DERMOVATE OINTMENT
Active substance: CLOBETASOL PROPIONATE
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10000000050322
Package Leaflet: Information for the User
Dermovate Ointment
clobetasol propionate
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 any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1 What Dermovate is and what it is used for 2 Before you use Dermovate 3 How to use Dermovate 4 Possible side effects 5 How to store Dermovate 6 Further information Pregnancy and breast-feeding Talk to your doctor or pharmacist before using this medicine if you are pregnant, might become pregnant or are breast-feeding.
3 How to use Dermovate
Always use Dermovate exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Using this medicine You usually apply a thin layer of Dermovate 1 or 2 times a day. This may be reduced as your skin begins to get better, or stopped when it is better. This ointment is for use on your skin only. Do not use on large areas of the body for a long time (such as every day for many weeks or months).If you need treatment for a long time, your doctor may decide you need to use a milder cream or ointment. The germs that cause infections like warm and moist conditions under dressings so always clean the skin before a fresh dressing is put on. If you are applying the ointment on someone else make sure you wash your hands after use or wear disposable plastic gloves. If your skin problem does not improve in 2 to 4 weeks, talk to your doctor. Guidance on how to apply the ointment 1 Wash your hands. 2 Gently rub the correct amount of ointment into the skin until it has all disappeared. You can measure how much Dermovate to use with your fingertip. This picture shows one fingertip unit.
1 What Dermovate is and what it is used for
Dermovate contains a medicine called clobetasol propionate. It belongs to a group of medicines called steroids. It helps to reduce swelling and irritation. Dermovate is used to help reduce the redness and itchiness of certain skin problems. These skin problems include eczema, psoriasis and dermatitis that have not responded to milder steroid creams or ointments.
2 Before you use Dermovate
Do not use Dermovate: if you are allergic (hypersensitive) to clobetasol propionate or any of the other ingredients of Dermovate (listed in Section 6) on a child under 1 years old to treat any of the following skin problems, it could make them worse: - acne - severe flushing of skin on and around your nose (rosacea) - spotty red rash around your mouth (perioral dermatitis) - itching around your back passage or private parts - unless your doctor has told you to do so - viral infections, such as cold sores, herpes or chicken pox - fungal infections, such as ringworm, athletes foot or thrush - skin blisters or sores that are caused by an infection. Do not use if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before using Dermovate. Take special care with Dermovate Check with your doctor or pharmacist before using your medicine if: you are applying the ointment under an airtight dressing, including a childs nappy. These dressings make it easier for the active ingredient to pass through the skin. It is possible to accidentally end up using too much ointment. you have psoriasis, your doctor will want to see you more often. If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using this medicine.
3 Unless you are meant to apply the ointment to your hands as a part of the treatment, wash them again after using the ointment. For an adult You should find that: two fingertips of ointment will cover both hands or one foot three fingertips of ointment will cover one arm six fingertips of ointment will cover one leg fourteen fingertips of ointment will cover the front and back of the body. Do not worry if you find you need a little more or a little less than this. It is only a rough guide.
Weight gain, rounding of the face and high blood pressure. These are more likely to happen in infants and children. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5 How to store Dermovate
Keep out of the reach and sight of children. Do not use Dermovate after the expiry date on the tube or carton (Exp). The expiry date refers to the last day of that month. Do not store above 30C. 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.
For a child Do not use it on children under 1 years of age. The smaller the child the less you will need to use. A child of 4 years needs about a third of the adult amount. A course of treatment for a child should not normally last more than 5 days - unless your doctor has told you to use it for longer. The doctor may want to see the child every week, whilst using the ointment. If you have psoriasis If you have thick patches of psoriasis on your elbows or knees, your doctor may suggest applying the ointment under an airtight dressing. It will only be at night to help the ointment to start working. After a short period of time you will then apply the ointment as normal. If you apply Dermovate to your face You should only apply the ointment to your face if your doctor tells you to. It should not be used for more than 5 days, as the skin on your face thins easily. Do not let the ointment get into your eyes. If it does, wash it out with plenty of water. If you use more Dermovate than you should If, by mistake on a few occasions you use more than you should, do not worry. If you apply a lot or if a lot is accidentally swallowed, it could make you ill. Talk to your doctor or go to hospital as soon as possible. If you forget to use Dermovate If you forget to apply your ointment, apply it as soon as you remember. If it is close to the time you are next meant to apply it, wait until this time. If you stop using Dermovate If you use Dermovate regularly make sure you talk to your doctor before you stop using it. If you have any further questions on the use of this product, ask your doctor or pharmacist.
