Clobetasol Propionate 0.05% W/W Ointment
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.
Your medicine is called Dermovate Ointment but will be referred to as Dermovate throughout the leaflet.
In this leaflet:
^ What Dermovate is and what it is used for What you need to know before you use Dermovate
^ How to use Dermovate ^4 Possible side effects ^5 How to store Dermovate ^ Contents of the pack and other information
M 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 and dermatitis that have not responded to milder steroid creams or ointments.
• you have psoriasis, your doctor will want to see you more often.
• you are applying the ointment on broken skin or within the 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 ointment 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 ointment 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 planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Dermovate Ointment contains propylene glycol
Propylene glycol may cause skin irritation.
fa 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)
• 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.
Warnings 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 ointment 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 ointment.
^ 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 it is better.
• This ointment 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 ointment 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 ointment
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 ointment 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 ointment to your hands as a part of the treatment, wash them again after using the ointment.
Face 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):
(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 fingertip units needed | |||||
|
Face |
Arm |
Leg |
Back | ||
|
UlIKl S |
and |
and |
and |
Front |
including |
|
neck |
hand |
foot |
buttocks | ||
|
1-2 years |
IB |
\‘h |
2 |
2 |
3 |
|
3-5 years |
1'/: |
2 |
3 |
3 |
Vh |
|
6-10 years |
2 |
2'h |
4 'h |
Vk |
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 ointment.
If you have psoriasis
If you have thick patches of psoriasis on your elbows or knees, your doctor may suggest applying the ointment under an airtight dressing. It will only be at night to help the ointment to start working. After a short period of time you will then apply the ointment as normal.
If you apply Dermovate to your face
You should only apply the ointment to your face if your doctor tells you to. It should be limited to 5 days, as the skin on your face thins easily. Do not let the ointment 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 ointment, 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.
^ 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 ointment, 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 ointment 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 ointment 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.
• Thinning of your skin that may also damage more easily.
• 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.
How to store Dermovate
• Do not store above 30°C.
• KEEP OUT OF THE SIGHT AND REACH OF CHILDREN
• Do not use Dermovate after the expiry date which is stated on the tube, carton label or on the carton after "EXP”. The expiry date refers to the last day of that month.
• 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.
Contents of the pack and other information
What Dermovate contains
• Each gram of ointment contains 0.5 mg of clobetasol propionate (0.05% w/w).
• The other ingredients are propylene glycol, sorbitan sesquioleate and white soft paraffin.
What Dermovate looks like and contents of the pack
Dermovate is an off-white ointment.
Each pack contains 25g or 4 x 25g of ointment.
Manufacturer and Licence Holder
Dermovate is manufactured by GlaxoSmithKline Pharmaceuticals SA, ul. Grunwaldzka 189,
60-322 Poznan, Poland 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
Dermovate is a registered trademark of GlaxoSmithKline Group of Companies.
| POM PL 15184/1490
Leaflet revision date: 29/01/15
Blind or partially sighted?
Is this leaflet hard to see or read? Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.
Ref: 1490/290115/1/B
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.
Your medicine is called Clobetasol propionate Ointment but will be referred to as Clobetasol propionate throughout the leaflet.
In this leaflet:
^ What Clobetasol propionate is and what it is used for
What you need to know before you use Clobetasol propionate ^ How to use Clobetasol propionate ^ Possible side effects
How to store Clobetasol propionate ra Contents of the pack and other information
^ What Clobetasol propionate is and what it is used for
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 propionate 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 and dermatitis that have not responded to milder steroid creams or ointments.
• you have psoriasis, your doctor will want to see you more often.
• you are applying the ointment on broken skin or within the 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 ointment 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 ointment 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 planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Clobetasol propionate Ointment contains propylene glycol
Propylene glycol may cause skin irritation.
^ 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.
What you need to know before you use Clobetasol propionate
Do not use Clobetasol propionate:
• if you are allergic 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.
Warnings 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 ointment 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 ointment.
Using this medicine
• You usually apply a thin layer of Clobetasol propionate 1 or 2 times a day. This may be reduced as your skin
begins to get better, or stopped when it is better.
• This ointment 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 ointment 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 ointment
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 ointment 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 ointment to your hands as a part of the treatment, wash them again after using the ointment.
Face 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):
(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.
|
Number of fingertip unite needed | |||||
|
Child's |
Face |
Arm |
Leg |
Back | |
|
and |
and |
and |
Front |
including | |
|
neck |
hand |
foot |
buttocks | ||
|
1-2 years |
I’/t |
114 |
2 |
2 |
3 |
|
3-5 years |
1 Vz |
2 |
3 |
3 |
316 |
|
6-10 years |
2 |
214 |
4 14 |
3 14 |
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 ointment.
If you have psoriasis
If you have thick patches of psoriasis on your elbows or knees, your doctor may suggest applying the ointment under an airtight dressing. It will only be at night to help the ointment to start working.
After a short period of time you will then apply the ointment as normal.
If you apply Clobetasol propionate to your face
You should only apply the ointment to your face if your doctor tells you to. It should be limited to 5 days, as the skin on your face thins easily. Do not let the ointment 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 ointment, 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.
Possible side effects
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 ointment, 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 ointment 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 ointment 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.
• Thinning of your skin that may also damage more easily.
• 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.
^ How to store Clobetasol propionate
• Do not store above 30°C.
• KEEP OUT OF THE SIGHT AND REACH OF CHILDREN
• Do not use Clobetasol propionate after the expiry
date which
is stated on the tube, carton label or on the carton after "EXP”. The expiry date refers to the last day of that month.
• 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.
What Clobetasol propionate contains
• Each gram of ointment contains 0.5 mg of clobetasol propionate (0.05% w/w).
• The other ingredients are propylene glycol, sorbitan sesquioleate and white soft paraffin.
What Clobetasol propionate looks like and contents of the pack
Clobetasol propionate is an off-white ointment.
Each pack contains 25g or 4 x 25g of ointment.
Manufacturer and Licence Holder
Clobetasol Propionate is manufactured by GlaxoSmithKline Pharmaceuticals SA, ul. Grunwaldzka 189, 60-322 Poznan, Poland 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
I POM PL 15184/1490
Leaflet revision date: 29/01/15
Blind or partially sighted?
Is this leaflet hard to see or read? Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.
Ref: 1490/290115/2/B