Clobetasol Propionate 0.05% W/W Scalp Application
Package Leaflet: Information for the user
Dermovate® Scalp Application
(clobetasol propionate)
Read all of this leaflet carefully before you start
using this medicine because it contains
important information for you.
• 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 only.
Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Dermovate is and what it is used for
2. What you need to know before you use Dermovate
3. How to use Dermovate
4. Possible side effects
5. How to store Dermovate
6. Contents of the pack and other information
1. What Dermovate is and what it is used for
Dermovate Scalp Application (called ‘Dermovate' in this leaflet) 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. What you need to know before you use Dermovate
Do not use Dermovate:
• if you are allergic to clobetasol propionate or any of the other ingredients of this medicine (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.
Warnings and precautions
Talk to your doctor or pharmacist before using your
medicine if:
• you have previously had an allergic reaction with another steroid.
• 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.
• you are applying the liquid to broken skin or within the skin folds.
• you are applying to a large surface area.
• you are applying to thin skin or on children as their skin is thinner than adults and as a result may absorb large amounts. Use on children should be limited to a few days and reviewed weekly.
• Dressing or bandages should not be used on children where the scalp application is applied.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using the medicine.
Pregnancy, breast-feeding and fertility
If you are pregnant or are breast-feeding, think you may become pregnant or are planning to have a baby ask your doctor or pharmacist for advice before taking this medicine.
Other medicines and Dermovate
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine, especially if you are taking ritonavir and itraconazole medications.
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
1 Wash your hands.
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.
7 It is important not to exceed the prescribed amount.
Use in Children
A course of treatment for a child should not normally last more than a few days, unless your doctor has told you to use it for longer. The doctor may want to see the child every week whilst using Dermovate scalp application.
If you use more Dermovate than you should
If you apply too much or if 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 as your condition may get worse if stopped suddenly.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side-effects
Like all medicines, this medicine 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 , you develop a generalised rash or your skin becomes swollen during treatment. you may be allergic to the scalp application, have an infection or need other treatment.
• you have psoriasis and get raised bumps with pus under the skin. This can happen during or after the treatment and is known as pustular psoriasis.
Other side effects you may notice when using
Dermovate include:
Common (may affect up to 1 in 10 people)
• A feeling of burning, pain, irritation or itching where the scalp application is applied.
Uncommon (may affect up to 1 in 100 people)
• Stretch marks may develop.
• Veins under the surface of your skin may become more noticeable.
Rare (may affect up to 1 in 1,000 people)
• An increased risk of infection
• An allergic skin reaction where the scalp application is applied
• Rash, itchy bumpy skin or redness of the skin
• Thinning and dryness of the skin and it may also damage or wrinkle more easily
• An increase or reduction in hair growth or hair loss and changes in skin colour.
• Weight gain, rounding of the face
• Delayed weight gain or slowing of growth in children
• Bones can become thin, weak and break easily
• Cloudy lens in the eye (cataract) or increased pressure in the eye (glaucoma)
• Increased blood sugar levels or sugar in the urine
• High blood pressure
5. How to store Dermovate
• Keep out of the sight and reach of children.
• Do not store above 25°C.
• Flammable. Keep away from fire, flame and heat.
• Do not leave in direct sunlight.
• Keep container tightly closed when not in use.
• After first opening Dermovate should be used within 3 months.
• Do not use Dermovate after the expiry date on the bottle label or carton (Exp). The expiry date refers to the last day of that month.
• 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. Contents of the pack and other information
What Dermovate contains
• The active ingredient is clobetasol propionate. Each 10 ml contains 0.005 mg of clobetasol propionate (0.05% w/w).
• The other ingredients are carbomer, isopropyl alcohol, sodium hydroxide and purified water.
What Dermovate looks like and contents of the pack
Dermovate is colorless, clear or slightly cloudy, slightly viscous, with a strong odour of alcohol.
It comes in white, opaque bottles with applicator and polyethylene cap, containing 100 ml of cutaneous solution.
Manufactured by: Aspen Bad Oldesloe GmbH, Industriestrasse 32-36, 23843 Bad Oldesloe, Germany
Procured from within the EU & repackaged by PL holder: Kosei Pharma UK Limited, 956 Buckingham Avenue, Slough Trading Estate, Slough, SL1 4NL.
Dermovate scalp application,
PL: 39352/0092
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.
Leaflet date: 15.04.2016
Dermovate is a registered trademark of the GlaxoSmithKline group of companies
Reporting of side effects
If you get any side effects, talk to your doctor or 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.