6 Further information
What Dermovate contains The active ingredient is clobetasol propionate. Each 1 g contains 0.5 mg of clobetasol propionate (0.05% w/w). The other ingredients are propylene glycol, sorbitan sesquioleate and white soft paraffin. What Dermovate looks like and contents of the pack Within each carton is a tube with a plastic screw cap, which contains either 30 or 100 g of ointment. Marketing Authorisation Holder and Manufacturer Product licence held by GlaxoSmithKline UK, Stockley Park West, Uxbridge, Middlesex UB11 1BT Manufactured by Glaxo Wellcome Operations, Barnard Castle, Durham DL12 8DT More Information If you have any questions or are not sure about anything, ask your doctor or pharmacist who will advise you. Other sources of information are: National Eczema Society, Hill House, Highgate Hill, London N19 5NA The Psoriasis Association, 2 Queensbridge, Northampton, NN4 7BF You may also be able to find out more from books in public libraries. Other formats To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:
0800 198 5000 (UK Only)
4 Possible side effects
Like all medicines, Dermovate can cause side effects, although not everybody gets them. Stop using Dermovate and tell your doctor as soon as possible if: you find that your skin problem gets worse or becomes swollen during treatment. You may be allergic to the ointment, have an infection or need other treatment. Other side effects you may notice when using Dermovate include: A feeling of burning, irritation or itching where the ointment is applied. If you have psoriasis you may get raised bumps with pus under the skin. This can happen during or after the treatment and is known as pustular psoriasis. Side effects if you use Dermovate for a long time, or you use a lot each time you apply it, or you apply it under an airtight dressing or a nappy: Stretch marks may develop. Veins under the surface of your skin may become more noticeable. Increased hair growth and changes in skin colour. Thinning of your skin that may also damage more easily.
Please be ready to give the following information: Product name Dermovate Ointment Reference number 10949/0028 This is a service provided by the Royal National Institute of Blind People. Leaflet date: November 2007 Dermovate is a registered trademark of the GlaxoSmithKline group of companies 2007 GlaxoSmithKline group of companies
10000000050322
Package Leaflet: Information for the User
Dermovate Ointment
clobetasol propionate
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 any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1 What Dermovate is and what it is used for 2 Before you use Dermovate 3 How to use Dermovate 4 Possible side effects 5 How to store Dermovate 6 Further information Pregnancy and breast-feeding Talk to your doctor or pharmacist before using this medicine if you are pregnant, might become pregnant or are breast-feeding.
3 How to use Dermovate
Always use Dermovate exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Using this medicine You usually apply a thin layer of Dermovate 1 or 2 times a day. This may be reduced as your skin begins to get better, or stopped when it is better. This ointment is for use on your skin only. Do not use on large areas of the body for a long time (such as every day for many weeks or months).If you need treatment for a long time, your doctor may decide you need to use a milder cream or ointment. The germs that cause infections like warm and moist conditions under dressings so always clean the skin before a fresh dressing is put on. If you are applying the ointment on someone else make sure you wash your hands after use or wear disposable plastic gloves. If your skin problem does not improve in 2 to 4 weeks, talk to your doctor. Guidance on how to apply the ointment 1 Wash your hands. 2 Gently rub the correct amount of ointment into the skin until it has all disappeared. You can measure how much Dermovate to use with your fingertip. This picture shows one fingertip unit.
1 What Dermovate is and what it is used for
Dermovate contains a medicine called clobetasol propionate. It belongs to a group of medicines called steroids. It helps to reduce swelling and irritation. Dermovate is used to help reduce the redness and itchiness of certain skin problems. These skin problems include eczema, psoriasis and dermatitis that have not responded to milder steroid creams or ointments.
2 Before you use Dermovate
Do not use Dermovate: if you are allergic (hypersensitive) to clobetasol propionate or any of the other ingredients of Dermovate (listed in Section 6) on a child under 1 years old to treat any of the following skin problems, it could make them worse: - acne - severe flushing of skin on and around your nose (rosacea) - spotty red rash around your mouth (perioral dermatitis) - itching around your back passage or private parts - unless your doctor has told you to do so - viral infections, such as cold sores, herpes or chicken pox - fungal infections, such as ringworm, athletes foot or thrush - skin blisters or sores that are caused by an infection. Do not use if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before using Dermovate. Take special care with Dermovate Check with your doctor or pharmacist before using your medicine if: you are applying the ointment under an airtight dressing, including a childs nappy. These dressings make it easier for the active ingredient to pass through the skin. It is possible to accidentally end up using too much ointment. you have psoriasis, your doctor will want to see you more often. If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using this medicine.
