Dermovate Cream
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 of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
Your medicine is called Dermovate Cream, however throughout this leaflet it will be referred to as Dermovate.
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
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 skin problems. These skin problems include eczema, psoriasis, lichen planus, discoid lupus, dermatitis and other skin conditions that have not responded to milder steroid creams or ointments.
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)
• on a child under 1 year old
• to 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
- infected skin (unless the infection is being treated with an anti-infective medicine at the same time)
- itchy skin which is not inflamed
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.
Warning and precautions
Talk to your doctor or pharmacist before using Dermovate if:
• you have previously had an allergic reaction with another steroid
• you are applying the cream 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 cream.
• you have psoriasis, your doctor will want to see you more often.
• you are applying the cream on broken skin or within skin folds.
• using for a chronic leg ulcer as you may be at increased risk of local allergic reaction or infection.
• you are applying to a large surface area or within the skin folds.
• you are applying near eyes or on eyelids, as cataracts or glaucoma may result if the cream repeatedly enters the eye.
• you are applying to thin skin such as the face or on children as their skin is thinner than adults and as a result may absorb larger amounts. Use on children should be limited to 5 days and reviewed weekly. Use on the face should be limited to 5 days.
• dressing or bandages should not be used on children or on the face where the cream is applied
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using 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.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Dermovate Cream contains propylene glycol, cetostearyl alcohol and chlorocresol
Propylene glycol may cause skin irritation. Cetostearyl alcohol may cause local skin reactions (eg. contact dermatitis). Chlorocresol may cause allergic reactions.
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 apply a thin layer of Dermovate 1 or 2 times a day. This may be reduced as your skin begins to get better, or stopped when better.
• This cream is for use on your skin only.
• Do not use on large areas of the body 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 cream or ointment
• The germs that cause infections like warm and moist conditions under dressings so always clean the skin before a fresh dressing is put on.
• If you are applying the cream on someone else make sure you wash your hands after use or wear disposable plastic gloves.
• If your skin problem does not improve in 2 to 4 weeks, talk to your doctor.
Guidance on how to apply the cream
1 Wash your hands.
2 Apply a thin layer to the affected area(s) and gently rub into the skin until it has all disappeared. You can measure how much Dermovate to use with your fingertip. For children you will need to use less cream but still use an adult finger to measure out the fingertip unit. This picture shows one fingertip unit.
3 Unless you are meant to apply the cream to your hands as a part of the treatment, wash them again after using the cream.
For an adult
For a child aged 1 - 10
• Do not use it 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 5 days - unless your doctor has told you to use it for longer. The doctor may want to see the child every week, whilst using the cream.
If you have psoriasis
If you have thick patches of psoriasis on your elbows or knees, your doctor may suggest applying the cream under an airtight dressing. It will only be at night to help the cream to start working. After a short period of time you will then apply the cream as normal.
If you apply Dermovate to your face
You should only apply the cream to your face if your doctor tells you to. It should be limited to only 5 days as the skin on your face thins easily. Do not let the cream get into your eyes. If it does, wash it out with plenty of water.
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 cream, 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 medicine, ask your doctor or pharmacist.
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 skin problem gets worse, you develop a generalised rash or your skin becomes swollen during treatment. You may be allergic to the cream, 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 cream 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 cream is applied
• Rash, itchy bumpy skin or redness of the skin
• Thinning and dryness of your 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. 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.
Expiry Date
Do not use this medicine after the expiry date shown on the carton label or tube. Only keep this medicine if your doctor tells you to. If your cream becomes discoloured or shows any other signs of deterioration, consult your pharmacist (chemist) who will tell you what to do. You should return any left over cream to your pharmacist.
How to Store
• Do not store above 30°C
• KEEP THIS MEDICINE OUT OF SIGHT AND REACH OF CHILDREN
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Important
Remember this medicine is for you. It can only be prescribed by a doctor. Never give your medicine to other people, it may harm them, even if their symptoms are the same. This leaflet does not tell you everything about your medicine. If you have any question or are not sure about anything, ask your doctor or pharmacist (chemist) He/she will have additional information about this medicine and will be able to advise you.
What Dermovate contains
Dermovate Cream contains 0.05% w/w of clobetasol propionate as the active ingredient.
