Clobetasol Propionate 0.05% Cream
S183 LEAFLET Dermovate 20150227
PACKAGE LEAFLET: INFORMATION FOR THE USER DERMOVATE® CREAM (clobetasol 17-propionate)
Your medicine is known as Dermovate Cream but will be referred to as Dermovate throughout the following 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 of the 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 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.
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)
• 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.
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 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
Face and neck:
2% 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 worry if you find you need a little more or less than this. It is only a rough guide.
For a child aged 1 - 10
|
Number of fingerti |
p units needed | ||||
|
Child’s age |
Face |
Arm |
Leg |
Front |
Back |
|
and |
and |
and |
including | ||
|
neck |
hand |
foot |
buttocks | ||
|
1 -2 years |
1 / |
1 / |
2 |
2 |
3 |
|
3-5 years |
1 / |
2 |
3 |
3 |
3 / |
|
6-10 years |
2 |
2 / |
4 / |
3 / |
5 |
• 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.
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 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.
5. HOW TO STORE DERMOVATE
• KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
• Dermovate should not be stored above 25°C.
• Do not use Dermovate after the expiry date on the carton or tube label.
• 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
• Dermovate contains the active ingredient, clobetasol 17-propionate 0.05%w/w.
• Dermovate also contains the following inactive ingredients: cetostearyl alcohol, glyceryl monostearate, Arlacel 165, beeswax substitute 6621, propylene glycol, chlorocresol, sodium citrate dihydrate, citric acid monohydrate and purified water.
What Dermovate looks like and contents of the pack
Dermovate is a white cream and is available in 30g tubes.
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 Operations UK Ltd., Barnard Castle, United Kingdom.
• Glaxo Wellcome Operations UK Ltd., Barnard Castle, United Kingdom.
• Industrial Farmaceutica Cantabria, S.A., Ctra. Cazona-Adarzo, s/n, 39011 Santander, Spain.
| POM | PL No: 19488/0183 Leaflet revision date: 27 February 2015
Dermovate is a registered trademark of Glaxo Group Ltd., UK.
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.
S183 LEAFLET Dermovate 20150227
S183 LEAFLET Clobetasol 20150227
PACKAGE LEAFLET: INFORMATION FOR THE USER CLOBETASOL PROPIONATE 0.05% CREAM (clobetasol 17-propionate)
Your medicine is known as Clobetasol Propionate 0.05% Cream but will be referred to as Clobetasol Cream throughout the following 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 of the 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 Cream is and what it is used for
2 What you need to know before you use Clobetasol Cream
3 How to use Clobetasol Cream
4 Possible side effects
5 How to store Clobetasol Cream
6 Contents of the pack and other information
1. WHAT CLOBETASOL CREAM IS AND WHAT IT IS USED FOR
Clobetasol Cream contains a medicine called clobetasol propionate. It belongs to a group of medicines called steroids. It helps to reduce swelling and irritation.
Clobetasol Cream 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.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE CLOBETASOL CREAM
Do not use Clobetasol Cream:
• 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 Cream. Warning and precautions
Talk to your doctor or pharmacist before using Clobetasol Cream 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 Cream
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 Cream 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.
3. HOW TO USE CLOBETASOL CREAM
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 Cream 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 Clobetasol Cream 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
Face and neck:
2’/j 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 worry if you find you need a little more or less than this. It is only a rough guide.
For a child aged 1 - 10_
|
Number of fingerti |
p units needed | ||||
|
Child’s age |
Face |
Arm |
Leg |
Front |
Back |
|
and |
and |
and |
including | ||
|
neck |
hand |
foot |
buttocks | ||
|
1 -2 years |
1 / |
1 / |
2 |
2 |
3 |
|
3-5 years |
1 / |
2 |
3 |
3 |
3 / |
|
6-10 years |
2 |
2 / |
4 / |
3 / |
5 |
• 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 Cream 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 Cream 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 Cream 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 Cream
If you use Clobetasol Cream 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.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although
not everybody gets them.
Stop using Clobetasol Cream 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
Cream 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.
5. HOW TO STORE CLOBETASOL CREAM
• KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
• Clobetasol Cream should not be stored above 25°C.
• Do not use Clobetasol Cream after the expiry date on the carton or tube label.
• 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 Cream contains
• Clobetasol Cream contains the active ingredient, clobetasol 17-propionate 0.05%w/w.
• Clobetasol Cream also contains the following inactive ingredients: cetostearyl alcohol, glyceryl monostearate, Arlacel 165, beeswax substitute 6621, propylene glycol, chlorocresol, sodium citrate dihydrate, citric acid monohydrate and purified water.
What Clobetasol Cream looks like and contents of the pack
Clobetasol Cream is a white cream and is available in 30g tubes.
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 Operations UK Ltd., Barnard Castle, United Kingdom.
• Glaxo Wellcome Operations UK Ltd., Barnard Castle, United Kingdom.
• Industrial Farmaceutica Cantabria, S.A., Ctra. Cazona-Adarzo, s/n, 39011 Santander, Spain.
| POM | PL No: 19488/0183 Leaflet revision date: 27 February 2015 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.
S183 LEAFLET Clobetasol 20150227