Clobetasol Propionate 0.05% Scalp Application
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(R)
Dermovate 0.05% Scalp Application
(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.
The name of your medicine is Dermovate
0. 05. Scalp Application but will be referred to
as Dermovate throughout this leaflet.
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
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 scalp problems.
These include eczema and psoriasis that have not responded to milder steroid creams, ointments, lotions or scalp applications.
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)
• if you have a skin infection on your scalp
• on a child under 1 year.
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 liquid under an airtight dressing. These dressings make it easier for the active ingredient to pass through the skin. It is possible to accidentally end up using too much.
• 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.
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 put Dermovate on your scalp in the morning and at night. This may be reduced as your scalp problem begins to get better, or stopped when it is better.
• For use on your skin of your scalp only.
• Do not use it more often than prescribed or use it 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 treatment.
• The germs that cause infections like warm and moist conditions under dressings so always clean the skin before a fresh dressing is put on.
• Be very careful not to get the liquid in your eyes. Do not touch your eyes until you have washed your hands.
• If you wash or shampoo your hair it should be dried before applying the liquid.
• If you are applying the scalp application on someone else make sure you wash your hands after use or wear disposable plastic gloves.
• This product is flammable. Keep the liquid away from open fire and flames and all sources of ignition, including smoking, during application and immediately after you’ve used it.
• Do not dry your hair with a hairdryer.
Guidance on how to apply the liquid
2. Unscrew the bottle cap and place the nozzle directly on the scalp that needs treating.
3. Gently squeeze the bottle to cover the area with a thin and even layer of liquid.
4. You can rub this liquid in, but you don't have to.
5. Your scalp will feel cool until the liquid has dried.
6. Wash your hands again.
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 scalp application, 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.
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 scalp problem gets worse or becomes swollen during treatment. You may be allergic to the scalp application, 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 scalp application 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:
• Thinning of your skin that may also damage more easily.
• Weight gain, rounding of the face and high blood pressure. These are more likely to happen in infants and children.
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 Dermovate
Keep out of the sight and reach of children. Do not use Dermovate after the expiry date on the bottle label or carton (Exp). The expiry date refers to the last day of the month.
Do not store above 25°C.
Keep away from naked flames, fires or artificial heat as the liquid is flammable. 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.
6. Further information
What Dermovate contains
Each ml of the topical solution contains
0.05%w/w clobetasol propionate.
Also includes carbomer 980 NF, isopropyl alcohol, sodium hydroxide and purified water. What Dermovate looks like and contents of the pack
The scalp application is contained in apolyethylene squeeze bottle with a polyethylene nozzle and a tamper evident cap. Each bottle contains 100ml of clear colourless solution.
Manufactured by: Aspen Bad Oldesloe GmbH, Industriestrasse 32-36, 23843 Bad Oldesloe, Germany.
Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK Dermovate® 0.05% Scalp Application PL No: 18799/2075 rpOMl
Leaflet date: 17.09.2014 1-1
Dermovate is a registered trademark of GlaxoSmithKline group of companies
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
Package Leaflet: Information for the User
Clobetasol propionate 0.05%
Scalp Application
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.
The name of your medicine is Clobetasol propionate 0.05% Scalp Application but will be referred to as Clobetasol throughout this leaflet.
In this leaflet:
1. What Clobetasol is and what it is used for
2. Before you use Clobetasol
3. How to use Clobetasol
4. Possible side effects
5. How to store Clobetasol
6. Further information
1. What Clobetasol is and what it is used for
Clobetasol contains a medicine called clobetasol propionate. It belongs to a group of medicines called steroids. It helps to reduce swelling and irritation.
Clobetasol is used to help reduce the redness and itchiness of certain scalp problems.
These include eczema and psoriasis that have not responded to milder steroid creams, ointments, lotions or scalp applications.
2. Before you use Clobetasol
Do not use Clobetasol:
• if you are allergic (hypersensitive) to clobetasol propionate or any of the other ingredients of Clobetasol (listed in Section 6)
• if you have a skin infection on your scalp
• on a child under 1 year.
Do not use if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before using Clobetasol.
Take special care with Clobetasol
Check with your doctor or pharmacist before using your medicine if:
• you are applying the liquid under an airtight dressing. These dressings make it easier for the active ingredient to pass through the skin. It is possible to accidentally end up using too much.
• 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.
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 Clobetasol
Always use Clobetasol 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 put Clobetasol on your scalp in the morning and at night. This may be reduced as your scalp problem begins to get better, or stopped when it is better.
• For use on your skin of your scalp only.
• Do not use it more often than prescribed or use it 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 treatment.
• The germs that cause infections like warm and moist conditions under dressings so always clean the skin before a fresh dressing is put on.
• Be very careful not to get the liquid in your eyes. Do not touch your eyes until you have washed your hands.
• If you wash or shampoo your hair it should be dried before applying the liquid.
• If you are applying the scalp application on someone else make sure you wash your hands after use or wear disposable plastic gloves.
• This product is flammable. Keep the liquid away from open fire and flames and all sources of ignition, including smoking, during application and immediately after you’ve used it.
• Do not dry your hair with a hairdryer.
Guidance on how to apply the liquid
2. Unscrew the bottle cap and place the nozzle directly on the scalp that needs treating.
3. Gently squeeze the bottle to cover the area with a thin and even layer of liquid.
4. You can rub this liquid in, but you don't have to.
5. Your scalp will feel cool until the liquid has dried.
6. Wash your hands again.
If you use more Clobetasol 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 Clobetasol If you forget to apply your scalp application, 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 Clobetasol
If you use Clobetasol 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.
4. Possible side effects
Like all medicines, Clobetasol can cause side effects, although not everybody gets them. Stop using Clobetasol and tell your doctor as soon as possible if:
• you find that your scalp problem gets worse or becomes swollen during treatment. You may be allergic to the scalp application, have an infection or need other treatment.
Other side effects you may notice when using Clobetasol include:
• A feeling of burning, irritation or itching where the scalp application 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 Clobetasol for a long time, or you use a lot each time you apply it, or you apply it under an airtight dressing:
• Thinning of your skin that may also damage more easily.
• Weight gain, rounding of the face and high blood pressure. These are more likely to happen in infants and children.
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 Clobetasol
Keep out of the sight and reach of children.
Do not use Clobetasol after the expiry date on the bottle label or carton (Exp). The expiry date refers to the last day of the month.
Do not store above 25°C.
Keep away from naked flames, fires or artificial heat as the liquid is flammable. 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.
6. Further information
What Clobetasol contains
Each ml of the topical solution contains 0.05%w/w clobetasol propionate.
Also includes carbomer 980 NF, isopropyl alcohol, sodium hydroxide and purified water. What Clobetasol looks like and contents of the pack
The scalp application is contained in apolyethylene squeeze bottle with a polyethylene nozzle and a tamper evident cap. Each bottle contains 100ml of clear colourless solution.
Manufactured by: Aspen Bad Oldesloe GmbH, Industriestrasse 32-36, 23843 Bad Oldesloe, Germany.
Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK Clobetasol proprionate 0.05% Scalp Application
PL No: 18799/2075 | PO M |
Leaflet date: 17.09.2014 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