Your cream also contains the following inactive ingredients: cetostearyl alcohol, glyceryl monostearate, Arlacel 165, beeswax substitute 6621, propylene glycol, chlorocresol, sodium citrate, citric acid monohydrate, purified water.
What Dermovate looks like and contents of the pack
Dermovate Cream is a white, smooth, shiny cream packaged in a metal collapsible tube with a plastic screw cap and tamper evident seal.
Dermovate Cream is available in tubes of 30g.
Who manufactured your medicine?
Dermovate Cream is manufactured by INDUSTRIAL FARMACEUTICA CANTABRIA, S.A. Ctra. Cazona-adarzo, s/n, 39011, Spain and is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
PL Number: 15184/1060
Leaflet revision date: 30/03/15
Dermovate Cream is a registered trademark of The 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. You may be able to find out more information from books in public libraries.
Blind or partially sighted?
Is this leaflet hard to see or read? Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.
Clovate ® Cream
(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 of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
See section 4.
Your medicine is called Clovate Cream, however throughout this leaflet it will be referred to as Clovate.
What is in this leaflet
1 What Clovate is and what it is used for
2 What you need to know before you use Clovate
3 How to use Clovate
4 Possible side effects
5 How to store Clovate
6 Contents of the pack and other information
1. What Clovate is and what it is used for
Clovate contains a medicine called clobetasol propionate. It belongs to a group of medicines called steroids. It helps to reduce swelling and irritation. Clovate is used to help reduce the redness and itchiness of certain skin problems. These skin problems include eczema, psoriasis, lichen planus, discoid lupus, dermatitis and other skin conditions that have not responded to milder steroid creams or ointments.
Do not use Clovate:
• if you are allergic (hypersensitive) to clobetasol propionate or any of the other ingredients of this medicine (listed in Section 6)
• on a child under 1 year old
• to 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
- infected skin (unless the infection is being treated with an anti-infective medicine at the same time)
- itchy skin which is not inflamed
Do not use if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before using Clovate.
Warning and precautions
Talk to your doctor or pharmacist before using Clovate if:
• you have previously had an allergic reaction with another steroid
• you are applying the cream 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 cream.
• you have psoriasis, your doctor will want to see you more often.
• you are applying the cream on broken skin or within skin folds.
• using for a chronic leg ulcer as you may be at increased risk of local allergic reaction or infection.
• you are applying to a large surface area or within the skin folds.
• you are applying near eyes or on eyelids, as cataracts or glaucoma may result if the cream repeatedly enters the eye.
• you are applying to thin skin such as the face or on children as their skin is thinner than adults and as a result may absorb larger amounts. Use on children should be limited to 5 days and reviewed weekly. Use on the face should be limited to 5 days.
Package Leaflet: Information for the User
• dressing or bandages should not be used on children or on the face where the cream is applied
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using this medicine.
Other medicines and Clovate
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 breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Clovate Cream contains propylene glycol, cetostearyl alcohol and chlorocresol
Propylene glycol may cause skin irritation. Cetostearyl alcohol may cause local skin reactions (eg. contact dermatitis). Chlorocresol may cause allergic reactions.
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 apply a thin layer of Clovate 1
or 2 times a day. This may be reduced as your skin begins to get better, or stopped when better.
• This cream is for use on your skin only.
• Do not use on large areas of the body 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 cream or ointment
• The germs that cause infections like warm and moist conditions under dressings so always clean the skin before a fresh dressing is put on.
• If you are applying the cream on someone else make sure you wash your hands after use or wear disposable plastic gloves.
• If your skin problem does not improve in 2 to 4 weeks, talk to your doctor.
Guidance on how to apply the cream
1 Wash your hands.
2 Apply a thin layer to the affected area(s) and gently rub into the skin until it has all disappeared. You can measure how much Clovate to use with your fingertip. For children you will need to use less cream but still use an adult finger to measure out the fingertip unit. This picture shows one fingertip unit.
3 Unless you are meant to apply the cream to your hands as a part of the treatment, wash them again after using the cream.
For an adult
Fate and neck:
2Vi fingertip units.
Back: 7 fingertip units. Front: 7 fingertip units.
One arm (not including the hand):
3 fingertip units.
Both sides of one hand:
1 fingertip unit
One leg (not including the foot):
6 fingertip units.
