EFUDIX CREAM
Active substance: FLUOROURACIL
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Efudix 5% Cream
Fluorouracil 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 opencuts 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.is 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 asunlamp 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. 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 medicinesmayincrease 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. Do not use Efudix if you are allergic to any of its ingredients. 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 thesame as yours. If you experience any side effect andthis becomesserious, 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) andsome simple skin cancers. The active ingredient fluorouracil, belongs to agroup 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 followedby 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.
3. HOW TO USE EFUDIX CREAM
Always use Efudix Cream exactly as your doctor has told you. You must check with your doctor orpharmacist 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.
Store Efudix Cream out of the reach and sightof children. If any of the following occur, wash thecreamoff Do not store Efudix Cream above 30C. usingwater, then contact your doctor, For 20 g and 40 g tubes: Once opened, use pharmacist or go to your nearest hospital within 90 days. straight away: Do not use Efudix Cream after the expiry You get this cream in your eyes, nose or mouth. datewhich is stated on the tube and the outer Someone else accidentally uses this cream. carton after EXP. The expiry date refers to thelast day of that month. How to apply Efudix Any unused Efudix cream should be returned Only use Efudix Cream on the skin and to your pharmacist for safe disposal. avoidcontact with the eyes and mouth. Medicines must not be disposed of via Apply athin layer of the cream to the wastewater or household waste. Ask your affectedarea as instructed by your doctor. pharmacist how to dispose of medicines no It is very important that you do not use too longer required. These measures will help to much cream and do not apply the cream protect the environment. onopen cuts. This may lead to some cream being absorbed into the blood and, very 6. FURTHER INFORMATION rarely,this can cause side effects. What Efudix Cream contains The cream is usually used once or twice aday for at least three to four weeks. Active substance: Fluorouracil Wash your hands thoroughly after using this (at a5% concentration). cream. Other ingredients: Stearyl alcohol, white soft Your doctor will tell you if you need to apply paraffin, polysorbate60, adressing to the treated skin. propylene glycol, E218 Never treat an area of skin larger than (methyl parahydroxy 23x23cm (9x9 inches) at any one time. This benzoate), E216 (propyl area is approximately the size of adinner parahydroxybenzoate), plate. purified water. If you forget to use Efudix Cream What Efudix Cream looks like and contents of If you miss adose, apply the cream as soon as the pack possible. However, if it is nearly time for your Efudix is awhite, opaque cream. next dose, skip the missed dose and carry on as It is supplied in tubes of 20 g and 40 g. before. Do not apply adouble dose to make up Notallpack sizes may be marketed. for the missed dose. Marketing Authorisation Holder 4. POSSIBLE SIDE EFFECTS Meda Pharmaceuticals Ltd., Skyway House, Parsonage Road, Takeley, BishopsStortford, Like all medicines, Efudix Cream can causeside CM22 6PU, UK. effects, although not everybody gets them.The usual response to treatment with Efudix is Manufacturer responsible for batch release described in Section 1, under How Efudix ICN Polfa Rzeszw S.A., ul. Przemysowa 2, works. 35-959 Rzeszw, Poland The unwanted effects are: For any information about this medicine, please Relating to the skin and subcutaneous tissue. contact the Marketing Authorisation Holder. Itching, redness, burning sensation, severe This leaflet was last revised in February 2011. peeling, intense swelling or inflammation, ulceration, blistering, irritation, pain and rash. These are generally asevere response to treatment and usually occur in the areas of the skin where the cream has been applied. General side effects: Sores which are red, round and painful. Rash on areas other than where the cream wasapplied. Other side effects may occur if you use too much cream or if you apply the cream to opencuts. These side effects are listed below. You must tell your doctor IMMEDIATELY ifyou 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. Consult your doctor or pharmacist if you are concerned about any of the above effects or if you notice any additional side effects not listedin this leaflet.
If you swallow some cream contact your doctor, pharmacist or go to your nearest hospital straight away.