Clobetasol Propionate 0.05%w/w Scalp Application
Read all of this leaflet carefully before you start
using this medicine because it contains
important information for you.
• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Clobetasol is and what it is used for
2. What you need to know before you use Clobetasol
3. How to use Clobetasol
4. Possible side effects
5. How to store Clobetasol
6. Contents of the pack and other information
1. What Clobetasol is and what it is used for
Clobetasol Propionate 0.05%w/w Scalp Application (called ‘Clobetasol' in this leaflet) 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. What you need to know before you use Clobetasol
Do not use Clobetasol:
• if you are allergic to clobetasol propionate or any of the other ingredients of this medicine (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.
Warnings and precautions
Talk to your doctor or pharmacist before using your
medicine if:
• you have previously had an allergic reaction with another steroid.
• 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.
• you are applying the liquid to broken skin or within the skin folds.
• you are applying to a large surface area.
• you are applying to thin skin or on children as their skin is thinner than adults and as a result may absorb large amounts. Use on children should be limited to a few days and reviewed weekly.
• Dressing or bandages should not be used on children where the scalp application is applied.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using the medicine.
Pregnancy, breast-feeding and fertility
If you are pregnant or are breast-feeding, think you may become pregnant or are planning to have a baby ask your doctor or pharmacist for advice before taking this medicine.
Other medicines and Clobetasol
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine, especially if you are taking ritonavir and itraconazole medications.
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
1. Wash your hands.
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.
7. It is important not to exceed the prescribed amount
Use in Children
A course of treatment for a child should not normally last more than a few days, unless your doctor has told you to use it for longer. The doctor may want to see the child every week whilst using Clobetasol scalp application.
If you use more Clobetasol than you should
If you apply too much or if 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 as your condition may get worse if stopped suddenly.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side-effects
Like all medicines, this medicine 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 , you develop a generalised rash or your skin becomes swollen during treatment. you may be allergic to the scalp application, have an infection or need other treatment.
• you have psoriasis and get raised bumps with pus under the skin. This can happen during or after the treatment and is known as pustular psoriasis.
Other side effects you may notice when using Clobetasol include:
Common (may affect up to 1 in 10 people)
• A feeling of burning, pain, irritation or itching where the scalp application is applied.
Uncommon (may affect up to 1 in 100 people)
• Stretch marks may develop.
• Veins under the surface of your skin may become more noticeable.
Rare (may affect up to 1 in 1,000 people)
• An increased risk of infection
• An allergic skin reaction where the scalp application is applied
• Rash, itchy bumpy skin or redness of the skin
• Thinning and dryness of the skin and it may also damage or wrinkle more easily
• An increase or reduction in hair growth or hair loss and changes in skin colour.
• Weight gain, rounding of the face
• Delayed weight gain or slowing of growth in children
• Bones can become thin, weak and break easily
• Cloudy lens in the eye (cataract) or increased pressure in the eye (glaucoma)
• Increased blood sugar levels or sugar in the urine
• High blood pressure
Reporting of side effects
If you get any side effects, talk to your doctor or 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 store above 25°C.
• Flammable. Keep away from fire, flame and heat.
• Do not leave in direct sunlight.
• Keep container tightly closed when not in use.
• After first opening Dermovate should be used within 3 months.
• Do not use Dermovate after the expiry date on the bottle label or carton (Exp). The expiry date refers to the last day of that month.
• 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. Contents of the pack and other information
What Clobetasol contains
• The active ingredient is clobetasol propionate. Each 10 ml contains 0.005 mg of clobetasol propionate (0.05% w/w).
• The other ingredients are carbomer, isopropyl alcohol, sodium hydroxide and purified water.
What Clobetasol looks like and contents of the pack
Clobetasol is colorless, clear or slightly cloudy, slightly viscous, with a strong odour of alcohol.
It comes in white, opaque bottles with applicator and polyethylene cap, containing 100 ml of cutaneous solution.
Manufactured by: Aspen Bad Oldesloe GmbH, Industriestrasse 32-36, 23843 Bad Oldesloe, Germany
Procured from within the EU & repackaged by PL holder: Kosei Pharma UK Limited 956 Buckingham Avenue, Slough Trading Estate, Slough, SL1 4NL.
Clobetasol Propionate 0.05%w/w Scalp Application, i—
PL: 39352/0092 LPO
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.
Leaflet date: 15.04.2016