One foot:
2 fingertip units.
• Do not use it 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 5 days - unless your doctor has told you to use it for longer. The doctor may want to see the child every week, whilst using the cream.
If you have psoriasis
If you have thick patches of psoriasis on your elbows or knees, your doctor may suggest applying the cream under an airtight dressing. It will only be at night to help the cream to start working. After a short period of time you will then apply the cream as normal.
If you apply Clovate to your face
You should only apply the cream to your face if your doctor tells you to. It should be limited to only 5 days as the skin on your face thins easily. Do not let the cream get into your eyes. If it does, wash it out with plenty of water.
If you use more Clovate 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 Clovate
If you forget to apply your cream, 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 Clovate
If you use Clovate 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.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop using Clovate and tell your doctor immediately if:
• you find that your skin problem gets worse, you develop a generalised rash or your skin becomes swollen during treatment. You may be allergic to the cream, 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 Clovate include:
Common (may affect up to 1 in 10 people)
• A feeling of burning, pain, irritation or itching where the cream 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 cream is applied
• Rash, itchy bumpy skin or redness of the skin
• Thinning and dryness of your 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. 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
Expiry Date
Do not use this medicine after the expiry date shown on the carton label or tube. Only keep this medicine if your doctor tells you to. If your cream becomes discoloured or shows any other signs of deterioration, consult your pharmacist (chemist) who will tell you what to do. You should return any left over cream to your pharmacist.
How to Store
• Do not store above 30°C
• KEEP THIS MEDICINE OUT OF SIGHT AND REACH OF CHILDREN
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Important
Remember this medicine is for you. It can only be prescribed by a doctor. Never give your medicine to other people, it may harm them, even if their symptoms are the same. This leaflet does not tell you everything about your medicine. If you have any question or are not sure about anything, ask your doctor or pharmacist (chemist) He/she will have additional information about this medicine and will be able to advise you.
What Clovate contains
Clovate Cream contains 0.05% w/w of clobetasol propionate as the active ingredient.
Your cream also contains the following inactive ingredients: cetostearyl alcohol, glyceryl monostearate, Arlacel 165, beeswax substitute 6621, propylene glycol, chlorocresol, sodium citrate, citric acid monohydrate, purified water.
What Clovate looks like and contents of the pack Clovate Cream is a white, smooth, shiny cream packaged in a metal collapsible tube with a plastic screw cap and tamper evident seal.
Clovate Cream is available in tubes of 30g.
Who manufactured your medicine?
Clovate Cream is manufactured by INDUSTRIAL FARMACEUTICA CANTABRIA, S.A. Ctra. Cazona-adarzo, s/n, 39011, Spain and is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
PL Number: 15184/1060
Leaflet revision date: 30/03/15
Clovate Cream is a registered trademark of The 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. You may be able to find out more information from books in public libraries.
Blind or partially sighted?
Is this leaflet hard to see or read? Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.
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 of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
See section 4.
Your medicine is called Clobetasol propionate Cream, however throughout this leaflet it will be referred to as Clobetasol propionate.
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
Clobetasol propionate contains a medicine called clobetasol propionate. It belongs to a group of medicines called steroids. It helps to reduce swelling and irritation. Clobetasol propionateis used to help reduce the redness and itchiness of certain skin problems. These skin problems include eczema, psoriasis, lichen planus, discoid lupus, dermatitis and other skin conditions that have not responded to milder steroid creams or ointments.
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)
• on a child under 1 year old
• to 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
- infected skin (unless the infection is being treated with an anti-infective medicine at the same time)
- itchy skin which is not inflamed
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.
Warning and precautions
Talk to your doctor or pharmacist before using Clobetasol propionate if:
• you have previously had an allergic reaction with another steroid
• you are applying the cream 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 cream.
• you have psoriasis, your doctor will want to see you more often.
• you are applying the cream on broken skin or within skin folds.
• using for a chronic leg ulcer as you may be at increased risk of local allergic reaction or infection.
• you are applying to a large surface area or within the skin folds.
• you are applying near eyes or on eyelids, as cataracts or glaucoma may result if the cream repeatedly enters the eye.
• you are applying to thin skin such as the face or on children as their skin is thinner than adults and as a result may absorb larger amounts. Use on children should be limited to 5 days and reviewed weekly. Use on the face should be limited to 5 days.
