Efudix Cream (Fluorouracil) used
Efudix Cream is a topical treatment for several types of skin lesion both pre-malignant (lesions that have not become cancerous) and malignant (lesions that have become cancerous). Efudix Cream is used to treat actinic keratosis (also known as solar keratosis), a pre-malignant skin lesion characterised by thick raised scaly patches of skin caused by too much exposure to the sun. This is usually found in fair-skinned people on exposed parts of the body; when associated with aging this is known as senile keratosis. Keratosis refers to the overproduction of keratin, which is a fibrous structural protein in the outer skin layers (epidermis) and can also be caused by arsenic, a natural mineral used in industrial or agricultural compounds (arsenical keratosis); this form of keratosis can be found on the palms of the hands of soles of the feet. If left untreated keratosis can develop into squamous cell carcinoma (SCC), which is a non-melanoma type of malignant skin cancer. Efudix Cream is also used to treat basal cell carcinoma (BCC), which is the most common form of skin cancer and although it is malignant (invasive) it is not usually harmful. BCC develops in the basal layer of the epidermis, is found mainly on the head, neck and other exposed areas in skin of fair-skinned people and is caused by excess sun exposure or repeated sunburn. BCC grows slowly and varies in appearance from small translucent nodules to larger brown, reddened or thickened patches of skin and can form ulcers and bleed easily. Keratoacanthoma is a form of skin cancer that develops from a hair follicle and can be triggered by sun exposure or a minor injury; it appears as a dome-shaped nodule on the skin. These lesions respond to treatment with Efudix Cream, whereas SCC does not, because although it develops from the epidermis it grows down into the deeper skin layers (dermis). Efudix Cream is only used for SCC when no other treatment is possible. Efudix Cream is also used to treat Bowen’s disease, which is thought to be an early form of SCC and develops from the epithelium beneath the epidermis. It can occur anywhere on the skin, where it appears as a patch of reddened crusty and scaly skin.
Efudix Cream (Fluorouracil) work
Efudix Cream contains fluorouracil, which is an antimetabolite that blocks the use of another metabolite used in a normal metabolic process. In this case fluorouracil in Efudix Cream is a pyrimidine analogue. Pyrimidine are precursors for the nucleotides that form the backbone of DNA and RNA. Fluorouracil in Efudix Cream is converted into several active cytotoxic metabolites. One of these metabolites ( 5-fluoroxyuridine monophosphate) becomes incorporated into RNA instead of the nucleotide uracil and this blocks the processing of RNA within the cell. Another metabolite inhibits the enzyme thymidylate synthase, which is needed for the synthesis of thymidine, a nucleotide used for DNA replication. The action of fluorouracil in Efudix Cream inhibits cell growth and eventually leads to cell death. Fluorouracil in Efudix Cream is most effective on cells that are growing rapidly, such as neoplastic cells (abnormal growth of pre-malignant and malignant cells) because they take up fluorouracil at a faster rate than normal cells. Efudix Cream is a topical treatment that is absorbed into the skin but small amounts do get into the blood stream and may have some systemic effects.
PACKAGE LEAFLET: INFORMATION FOR THE USER
Efudix 5% 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.
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 23x23cm (9x9 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/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 reach and sight of children.
- Do not store Efudix Cream above 30°C.
- For 20 g and 40 g tubes: 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% concentration).
Other ingredients: Stearyl alcohol, white soft paraffin, polysorbate 60, propylene glycol, E218 (methyl parahydroxybenzoate), E216 (propyl parahydroxybenzoate), purified water.
What Efudix Cream looks like and contents of the pack
- Efudix is a white, opaque cream.
- It is supplied in tubes of 20 g and 40 g. Not all pack sizes may be marketed.
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