DERMOVATE SCALP APPLICATION, CLOBETASOL PROPIONATE 0.05% W/W SCALP APPLICATION - patient leaflet, side effects, dosage

S877 LEAFLET Dermovate 20210505

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 frequently relapsing dermatoses 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 (hypersensitive) 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 of age.

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 experience newly developed bone pain or worsening of previous bone symptoms during a treatment with Dermovate especially if you have been using Dermovate for a prolonged time or repeatedly.
• you use other oral/topical medication containing corticosteroids or medication intended to control your immune system (e.g. for autoimmune disease or after a transplantation). Combining Dermovate with these medicines may result in serious infections.
• 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. Do not bandage or otherwise cover the treated scalp area, unless directed to do so by your doctor.
• If directed to cover the treated area with a dressing, make sure that the skin is cleansed before a fresh dressing is applied to prevent infections.
• you have psoriasis, your doctor will want to see you more often.
• you are applying the liquid to broken, damaged or thin skin.
• you are applying to a large surface area.

Contact your doctor if you experience blurred vision or other visual disturbances.

If an infection develops during the use of this medicine talk to your doctor or pharmacist.

Be very careful not to get the liquid in your eyes. If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using this medicine.

Children

• Do not use this medicine on a child under the age of 1 year.
• Avoid continuous treatment for a long period of time in children over the age of 1 year, as their skin is thinner than adults and as a result may absorb larger amounts.
• Use on children should be limited to a few days and reviewed weekly.
• Dressings or bandages should not be used on children where the scalp application is applied.

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.

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.

3. how to use dermovate

Always use this medicine exactly as your doctor has told you. 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. If directed to cover the treated area with a dressing, always clean the skin before a fresh dressing is put on to help prevent infection of the skin beneath the dressing.
• 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. Your scalp will feel cool until the liquid has dried.

• 5 Wash your hands again.

• 6 Do not exceed the prescribed amount.

Use in children

• Do not use this medicine on children under 1 year of age.
• It is especially important in children not to exceed the prescribed amount.
• 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. Do not apply extra Dermovate to make up for a missed dose.

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 medicine, ask your doctor or pharmacist.

Not Known (frequency cannot be estimated from the available data)

• blurred vision

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

4. POSSIBLE SIDE EFFECTS

5. HOW TO STORE DERMOVATE

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop using Dermovate and tell your doctor immediately 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)

• skin thinning, this may cause stretch marks
• blood vessels under the surface of your skin may become more noticeable.

Very Rare (may affect up to 1 in 10,000 people)

Use of Dermovate for a long period of time, or use under an airtight dressing, may cause the following symptoms:

• increased weight
• moon face, rounding of the face
• obesity
• skin thinning
• skin wrinkling
• skin dryness
• changes to the colour of your skin
• increased body hair
• hair loss/lack of hair growth/damaged looking hair

Other very rare skin reactions that may occur are:

• allergic reaction at the site of application
• worsening of condition
• application site irritation/pain
• redness
• rash or hives
• if you have psoriasis you may get raised bumps with pus under the skin. This can happen very rarely during or after treatment and is known as pustular psoriasis
• skin infection
• acne

In children, also look out for the following symptoms:

• delayed weight gain
• slow growth

Very rare side effects that may show up in blood tests or when your doctor gives you a medical examination:

• a decrease in the level of the hormone cortisol in your blood
• increased levels of sugar in your blood or urine
• high blood pressure
• cloudy lens in the eye (cataract)
• increased pressure in the eye (glaucoma)
• vision problems caused by detachment of the retina in the eye (central serous chorioretinopathy)
• weakening of the bones through gradual loss of mineral (osteoporosis);
• additional tests may be needed after your medical examination to confirm if you have this condition
• KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
• Do not store above 25°C.
• Use within 3 months after first opening.
• Keep container tightly closed when not in use. Contents are flammable. Keep away from fire, flame and heat. Do not leave in direct sunlight.
• Do not use after the expiry date printed on the carton label or blister strip.
• If your doctor tells you to stop using the medicine, please take it back to the pharmacist for safe disposal. Only keep the medicine if your doctor tells you to.
• If the medicine becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.