• dressing or bandages should not be used on children or on the face where the cream is applied
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using this medicine.
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 breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Clobetasol propionate Cream contains propylene glycol, cetostearyl alcohol and chlorocresol
Propylene glycol may cause skin irritation. Cetostearyl alcohol may cause local skin reactions (eg. contact dermatitis). Chlorocresol may cause allergic reactions.
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 apply a thin layer of Clobetasol propionate1 or 2 times a day. This may be reduced as your skin begins to get better, or stopped when better.
• This cream is for use on your skin only.
• Do not use on large areas of the body 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 cream or ointment
• The germs that cause infections like warm and moist conditions under dressings so always clean the skin before a fresh dressing is put on.
• If you are applying the cream on someone else make sure you wash your hands after use or wear disposable plastic gloves.
• If your skin problem does not improve in 2 to 4 weeks, talk to your doctor.
Guidance on how to apply the cream
1 Wash your hands.
2 Apply a thin layer to the affected area(s) and gently rub into the skin until it has all disappeared. You can measure how much Clobetasol propionateto use with your fingertip. For children you will need to use less cream but still use an adult finger to measure out the fingertip unit. This picture shows one fingertip unit.
3 Unless you are meant to apply the cream to your hands as a part of the treatment, wash them again after using the cream.
For an adult
Fate and neck:
2Vr fingertip units.
Back: 7 fingertip units. Front: 7 fingertip units.
One arm (not including the hand):
3 fingertip units.
Both sides of one hand:
1 fingertip unit.
One leg (not including the foot):
6 fingertip units.
One foot
2 fingertip units.
• Do not use it 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 5 days - unless your doctor has told you to use it for longer. The doctor may want to see the child every week, whilst using the cream.
If you have psoriasis
If you have thick patches of psoriasis on your elbows or knees, your doctor may suggest applying the cream under an airtight dressing. It will only be at night to help the cream to start working. After a short period of time you will then apply the cream as normal.
If you apply Clobetasol propionate to your face
You should only apply the cream to your face if your doctor tells you to. It should be limited to only 5 days as the skin on your face thins easily. Do not let the cream get into your eyes. If it does, wash it out with plenty of water.
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 cream, 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 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.
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 skin problem gets worse, you develop a generalised rash or your skin becomes swollen during treatment. You may be allergic to the cream, 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 cream 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 cream is applied
• Rash, itchy bumpy skin or redness of the skin
• Thinning and dryness of your 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. 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 inf5rmation on the safety of this medicine.
Expiry Date
Do not use this medicine after the expiry date shown on the carton label or tube. Only keep this medicine if your doctor tells you to. If your cream becomes discoloured or shows any other signs of deterioration, consult your pharmacist (chemist) who will tell you what to do. You should return any left over cream to your pharmacist.
How to Store
• Do not store above 30°C
• KEEP THIS MEDICINE OUT OF SIGHT AND REACH OF CHILDREN
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Important
Remember this medicine is for you. It can only be prescribed by a doctor. Never give your medicine to other people, it may harm them, even if their symptoms are the same. This leaflet does not tell you everything about your medicine. If you have any question or are not sure about anything, ask your doctor or pharmacist (chemist) He/she will have additional information about this medicine and will be able to advise you.
What Clobetasol propionate contains
Clobetasol propionate Cream contains 0.05% w/w of clobetasol propionate as the active ingredient.
Your cream also contains the following inactive ingredients: cetostearyl alcohol, glyceryl monostearate, Arlacel 165, beeswax substitute 6621, propylene glycol, chlorocresol, sodium citrate, citric acid monohydrate, purified water.
What Clobetasol propionate looks like and contents of the pack
Clobetasol propionate Cream is a white, smooth, shiny cream packaged in a metal collapsible tube with a plastic screw cap and tamper evident seal. Clobetasol propionate Cream is available in tubes of 30g.
Who manufactured your medicine?
Clobetasol propionateCream is manufactured by INDUSTRIAL FARMACEUTICA CANTABRIA, S.A. Ctra. Cazona-adarzo, s/n, 39011, Spain and is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
PL Number: 15184/1060
Leaflet revision date: 30/03/15
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.
Blind or partially sighted?
Is this leaflet hard to see or read? Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.