3 Unless you are meant to apply the ointment to your hands as a part of the treatment, wash them again after using the ointment. For an adult You should find that: two fingertips of ointment will cover both hands or one foot three fingertips of ointment will cover one arm six fingertips of ointment will cover one leg fourteen fingertips of ointment will cover the front and back of the body. Do not worry if you find you need a little more or a little less than this. It is only a rough guide.
Weight gain, rounding of the face and high blood pressure. These are more likely to happen in infants and children. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5 How to store Dermovate
Keep out of the reach and sight of children. Do not use Dermovate after the expiry date on the tube or carton (Exp). The expiry date refers to the last day of that month. Do not store above 30C. 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.
For a child Do not use it on children under 1 years of age. The smaller the child the less you will need to use. A child of 4 years needs about a third of the adult amount. A course of treatment for a child should not normally last more than 5 days - unless your doctor has told you to use it for longer. The doctor may want to see the child every week, whilst using the ointment. If you have psoriasis If you have thick patches of psoriasis on your elbows or knees, your doctor may suggest applying the ointment under an airtight dressing. It will only be at night to help the ointment to start working. After a short period of time you will then apply the ointment as normal. If you apply Dermovate to your face You should only apply the ointment to your face if your doctor tells you to. It should not be used for more than 5 days, as the skin on your face thins easily. Do not let the ointment get into your eyes. If it does, wash it out with plenty of water. If you use more Dermovate than you should If, by mistake on a few occasions you use more than you should, do not worry. If you apply a lot or if a lot is accidentally swallowed, it could make you ill. Talk to your doctor or go to hospital as soon as possible. If you forget to use Dermovate If you forget to apply your ointment, apply it as soon as you remember. If it is close to the time you are next meant to apply it, wait until this time. If you stop using Dermovate If you use Dermovate regularly make sure you talk to your doctor before you stop using it. If you have any further questions on the use of this product, ask your doctor or pharmacist.
6 Further information
What Dermovate contains The active ingredient is clobetasol propionate. Each 1 g contains 0.5 mg of clobetasol propionate (0.05% w/w). The other ingredients are propylene glycol, sorbitan sesquioleate and white soft paraffin. What Dermovate looks like and contents of the pack Within each carton is a tube with a plastic screw cap, which contains either 30 or 100 g of ointment. Marketing Authorisation Holder and Manufacturer Product licence held by GlaxoSmithKline UK, Stockley Park West, Uxbridge, Middlesex UB11 1BT Manufactured by Glaxo Wellcome Operations, Barnard Castle, Durham DL12 8DT More Information If you have any questions or are not sure about anything, ask your doctor or pharmacist who will advise you. Other sources of information are: National Eczema Society, Hill House, Highgate Hill, London N19 5NA The Psoriasis Association, 2 Queensbridge, Northampton, NN4 7BF You may also be able to find out more from books in public libraries. Other formats To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:
0800 198 5000 (UK Only)
4 Possible side effects
Like all medicines, Dermovate can cause side effects, although not everybody gets them. Stop using Dermovate and tell your doctor as soon as possible if: you find that your skin problem gets worse or becomes swollen during treatment. You may be allergic to the ointment, have an infection or need other treatment. Other side effects you may notice when using Dermovate include: A feeling of burning, irritation or itching where the ointment is applied. If you have psoriasis you may get raised bumps with pus under the skin. This can happen during or after the treatment and is known as pustular psoriasis. Side effects if you use Dermovate for a long time, or you use a lot each time you apply it, or you apply it under an airtight dressing or a nappy: Stretch marks may develop. Veins under the surface of your skin may become more noticeable. Increased hair growth and changes in skin colour. Thinning of your skin that may also damage more easily.
Please be ready to give the following information: Product name Dermovate Ointment Reference number 10949/0028 This is a service provided by the Royal National Institute of Blind People. Leaflet date: November 2007 Dermovate is a registered trademark of the GlaxoSmithKline group of companies 2007 GlaxoSmithKline group of companies
10000000050322
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.
