause local skin irritations (e.g. contact dermatitis, which is an inflammation of the skin).

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

3. how to use fluorouracil

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 Fluorouracil

• Only use Fluorouracil 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 × 23cm (9 × 9 inches) at any one time. This area is approximately the size of a dinner plate.

If you forget to use Fluorouracil

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, Fluorouracil can cause side effects, although not everybody gets them. The usual response to treatment with Fluorouracil is described in Section 1, under ‘How Fluorouracil 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.

• – Rash on areas other than where the cream was applied

• – Hair loss

Not known (frequency cannot be estimated from the available data)

• – Painful and/or watering eyes

• – Taste disturbance

• – Headache, dizziness, nausea

• – Bleeding at the application site.

5. how to store fluorouracil

Keep out of the sight and reach of children.

Do not store above 30°C.

Once opened use within 90 days.

Do not use the cream after the expiry date which is stated on the carton and tube labels after ‘Exp’. The expiry date refers to the last day of that month.

If the cream becomes discolored or shows any signs of deterioration, seek the advice of your pharmacist. Medicines should 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. contents of the pack and other information what fluorouracil contains

The active ingredient is fluorouracil.

Each tube contains 40g of cream containing 5%w/w fluorouracil.

The other ingredients are stearyl alcohol, white soft paraffin, polysorbate 60, propylene glycol (E1520), methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216) and purified water.

What Fluorouracil looks like and contents of the pack

Fluorouracil is a white, opaque cream.

Fluorouracil is supplied in tubes containing 40g cream.

Manufactured by: ICN Polfa Rzeszow S.A., ul. Przemyslowa 2, 35–959 Rzeszow, Poland.

Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.

Fluorouracil 5%w/w cream; PL 18799/3163

Leaflet date: 27.10.2020 | POM |

Blind or partially sighted?

Is this leaflet hard to see or read?

Call 0208 515 3763 to obtain the leaflet in a format suitable for you.