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

Patient leaflet - DERMOVATE CREAM, CLOBETASOL PROPIONATE 0.05% W/W CREAM

Dermovate® Cream

(clobetasol propionate)

Your medicine is known by one of the above names, but will be referred to as Dermovate throughout this:

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.
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.

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.
make sure that the skin is cleansed before a fresh dressing is applied to prevent infections.
you are applying the cream on broken or damaged skin or within 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 for 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 cream 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 cream is applied.

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.

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 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 cream 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 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.

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 Cream contains 475 mg propylene glycol per gram of product, 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.

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 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 cream 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 cream on someone else make sure you wash your hands after use or wear disposable plastic gloves.
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:

I'h 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%	1%	2	2	3
3–5 years	1%	2	3	3	3%
6–10 years	2	2%	4%	3%	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 over the age of 1 year 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 cream.

Dressings or bandages should not be used on children where the cream is applied.

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. Dressings or bandages should not be used on the face where the cream is applied. 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. 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.

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.
a feeling of burning, pain, irritation or itching where the cream is applied.
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
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
blurred vision

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. 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.

5) how to store dermovate

Keep all medicines out of the sight and reach of children.

Do not store above 25°C.
Do not use the cream after the expiry date written on the tube end or carton (Exp). The expiry date refers to the last day of that month.
If your medicine becomes discoloured or show any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. These measures will help to protect the environment.

6) contents of the pack and other information

What Dermovate contains

Dermovate cream contains 0.05%w/w of clobetasol propionate as the active ingredient.

Dermovate cream also contains the following inactive ingredients: cholocresol (a preservative) in a base containing cetostearyl alcohol, glyceryl monostearate, arlacel 165, beeswax substitute 6621, propylene glycol, sodium citrate, citric acid and purified water.

What Dermovate looks like and contents of the pack

Dermovate cream comes in a 30g tube.

PL No: 46420/0134 POM

Who makes and repackages your medicine?

This product is manufactured by Industrial Farmaceutica, Cantabria, S.A., Barrio SoKa, n° 30, La Concha, Villaescusa, 39690 Santander, Cantabria, Spain. Procured from within the EU and repackaged by the Product Licence holder: Suerte Pharma Ltd, 4/5 Northolt Trading Estate, Belvue Road, Northolt, Middlesex, UB5 5QS.

More information

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

National Eczema Society, Hill House, Highgate Hill, London N19 5NA The Psoriasis Association, 2 Queensbridge, Northampton, NN4 7BF

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

Leaflet date: 10.02.2021

Dermovate is a registered trademark of GlaxoSmithKline group of companies.

Blind or partially sighted?

Is this leaflet hard to see or read?

Call 020 8839 3000 to obtain the

leaflet in a format suitable for you.

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)