DERMOVATE SCALP APPLICATION
Active substance: CLOBETASOL PROPIONATE
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Assessed against UK PIL dated October 2002
By austino at 10:57 pm, 7/31/06
Final Draft
DERMOVATE SCALP APPLICATION (clobetasol propionate) PATIENT INFORMATION LEAFLET
This leaflet tells you about your Dermovate Scalp Application. Please read it carefully as it contains important information and keep it in a safe place as you may like to read it again. If there is anything that you do not understand or if you need to know anything else, you should ask your doctor or pharmacist. What you should know about Dermovate Scalp Application Clobetasol propionate is one of a group of medicines called topical steroids. Topical means they are put on the skin. Topical steroids reduce the redness and itchiness of certain skin problems. (They should not be confused with anabolic steroids misused by some body builders and athletes and taken as tablets or injections). What is in Dermovate Scalp Application? Dermovate Scalp Application is a clear, colourless, slightly viscous liquid, with a strong odour of isopropanol. It contains 0.05% clobetasol propionate as the active ingredient in a base containing the following inactive ingredients: carbomer 980, isopropyl alcohol, sodium hydroxide and purified water. Dermovate Scalp Application is available in 100ml bottles. Product licence holder and manufacturer Dermovate Scalp Application is manufactured by GLAXO WELLCOME FARMACUTICA, LDA., Rua Dr. Antonio Loureiro Borges, n3, Aquiparque, Miraflores, 1495-131 Alges, Portugal and is procured from within the EU by the Product licence holder: Caseview (PL) Limited, Freeman House, Cold Bath Road, Harrogate, North Yorkshire HG2 0NA. PL 13826/1165
POM
What Dermovate Scalp Application does Dermovate Scalp Application is a strong and rapidly effective treatment for some scalp conditions such as psoriasis and eczema, which may not respond to weaker treatments. Dermovate Scalp Application also contains an alcohol which has an antiseptic effect. Before you use Dermovate Scalp Application This application has been prescribed to treat the scalp problem that you showed to your doctor. DO NOT put in on any other skin problems, especially infections of the scalp, as it could make them worse. Tell your doctor BEFORE you start using the application: - if you have ever had an allergic reaction to any cream, ointment or scalp application.
- if you are pregnant or think you may be pregnant or if you are breast-feeding Even so, your doctor may want you to use it. Eyes DO NOT let the scalp application run into your eyes. If any scalp application does enter your eye(s) bathe the affected eye(s) with plenty of water. If any irritation persists, please seek advice from your doctor. Children DO NOT use on a child under one year of age. How to use Dermovate Scalp Application If your doctor has told you in details HOW MUCH to use and HOW OFTEN then keep to this advice. If you are not sure then follow the advice in this leaflet. Unless told by your doctor: - YOU SHOULD NOT use more than this. - YOU SHOULD NOT use it for a long time (such as nearly every day for many weeks or months). Using this type of medicine continuously for a long time may affect the normal production of steroids in the body, particularly in infants and children. If your scalp problem does not improve in two to four weeks, tell your doctor. If your doctor has prescribed the scalp application for psoriasis you should let your doctor review your progress at regular intervals, as such treatment needs careful supervision. This scalp application is for use only on the skin. If any is accidentally swallowed, it could make you ill so do not delay; ask your doctor what to do or contact your nearest hospital emergency department. When washing or shampooing your hair, apply to the scalp after drying your hair. Dermovate Scalp Application is inflammable so keep it away from fire and do not dry your hair near fire or a naked flame. It is important to follow the instructions on this leaflet. If, on a few occasions by mistake you apply more than the recommended amount do not worry. If you forget to apply your scalp application, apply the correct dose when you remember or if it is close to your next application then wait until this time. Guidance on how to use Dermovate Scalp Application If your doctor has told you in details how to use the application then keep to that advice otherwise:Morning and evening:-
1. Unscrew the cap on the bottle and place the nozzle on the part of the scalp that needs treating. 2. Gently squeeze the bottle until the area to be treated is completely covered with a thin layer of liquid. You can gently rub it into the scalp if you wish.
