DERMOVATE-NN OINTMENT
Active substance: NYSTATIN
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Dermovate-NN Ointment
clobetasol propionate, neomycin sulphate, nystatin
202624 101/L/m/3
Read all of this leaflet carefully before you start using this medicine.
iKeep this leaflet. You may need to read it again. iIf you have any further questions, ask your doctor or pharmacist. iThis 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. iIf any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What this medicine is and what it is used for 2. Before you use 3. How to use 4. Possible side effects 5. How to store 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. Driving and using machines Dermovate-NN is unlikely to affect your ability to operate machinery or to drive.
For a child iDo not use it on children under 2 years of age. iThe smaller the child the less you will need to use. iA child of 4 years needs about a third of the adult amount. iA 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. 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-NN to your face You should only apply the ointment to your face if your doctor tells you to and for not more than 5 days. Do not cover the treated area with a dressing, 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. How long You should stop using the ointment as soon as the skin problem is better. Sometimes only a few days treatment is needed. If there is no improvement after 7 days, see your doctor again. If the doctor recommends that you continue to use the ointment, you should never use it for more than 4 weeks without seeing your doctor again. If your doctor has prescribed the ointment for psoriasis you should let your doctor review your progress at regular intervals, as such treatment needs careful supervision. If you use more 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. 1. Tell your doctor, pharmacist or nearest hospital casualty department immediately. 2. Take the ointment tube with you so that people can see what you have used or taken. 3. Do this even if you feel well. If you forget to use 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. Do not use a double dose to make up for a missed dose. If you stop using If you use Dermovate-NN 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.
Side effects if you use Dermovate-NN 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: istretch marks may develop iveins under the surface of your skin may become more noticeable iincreased hair growth and changes in skin colour ithinning of your skin that may also damage more easily iweight gain, rounding of the face and high blood pressure. These are more likely to happen in infants and children. If you absorb or swallow Dermovate-NN in large quantities, it can affect your hearing, nerves and kidneys. This is unlikely when you use the ointment normally. If any of the side effects get troublesome, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
1. What this medicine is and what it is used for
Dermovate-NN ointment contains clobetasol propionate, neomycin sulphate and nystatin. iClobetasol propionate belongs to a group of medicines called steroids. It helps to reduce swelling and irritation of the skin. iNeomycin sulphate and nystatin are anti-infective medicines. They fight bacterial and fungal infections of the skin. Dermovate-NN is used to help reduce the redness and itchiness of certain skin problems. These skin problems include eczema or psoriasis, where an infection may be a problem.
5. How to store
iKeep out of the reach and sight of children. iDo not use after the expiry date which is stated on the tube and on the carton. The expiry date refers to the last day of that month. iDo not store above 25C. iDo not throw it away with your household waste or in water. Return all the unwanted medicine to your pharmacist. This will help to protect the environment.
3. How to use
Always use Dermovate-NN exactly as your doctor has told you and always read the label. Your doctor will decide on the appropriate dose to suit your condition. Ask your doctor or pharmacist if you are not sure. Using this medicine iYou usually apply Dermovate-NN 1 or 2 times a day. This may be reduced as your skin begins to get better. iIf your skin problem does not improve after 7 days talk to your doctor. iThis ointment is for use on your skin only. iDo not use on large areas of the body for a long time (such as every day for many weeks or months) - unless your doctor tells you to. iThe germs that cause infections like warm and moist conditions under dressings so always clean the skin before a fresh dressing is put on. iIf you are applying the ointment on someone else make sure you wash your hands after use or wear disposable plastic gloves. iDo not mix with any other creams or ointments. 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-NN to use with your fingertip. This picture shows one fingertip unit.