6. contents of the pack and other information

What Dermovate contains

• It contains active ingredient clobetasol propionate. Each 1g of liquid contains 0.5mg of clobetasol propionate (0.05% w/w).
• Dermovate scalp application also contains the following inactive ingredients: isopropyl alcohol, carbomer, sodium hydroxide and purified water.

What Dermovate looks like and contents of the pack

Dermovate scalp application is clear, colourless liquid with a strong odour of isopropanol.

Dermovate scalp application is available as bottles of 100 ml.

Product Licence holder

Procured from within the EU and repackaged by the Product Licence holder: S&M Medical Ltd, Chemilines House, Alperton Lane, Wembley, HA0 1DX.

Manufacturer

This product is manufactured by

• Glaxo Wellcome Farmaceutica Lda, 3 Arquiparque, Miraflores, 1495–31 Alges, Portugal
• Aspen Bad Oldesloe GmbH, Industriestrasse 32–36, 23843 Bad Oldesloe, Germany.

| POM | PL: 19488/0877

Leaflet revision date: 05 May 2021

Blind or partially sighted? Is this leaflet hard to see or read? Call 02087997607 to obtain the leaflet in large print, tape, CD or Braille.

Dermovate is a registered trade mark of Glaxo Group Limited, UK.

S877 LEAFLET Dermovate 20210505 More Information

If you have any questions or are not sure about anything, ask your doctor or pharmacist who will advise you.

You may be able to find out more information from books in public libraries.

S877 LEAFLET Clobetasol 20210505

PACKAGE LEAFLET: INFORMATION FOR THE USER

CLOBETASOL PROPIONATE 0.05% w/w

SCALP APPLICATION

Your medicine is known as Clobetasol propionate 0.05% w/w scalp application and will be referred to as Clobetasol propionate throughout the following patient information leaflet.

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 propionate is and what it is used for

• 2 What you need to know before you use Clobetasol propionate

• 3 How to use Clobetasol propionate

• 4 Possible side effects

• 5 How to store Clobetasol propionate

• 6 Contents of the pack and other information

1. what clobetasol propionate is and what it is used for

Clobetasol propionate Scalp Application (called ‘Clobetasol propionate’ 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 propionate is used to help reduce the redness and itchiness of certain scalp problems. These include frequently relapsing dermatoses 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 propionate

Do not use Clobetasol propionate:

• if you are allergic (hypersensitive) 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 of age.

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 propionate.

Warnings and precautions

Talk to your doctor or pharmacist before using your medicine if:

• you experience newly developed bone pain or worsening of previous bone symptoms during a treatment with Clobetasol propionate especially if you have been using Clobetasol propionate for a prolonged time or repeatedly.
• you use other oral/topical medication containing corticosteroids or medication intended to control your immune system (e.g. for autoimmune disease or after a transplantation). Combining Clobetasol propionate with these medicines may result in serious infections.
• 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. Do not bandage or otherwise cover the treated scalp area, unless directed to do so by your doctor.
• If directed to cover the treated area with a dressing, make sure that the skin is cleansed before a fresh dressing is applied to prevent infections.
• you have psoriasis, your doctor will want to see you more often.
• you are applying the liquid to broken, damaged or thin skin.
• you are applying to a large surface area.

Contact your doctor if you experience blurred vision or other visual disturbances.

If an infection develops during the use of this medicine talk to your doctor or pharmacist.

Be very careful not to get the liquid in your eyes. If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using this medicine.

Children

• Do not use this medicine on a child under the age of 1 year.
• Avoid continuous treatment for a long period of time in children over the age of 1 year, as their skin is thinner than adults and as a result may absorb larger amounts.
• Use on children should be limited to a few days and reviewed weekly.
• Dressings or bandages should not be used on children where the scalp application is applied.

