Dermovate Ointment
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 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:
• frequently relapsing eczema
• psoriasis (thickened patches of inflamed, red skin, often covered by silvery
scales), excluding widespread plaque psoriasis
• lichen planus (a skin disease that causes itchy, reddish-purple, flat-topped
bumps on the wrists, forearms or lower legs)
• discoid lupus erythematosus (a disease of the skin most often affecting the
face, ears and scalp causing scarring and increased sensitivity of the affected
skin to sunlight)
• 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 of age
• 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 anus or genitals (penis or vagina)
- infected skin (unless the infection is being treated with an anti-infective
medicine at the same time)
- itchy skin which is not inflamed
- widespread plaque psoriasis, except single lesions.
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 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 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.
• make sure that the skin is cleansed before a fresh dressing is applied to prevent
infections.
• you are applying the ointment on broken or damaged skin or within the skin folds.
• you are applying to a large surface area.
• you have psoriasis, your doctor will want to see you more often.
• you are using around a chronic leg ulcer as you may be at increased risk of local
allergic reaction or infection.
• 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, as Dermovate may cause skin
thinning. Use on the face should be limited to 5 days. Dressings or bandages
should not be used on the face where the ointment is applied.
If an infection develops during the use of this medicine, talk to your doctor or
pharmacist.
Contact your doctor if you experience blurred vision or other visual disturbances.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist
before using this medicine.
If there is a worsening of your condition during use consult your prescriber – you
may be experiencing an allergic reaction, have an infection or your condition
requires a different treatment.
If you experience a recurrence of your condition shortly after stopping treatment,
within 2 weeks, do not restart using the cream/ointment without consulting your
prescriber unless your prescriber has previously advised you to so. If your condition
has resolved and on recurrence the redness extends beyond the initial treatment
area and you experience a burning sensation, please seek medical advice before
restarting treatment.
Children
• Do not use this medicine in children under 1 year of age.
• Avoid continuous treatment for a long period of time in infants and children over 1
year of age, 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.
• Dressings or bandages should not be used on children where the ointment is
applied.
If this product comes into contact with dressings, clothing and bedding the fabric can
be easily ignited with a naked flame. You should keep away from fire when using this
product.
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.
If you do use Dermovate when breast-feeding, do not use it on your breast area to
ensure that the baby does not accidentally get Dermovate in their mouth.
Dermovate Ointment contains 50 mg propylene glycol per gram of product.
Propylene glycol may cause skin irritation.
Whilst using Dermovate do not smoke or go near naked flames due to the risk of
severe burns. Fabric (clothing, bedding, dressing etc) that has been in contact with
this product burns more easily and is a serious fire hazard. Washing clothing and
bedding may reduce product build-up but not totally remove it
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 once or twice a day. This may be
reduced as your skin begins to get better, or stopped when it is better. Your
doctor may prescribe a weaker steroid for you to use instead.
• If you are also using an emollient (moisturiser), allow time for Dermovate to be
absorbed into your skin before applying the emollient.
• This ointment is for use on your skin only.
• Do not use for more than 4 weeks without talking to your doctor. If you need
treatment for a long time, your doctor may decide you need to use a milder
cream or ointment.
• If your skin problem worsens or does not improve within 2 to 4 weeks, talk to your
doctor.
• The germs that cause infections like the 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.
• If you are applying the ointment on someone else make sure you wash your
hands after use or wear disposable plastic gloves.
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.
[Pictogram of 1 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.
For adolescents (≥ 12 years old) and adults
[Pictogram of an adult with fingertip units to be used as per text below with
arrows pointing to relevant body part]
Face and neck:
2 ½ 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 fingertip units needed
Child’s
age
Face
and
neck
Arm
and
hand
Leg
and
foot
Front
Back
including
buttocks
1-2 years
1 ½ 1 ½ 2 2 3
3-5 years
1 ½ 2 3 3 3 ½
6-10 years
2 2 ½ 4 ½ 3 ½ 5
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 5 days
unless your doctor has told you to use it for longer. Your doctor may want to see
the child every week, whilst using the ointment.
• Dressings or bandages should not be used on children where the ointment is
applied.
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. Dressings or bandages
should not be used on the face where the ointment is applied.