6. Further information
What Dermovate-NN Ointment contains iThe active ingredients are: clobetasol propionate (0.5 mg in 1 g of ointment) neomycin sulphate (5 mg in 1 g of ointment), nystatin (100,000 units in 1 g of ointment). iThe other ingredients are: titanium dioxide, liquid paraffin and soft white paraffin. What Dermovate-NN Ointment looks like and contents of the pack Dermovate-NN Ointment is a smooth yellow-brown ointment. It is available in aluminium tubes of 25 g or 30 g. Not all pack sizes may be marketed. Marketing Authorisation Holder Chemidex Pharma Ltd, Chemidex House, Egham Business Village, Crabtree Road, Egham, Surrey TW20 8RB. Manufacturers Purna Pharmaceuticals NV, Rijksweg 17, 2870 Puurs, Belgium. This leaflet was last revised in February 2010 'Dermovate' is a registered trademark of the GlaxoSmithKline group of companies and is used under licence. 'Chemidex' is a registered trademark.
2. Before you use
Do not use Dermovate-NN: iif you are allergic (hypersensitive) to clobetasol propionate, neomycin sulphate, nystatin or to any of the other ingredients (see Section 6) ion a child under 2 years old ito 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 - outer ear infections when the ear drum is perforated. If any of the above apply to you, or if you are not sure, speak to your doctor or pharmacist. Take special care with Dermovate-NN Check with your doctor or pharmacist before using your medicine if you: iare applying the ointment under an airtight dressing, including a child's 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 ihave psoriasis. Your doctor will want to see you more often ihave kidney problems. Your doctor may decide to change the amount or number of times you apply the ointment. If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using this medicine. Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, and herbal preparations. If Dermovate-NN is absorbed into the body in large amounts, the effects of medicines used to relax muscles during surgery can last longer or even be increased. If you are having surgery you should tell the doctor that you have used Dermovate-NN.
4. Possible side effects
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: itwo fingertips of ointment will cover both hands or one foot ithree fingertips of ointment will cover one arm isix fingertips of ointment will cover one leg ifourteen 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. Like all medicines, Dermovate-NN can cause side effects, although not everybody gets them. Do not be alarmed by this list of possible side effects. You may not experience any of them. STOP using Dermovate-NN and tell your doctor as soon as possible if: iyou find that your skin problem gets worse or becomes swollen during treatment. You may be allergic to the ointment or have a skin infection which needs other treatment. Other side effects you may notice when using Dermovate-NN include: ia feeling of burning, irritation or itching where the ointment is applied. These may be similar to the skin condition being treated iif 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.
101/L/m/3 202624
Continued over page
clobetasol propionate, neomycin sulphate, nystatin
202624 101/L/m/3
Read all of this leaflet carefully before you start using this medicine.
iKeep this leaflet. You may need to read it again. iIf you have any further questions, ask your doctor or pharmacist. iThis 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. iIf any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What this medicine is and what it is used for 2. Before you use 3. How to use 4. Possible side effects 5. How to store 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. Driving and using machines Dermovate-NN is unlikely to affect your ability to operate machinery or to drive.
For a child iDo not use it on children under 2 years of age. iThe smaller the child the less you will need to use. iA child of 4 years needs about a third of the adult amount. iA 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. 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-NN to your face You should only apply the ointment to your face if your doctor tells you to and for not more than 5 days. Do not cover the treated area with a dressing, 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. How long You should stop using the ointment as soon as the skin problem is better. Sometimes only a few days treatment is needed. If there is no improvement after 7 days, see your doctor again. If the doctor recommends that you continue to use the ointment, you should never use it for more than 4 weeks without seeing your doctor again. If your doctor has prescribed the ointment for psoriasis you should let your doctor review your progress at regular intervals, as such treatment needs careful supervision. If you use more 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. 1. Tell your doctor, pharmacist or nearest hospital casualty department immediately. 2. Take the ointment tube with you so that people can see what you have used or taken. 3. Do this even if you feel well. If you forget to use 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. Do not use a double dose to make up for a missed dose. If you stop using If you use Dermovate-NN 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.
Side effects if you use Dermovate-NN 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: istretch marks may develop iveins under the surface of your skin may become more noticeable iincreased hair growth and changes in skin colour ithinning of your skin that may also damage more easily iweight gain, rounding of the face and high blood pressure. These are more likely to happen in infants and children. If you absorb or swallow Dermovate-NN in large quantities, it can affect your hearing, nerves and kidneys. This is unlikely when you use the ointment normally. If any of the side effects get troublesome, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
1. What this medicine is and what it is used for
Dermovate-NN ointment contains clobetasol propionate, neomycin sulphate and nystatin. iClobetasol propionate belongs to a group of medicines called steroids. It helps to reduce swelling and irritation of the skin. iNeomycin sulphate and nystatin are anti-infective medicines. They fight bacterial and fungal infections of the skin. Dermovate-NN is used to help reduce the redness and itchiness of certain skin problems. These skin problems include eczema or psoriasis, where an infection may be a problem.