Other medicines and Clobetasol propionate

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.

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.

3. how to use clobetasol propionate

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Using this medicine

• You usually put Clobetasol propionate 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. If directed to cover the treated area with a dressing, always clean the skin before a fresh dressing is put on to help prevent infection of the skin beneath the dressing.
• 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. Your scalp will feel cool until the liquid has dried.

• 5 Wash your hands again.

• 6 Do not exceed the prescribed amount.

Use in children

• Do not use this medicine on children under 1 year of age.
• It is especially important in children not to exceed the prescribed amount.
• 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 propionate scalp application.

If you use more Clobetasol propionate 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 propionate

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. Do not apply extra Clobetasol propionate to make up for a missed dose.

If you stop using Clobetasol propionate

If you use Clobetasol propionate 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 medicine, ask your doctor or pharmacist.

• weakening of the bones through gradual loss of mineral (osteoporosis);
• additional tests may be needed after your medical examination to confirm if you have this condition

Not Known (frequency cannot be estimated from the available data)

• blurred vision

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects, you can help provide more information on the safety of this medicine.

4. POSSIBLE SIDE EFFECTS

5. HOW TO STORE CLOBETASOL PROPIONATE

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop using Clobetasol propionate and tell your doctor immediately 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 propionate 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)

• skin thinning, this may cause stretch marks
• blood vessels under the surface of your skin may become more noticeable.

Very Rare (may affect up to 1 in 10,000 people)

Use of Clobetasol propionate for a long period of time, or use under an airtight dressing, may cause the following symptoms:

• increased weight
• moon face, rounding of the face
• obesity
• skin thinning
• skin wrinkling
• skin dryness
• changes to the colour of your skin
• increased body hair
• hair loss/lack of hair growth/damaged looking hair

Other very rare skin reactions that may occur are:

• allergic reaction at the site of application
• worsening of condition
• application site irritation/pain
• redness
• rash or hives
• if you have psoriasis you may get raised bumps with pus under the skin. This can happen very rarely during or after treatment and is known as pustular psoriasis
• skin infection
• acne

In children, also look out for the following symptoms:

• delayed weight gain
• slow growth

Very rare side effects that may show up in blood tests or when your doctor gives you a medical examination:

• a decrease in the level of the hormone cortisol in your blood
• increased levels of sugar in your blood or urine
• high blood pressure
• cloudy lens in the eye (cataract)
• increased pressure in the eye (glaucoma)
• vision problems caused by detachment of the retina in the eye (central serous chorioretinopathy)
• KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
• Do not store above 25°C.
• Use within 3 months after first opening.
• Keep container tightly closed when not in use. Contents are flammable. Keep away from fire, flame and heat. Do not leave in direct sunlight.
• Do not use after the expiry date printed on the carton label or blister strip.
• If your doctor tells you to stop using the medicine, please take it back to the pharmacist for safe disposal. Only keep the medicine if your doctor tells you to.
• If the medicine becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Clobetasol propionate contains

• It contains active ingredient clobetasol propionate. Each 1g of liquid contains 0.5mg of clobetasol propionate (0.05% w/w).
• Clobetasol propionate scalp application also contains the following inactive ingredients: isopropyl alcohol, carbomer, sodium hydroxide and purified water.

What Clobetasol propionate looks like and contents of the pack

Clobetasol propionate scalp application is clear, colourless liquid with a strong odour of isopropanol.

Clobetasol propionate scalp application is available as bottles of 100 ml.

Product Licence holder

Procured from within the EU and repackaged by the Product Licence holder: S&M Medical Ltd, Chemilines House, Alperton Lane, Wembley, HA0 1DX.

Manufacturer

This product is manufactured by

• Glaxo Wellcome Farmaceutica Lda, 3 Arquiparque, Miraflores, 1495–31 Alges, Portugal
• Aspen Bad Oldesloe GmbH, Industriestrasse 32–36, 23843 Bad Oldesloe, Germany.