Fluorouracil 5% W/W Cream
PACKAGE LEAFLET: INFORMATION FOR THE USER
Efudix 5%w/w cream
(fluorouracil)
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.
The name of your medicine is Efudix 5%w/w cream but will be referred to as Efudix throughout this leaflet.
In this leaflet:
1. What Efudix is and what it is used for
2. Before you use Efudix
3. How to use Efudix
4. Possible side effects
5. How to store Efudix
6. Further 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 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 Do not use Efudix 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 is not for use in anyone under 18 years of age.
Take special care with Efudix 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”).
• 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.
Pregnancy and breast-feeding
Do not use Efudix 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
Efudix 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
Always use Efudix 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 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
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 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 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
Keep out of the sight and reach of children.
Do not store above 25°C.
Do not refrigerate or freeze.
Once opened use within 3 months.
Do not use the cream after the expiry date which is stated on the carton and tube label after ‘Exp’. The expiry date refers to the last day of that month.
If the cream becomes discolured or show 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. This will help protect the environment.
6. FURTHER INFORMATION What Efudix contains
Each tube contains 40g of 5% fluorouracil.
The other ingredients are stearyl alcohol, white soft paraffin, polysorbate 60 (E435), propylene glycol (E1520), methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216) and purified water.
What Efudix looks like
Efudix is a white, opaque cream.
It is supplied in tubes containing 40g cream.
Manufactured by: ICN Polfa Rzeszow S.A., ul. Przemystowa 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 18799/2410
Leaflet date: 27.07.2016 |pqm I
Efudix is a registered trademark of Meda Pharmaceuticals.
PACKAGE LEAFLET: INFORMATION FOR THE USER
Fluorouracil 5%w/w cream
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.
The name of your medicine is Fluorouracil 5%w/w cream but will be referred to as Fluorouracil throughout this leaflet.
In this leaflet:
1. What Fluorouracil is and what it is used for
2. Before you use Fluorouracil
3. How to use Fluorouracil
4. Possible side effects
5. How to store Fluorouracil
6. Further 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 precancerous 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. BEFORE YOU USE FLUOROURACIL Do not use Fluorouracil 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.
Fluorouracil is not for use in anyone under 18 years of age.
Take special care with Fluorouracil 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 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.
• have reduced activity/deficiency of the enzyme DPD (dihydropyrimidine dehydrogenase).
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.
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 Fluorouracil.
Pregnancy and breast-feeding
Do not use Fluorouracil 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 Fluorouracil
Fluorouracil 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 Fluorouracil if you are allergic to any of its ingredients.
3. HOW TO USE FLUOROURACIL
Always use Fluorouracil 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 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 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 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 the missed 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”.
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/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE FLUOROURACIL
Keep out of the sight and reach of children.
Do not store above 25°C.
Do not refrigerate or freeze.
Once opened use within 3 months.
Do not use the cream after the expiry date which is stated on the carton and tube label after ‘Exp’. The expiry date refers to the last day of that month.
If the cream becomes discoloured 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. This will help protect the environment.
6. FURTHER INFORMATION What Fluorouracil contains
Each tube contains 40g of 5% fluorouracil.
The other ingredients are stearyl alcohol, white soft paraffin, polysorbate 60 (E435), propylene glycol (E1520), methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216) and purified water.
What Fluorouracil looks like
Fluorouracil is a white, opaque cream.
It is supplied in tubes containing 40g cream.
Manufactured by: ICN Polfa Rzeszow S.A., ul. Przemystowa 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. [pqmI
Fluorouracil 5%w/w cream PL 18799/2410
Leaflet date: 27.07.2016