5. How to store
iKeep out of the reach and sight of children. iDo not use after the expiry date which is stated on the tube and on the carton. The expiry date refers to the last day of that month. iDo not store above 25C. iDo not throw it away with your household waste or in water. Return all the unwanted medicine to your pharmacist. This will help to protect the environment.
3. How to use
Always use Dermovate-NN exactly as your doctor has told you and always read the label. Your doctor will decide on the appropriate dose to suit your condition. Ask your doctor or pharmacist if you are not sure. Using this medicine iYou usually apply Dermovate-NN 1 or 2 times a day. This may be reduced as your skin begins to get better. iIf your skin problem does not improve after 7 days talk to your doctor. iThis ointment is for use on your skin only. iDo not use on large areas of the body for a long time (such as every day for many weeks or months) - unless your doctor tells you to. iThe germs that cause infections like warm and moist conditions under dressings so always clean the skin before a fresh dressing is put on. iIf you are applying the ointment on someone else make sure you wash your hands after use or wear disposable plastic gloves. iDo not mix with any other creams or ointments. 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-NN to use with your fingertip. This picture shows one fingertip unit.
6. Further information
What Dermovate-NN Ointment contains iThe active ingredients are: clobetasol propionate (0.5 mg in 1 g of ointment) neomycin sulphate (5 mg in 1 g of ointment), nystatin (100,000 units in 1 g of ointment). iThe other ingredients are: titanium dioxide, liquid paraffin and soft white paraffin. What Dermovate-NN Ointment looks like and contents of the pack Dermovate-NN Ointment is a smooth yellow-brown ointment. It is available in aluminium tubes of 25 g or 30 g. Not all pack sizes may be marketed. Marketing Authorisation Holder Chemidex Pharma Ltd, Chemidex House, Egham Business Village, Crabtree Road, Egham, Surrey TW20 8RB. Manufacturers Purna Pharmaceuticals NV, Rijksweg 17, 2870 Puurs, Belgium. This leaflet was last revised in February 2010 'Dermovate' is a registered trademark of the GlaxoSmithKline group of companies and is used under licence. 'Chemidex' is a registered trademark.
2. Before you use
Do not use Dermovate-NN: iif you are allergic (hypersensitive) to clobetasol propionate, neomycin sulphate, nystatin or to any of the other ingredients (see Section 6) ion a child under 2 years old ito 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 - outer ear infections when the ear drum is perforated. If any of the above apply to you, or if you are not sure, speak to your doctor or pharmacist. Take special care with Dermovate-NN Check with your doctor or pharmacist before using your medicine if you: iare applying the ointment under an airtight dressing, including a child's 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 ihave psoriasis. Your doctor will want to see you more often ihave kidney problems. Your doctor may decide to change the amount or number of times you apply the ointment. If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using this medicine. Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, and herbal preparations. If Dermovate-NN is absorbed into the body in large amounts, the effects of medicines used to relax muscles during surgery can last longer or even be increased. If you are having surgery you should tell the doctor that you have used Dermovate-NN.
4. Possible side effects
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: itwo fingertips of ointment will cover both hands or one foot ithree fingertips of ointment will cover one arm isix fingertips of ointment will cover one leg ifourteen 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. Like all medicines, Dermovate-NN can cause side effects, although not everybody gets them. Do not be alarmed by this list of possible side effects. You may not experience any of them. STOP using Dermovate-NN and tell your doctor as soon as possible if: iyou find that your skin problem gets worse or becomes swollen during treatment. You may be allergic to the ointment or have a skin infection which needs other treatment. Other side effects you may notice when using Dermovate-NN include: ia feeling of burning, irritation or itching where the ointment is applied. These may be similar to the skin condition being treated iif 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.
101/L/m/3 202624
Continued over page
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.