3. Your scalp will feel cool until the liquid has dried off. The active ingredient is then left on your scalp. 4. As soon as the scalp problem looks better, use once a day or less. For a child: It should not be used in children under one year of age. Never use more than is needed to cover the scalp condition. Do not use for a long time (nearly every day for weeks or months). Do not cover with an airtight dressing. Has Dermovate Scalp Application any side effects? Most people find using this application causes no problems when used in the right amount for the correct length of time (See above). IF you find your condition gets worse during treatment you may be allergic to it or have a scalp infection or IF you think the application is causing any side effects THEN STOP USING THE SCALP APPLICATION AND TELL YOUR DOCTOR AS SOON AS POSSIBLE. Using more than the correct amount may allow the active ingredient to pass through the scalp and affect other parts of the body, especially infants and children. The use of airtight bandages or dressings over the treated areas increases this risk. Repeated courses of topical steroids over a long time may sometimes cause damage in hair growth and skin colour. Rarely, when used on psoriasis (or on stopping treatment) Dermovate Scalp Application may make the condition worse e.g. a pustular form of the disease may occur. That is why, if used in this condition, your doctor will want to see you regularly. If you feel unwell or have any unusual discomfort you do not understand, tell your doctor as soon as possible. Where to keep Dermovate Scalp Application Do not store above 25C. KEEP OUT OF THE REACH AND SIGHT OF CHILDREN. As with all medicines, keep this scalp application safely away from children. Keep it away from fire as it is flammable. Do not use or dry the hair near a fire or naked flame. What to do with any unused Dermovate Scalp Application If your doctor stops your treatment, return what is left to a pharmacist. Only keep it if your doctor tells you to. Do not use the scalp application after the expiry on the carton and bottle. If this medicine becomes discoloured or shows any sign of deterioration, consult a pharmacist who will tell you what to do. Remember Dermovate Scalp Application was prescribed for YOU so never give it to someone else to try even if they seem to have the same problem. There may be reasons why it could harm that person.
Further information This leaflet does not contain all the information about your treatment. If you have any questions or are not sure about anything, ask your doctor or pharmacist who has the information you need and will advise you. Sources of information are: National Eczema Society, 163 Eversholt Street, London NW1 1BU. Psoriasis Association, 7 Milton Street, Northampton NN2 7JG. You may also be able to find out more from books and public libraries.
Dermovate Scalp Application 21/02/2006 DERMOVATE is a registered trademark of the GlaxoSmithKline group of companies.
By austino at 10:57 pm, 7/31/06
Final Draft
DERMOVATE SCALP APPLICATION (clobetasol propionate) PATIENT INFORMATION LEAFLET
This leaflet tells you about your Dermovate Scalp Application. Please read it carefully as it contains important information and keep it in a safe place as you may like to read it again. If there is anything that you do not understand or if you need to know anything else, you should ask your doctor or pharmacist. What you should know about Dermovate Scalp Application Clobetasol propionate is one of a group of medicines called topical steroids. Topical means they are put on the skin. Topical steroids reduce the redness and itchiness of certain skin problems. (They should not be confused with anabolic steroids misused by some body builders and athletes and taken as tablets or injections). What is in Dermovate Scalp Application? Dermovate Scalp Application is a clear, colourless, slightly viscous liquid, with a strong odour of isopropanol. It contains 0.05% clobetasol propionate as the active ingredient in a base containing the following inactive ingredients: carbomer 980, isopropyl alcohol, sodium hydroxide and purified water. Dermovate Scalp Application is available in 100ml bottles. Product licence holder and manufacturer Dermovate Scalp Application is manufactured by GLAXO WELLCOME FARMACUTICA, LDA., Rua Dr. Antonio Loureiro Borges, n3, Aquiparque, Miraflores, 1495-131 Alges, Portugal and is procured from within the EU by the Product licence holder: Caseview (PL) Limited, Freeman House, Cold Bath Road, Harrogate, North Yorkshire HG2 0NA. PL 13826/1165
POM
What Dermovate Scalp Application does Dermovate Scalp Application is a strong and rapidly effective treatment for some scalp conditions such as psoriasis and eczema, which may not respond to weaker treatments. Dermovate Scalp Application also contains an alcohol which has an antiseptic effect. Before you use Dermovate Scalp Application This application has been prescribed to treat the scalp problem that you showed to your doctor. DO NOT put in on any other skin problems, especially infections of the scalp, as it could make them worse. Tell your doctor BEFORE you start using the application: - if you have ever had an allergic reaction to any cream, ointment or scalp application.
