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FLOROURACIL 5% W/W CREAM

Active substance(s): FLUOROURACIL

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Efudix® 5% w/w Cream

2586
04.04.14[2]

(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.
Your medicine will be referred to as Efudix Cream throughout the following
leaflet.

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.
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.

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

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

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.

If you swallow some cream contact your doctor, pharmacist or go to your
nearest hospital straight away.

Important Information about How Efudix Cream Works
Efudix Cream destroys cancerous and pre-cancerous cells, while having
little effect on normal cells.
When you use Efudix Cream 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 Cream 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 Cream 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 Cream and it 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.
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.

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 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 Cream
- 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 Cream
is described in Section 1, under “How Efudix Cream 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.
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 EFUDIX CREAM
- Store Efudix Cream out of the sight and reach of children.
- Do not store Efudix Cream above 30°C.
- Once opened, use within 90 days.
- 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.
- Any unused Efudix cream should be returned to your pharmacist for safe
disposal.
- 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
Active substance: Fluorouracil (at a 5% w/w).
Other ingredients: Stearyl alcohol, white soft paraffin, polysorbate 60,
propylene glycol (E1520), methyl parahydroxybenzoate (E218), propyl
parahydroxybenzoate (E216) and purified water.
What Efudix Cream looks like and contents of the pack
- Efudix Cream is a smooth, white, opaque cream.
- It is supplied in tubes of 40 g.
Manufacturer and Product Licence Holder
Manufactured by ICN Polfa Rzeszow S.A., ul. Przemyslowa 2,
35-959 Rzeszow, Poland. Procured from within the EU by Product Licence
holder: Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex
HA1 1XD. Repackaged by Servipharm Ltd.
POM

PL 20636/2586

Leaflet issue and revision date: (Ref) 04.04.14[2]
Efudix is a trademark of Meda AB.

Fluorouracil 5% w/w Cream

2586
04.04.14[2]

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.
Your medicine will be referred to as Fluorouracil Cream throughout the
following leaflet.
In this leaflet:
1. What Fluorouracil Cream is and what it is used for
2. Before you use Fluorouracil Cream
3. How to use Fluorouracil Cream
4. Possible side effects
5. How to store Fluorouracil Cream
6. Further information
1. WHAT FLUOROURACIL CREAM IS AND WHAT IT IS USED FOR
Fluorouracil 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 Fluorouracil Cream Works
Fluorouracil Cream destroys cancerous and pre-cancerous cells, while
having little effect on normal cells.
When you use Fluorouracil Cream 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 Cream 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 Cream 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 CREAM
Do not use Fluorouracil 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.
Fluorouracil Cream is not for use in anyone under 18 years of age.
Take special care with Fluorouracil 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 Fluorouracil
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).

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 Cream.
Pregnancy and breast-feeding
Do not use Fluorouracil 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 Fluorouracil
Cream
Fluorouracil 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 Fluorouracil Cream if you are allergic to any of its ingredients.
3. HOW TO USE FLUOROURACIL CREAM
Always use Fluorouracil 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 Fluorouracil Cream
- Only use Fluorouracil 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 Fluorouracil 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, Fluorouracil Cream can cause side effects, although not
everybody gets them. The usual response to treatment with Fluorouracil
Cream is described in Section 1, under “How Fluorouracil Cream 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.

Sunlight may increase the effects of Fluorouracil Cream and it 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.

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.

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.

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 CREAM
- Store Fluorouracil Cream out of the sight and reach of children.
- Do not store Fluorouracil Cream above 30°C.
- Once opened, use within 90 days.
- Do not use Fluorouracil 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.
- Any unused Fluorouracil cream should be returned to your pharmacist for
safe disposal.
- 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 Fluorouracil Cream contains
Active substance: Fluorouracil (at a 5% w/w).
Other ingredients: Stearyl alcohol, white soft paraffin, polysorbate 60,
propylene glycol (E1520), methyl parahydroxybenzoate (E218), propyl
parahydroxybenzoate (E216) and purified water.
What Fluorouracil Cream looks like and contents of the pack
- Fluorouracil Cream is a smooth, white, opaque cream.
- It is supplied in tubes of 40 g.
Manufacturer and Product Licence Holder
Manufactured by ICN Polfa Rzeszow S.A., ul. Przemyslowa 2,
35-959 Rzeszow, Poland. Procured from within the EU by Product Licence
holder: Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex
HA1 1XD. Repackaged by Servipharm Ltd.
POM

PL 20636/2586

Leaflet issue and revision date: (Ref) 04.04.14[2]

Expand view ⇕

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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