5. HOW TO STORE EFUDIX CREAM
Efudix 5% Cream
Fluorouracil 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 opencuts 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.is 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 asunlamp 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. 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 medicinesmayincrease 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. Do not use Efudix if you are allergic to any of its ingredients. 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 thesame as yours. If you experience any side effect andthis becomesserious, 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) andsome simple skin cancers. The active ingredient fluorouracil, belongs to agroup 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 followedby 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.
3. HOW TO USE EFUDIX CREAM
Always use Efudix Cream exactly as your doctor has told you. You must check with your doctor orpharmacist 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.
Store Efudix Cream out of the reach and sightof children. If any of the following occur, wash thecreamoff Do not store Efudix Cream above 30C. usingwater, then contact your doctor, For 20 g and 40 g tubes: Once opened, use pharmacist or go to your nearest hospital within 90 days. straight away: Do not use Efudix Cream after the expiry You get this cream in your eyes, nose or mouth. datewhich is stated on the tube and the outer Someone else accidentally uses this cream. carton after EXP. The expiry date refers to thelast day of that month. How to apply Efudix Any unused Efudix cream should be returned Only use Efudix Cream on the skin and to your pharmacist for safe disposal. avoidcontact with the eyes and mouth. Medicines must not be disposed of via Apply athin layer of the cream to the wastewater or household waste. Ask your affectedarea as instructed by your doctor. pharmacist how to dispose of medicines no It is very important that you do not use too longer required. These measures will help to much cream and do not apply the cream protect the environment. onopen cuts. This may lead to some cream being absorbed into the blood and, very 6. FURTHER INFORMATION rarely,this can cause side effects. What Efudix Cream contains The cream is usually used once or twice aday for at least three to four weeks. Active substance: Fluorouracil Wash your hands thoroughly after using this (at a5% concentration). cream. Other ingredients: Stearyl alcohol, white soft Your doctor will tell you if you need to apply paraffin, polysorbate60, adressing to the treated skin. propylene glycol, E218 Never treat an area of skin larger than (methyl parahydroxy 23x23cm (9x9 inches) at any one time. This benzoate), E216 (propyl area is approximately the size of adinner parahydroxybenzoate), plate. purified water. If you forget to use Efudix Cream What Efudix Cream looks like and contents of If you miss adose, apply the cream as soon as the pack possible. However, if it is nearly time for your Efudix is awhite, opaque cream. next dose, skip the missed dose and carry on as It is supplied in tubes of 20 g and 40 g. before. Do not apply adouble dose to make up Notallpack sizes may be marketed. for the missed dose. Marketing Authorisation Holder 4. POSSIBLE SIDE EFFECTS Meda Pharmaceuticals Ltd., Skyway House, Parsonage Road, Takeley, BishopsStortford, Like all medicines, Efudix Cream can causeside CM22 6PU, UK. effects, although not everybody gets them.The usual response to treatment with Efudix is Manufacturer responsible for batch release described in Section 1, under How Efudix ICN Polfa Rzeszw S.A., ul. Przemysowa 2, works. 35-959 Rzeszw, Poland The unwanted effects are: For any information about this medicine, please Relating to the skin and subcutaneous tissue. contact the Marketing Authorisation Holder. Itching, redness, burning sensation, severe This leaflet was last revised in February 2011. peeling, intense swelling or inflammation, ulceration, blistering, irritation, pain and rash. These are generally asevere response to treatment and usually occur in the areas of the skin where the cream has been applied. General side effects: Sores which are red, round and painful. Rash on areas other than where the cream wasapplied. Other side effects may occur if you use too much cream or if you apply the cream to opencuts. These side effects are listed below. You must tell your doctor IMMEDIATELY ifyou 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. Consult your doctor or pharmacist if you are concerned about any of the above effects or if you notice any additional side effects not listedin this leaflet.
If you swallow some cream contact your doctor, pharmacist or go to your nearest hospital straight away.
5. HOW TO STORE EFUDIX CREAM
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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