- if you are pregnant or think you may be pregnant or if you are breast-feeding Even so, your doctor may want you to use it. Eyes DO NOT let the scalp application run into your eyes. If any scalp application does enter your eye(s) bathe the affected eye(s) with plenty of water. If any irritation persists, please seek advice from your doctor. Children DO NOT use on a child under one year of age. How to use Dermovate Scalp Application If your doctor has told you in details HOW MUCH to use and HOW OFTEN then keep to this advice. If you are not sure then follow the advice in this leaflet. Unless told by your doctor: - YOU SHOULD NOT use more than this. - YOU SHOULD NOT use it for a long time (such as nearly every day for many weeks or months). Using this type of medicine continuously for a long time may affect the normal production of steroids in the body, particularly in infants and children. If your scalp problem does not improve in two to four weeks, tell your doctor. If your doctor has prescribed the scalp application for psoriasis you should let your doctor review your progress at regular intervals, as such treatment needs careful supervision. This scalp application is for use only on the skin. If any is accidentally swallowed, it could make you ill so do not delay; ask your doctor what to do or contact your nearest hospital emergency department. When washing or shampooing your hair, apply to the scalp after drying your hair. Dermovate Scalp Application is inflammable so keep it away from fire and do not dry your hair near fire or a naked flame. It is important to follow the instructions on this leaflet. If, on a few occasions by mistake you apply more than the recommended amount do not worry. If you forget to apply your scalp application, apply the correct dose when you remember or if it is close to your next application then wait until this time. Guidance on how to use Dermovate Scalp Application If your doctor has told you in details how to use the application then keep to that advice otherwise:Morning and evening:-
1. Unscrew the cap on the bottle and place the nozzle on the part of the scalp that needs treating. 2. Gently squeeze the bottle until the area to be treated is completely covered with a thin layer of liquid. You can gently rub it into the scalp if you wish.
3. Your scalp will feel cool until the liquid has dried off. The active ingredient is then left on your scalp. 4. As soon as the scalp problem looks better, use once a day or less. For a child: It should not be used in children under one year of age. Never use more than is needed to cover the scalp condition. Do not use for a long time (nearly every day for weeks or months). Do not cover with an airtight dressing. Has Dermovate Scalp Application any side effects? Most people find using this application causes no problems when used in the right amount for the correct length of time (See above). IF you find your condition gets worse during treatment you may be allergic to it or have a scalp infection or IF you think the application is causing any side effects THEN STOP USING THE SCALP APPLICATION AND TELL YOUR DOCTOR AS SOON AS POSSIBLE. Using more than the correct amount may allow the active ingredient to pass through the scalp and affect other parts of the body, especially infants and children. The use of airtight bandages or dressings over the treated areas increases this risk. Repeated courses of topical steroids over a long time may sometimes cause damage in hair growth and skin colour. Rarely, when used on psoriasis (or on stopping treatment) Dermovate Scalp Application may make the condition worse e.g. a pustular form of the disease may occur. That is why, if used in this condition, your doctor will want to see you regularly. If you feel unwell or have any unusual discomfort you do not understand, tell your doctor as soon as possible. Where to keep Dermovate Scalp Application Do not store above 25C. KEEP OUT OF THE REACH AND SIGHT OF CHILDREN. As with all medicines, keep this scalp application safely away from children. Keep it away from fire as it is flammable. Do not use or dry the hair near a fire or naked flame. What to do with any unused Dermovate Scalp Application If your doctor stops your treatment, return what is left to a pharmacist. Only keep it if your doctor tells you to. Do not use the scalp application after the expiry on the carton and bottle. If this medicine becomes discoloured or shows any sign of deterioration, consult a pharmacist who will tell you what to do. Remember Dermovate Scalp Application was prescribed for YOU so never give it to someone else to try even if they seem to have the same problem. There may be reasons why it could harm that person.
Further information This leaflet does not contain all the information about your treatment. If you have any questions or are not sure about anything, ask your doctor or pharmacist who has the information you need and will advise you. Sources of information are: National Eczema Society, 163 Eversholt Street, London NW1 1BU. Psoriasis Association, 7 Milton Street, Northampton NN2 7JG. You may also be able to find out more from books and public libraries.
Dermovate Scalp Application 21/02/2006 DERMOVATE is a registered trademark of the GlaxoSmithKline group of companies.
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.
