Dermovate

• For psoriasis and eczema
• Also used for other skin infections
• Ointment, cream or liquid solution
• Also suitable for children aged 1 and above

Dermovate contains the active ingredient clobetasol propionate, which is a potent topical corticosteroid. Dermovate is used to treat various conditions, including:

• Eczema.
• Psoriasis.
• Discoid lupus erythematosus.

Dermovate is used to reduce the symptoms of these skin conditions, such as redness, itchiness and scaling. Dermovate only treats the symptoms, not the cause of the skin problems. This medicine is only prescribed when other, less potent medicines are found to be ineffective.

Dermovate is available as ointment, cream and liquid solution. Always use Dermovate as directed by your doctor. The general guidelines for use are as follows.

Cream and ointment:

• Apply thinly to the affected areas and massage into the skin gently and evenly. It's best to have a shower or bath before applying this medicine.
• Unless you are meant to apply Dermovate to your hands as a part of the treatment, wash them again after using the cream or ointment.
• If you are also using an emollient (moisturiser), allow time for Dermovate to be absorbed into your skin before applying the emollient.

If you have relapsing eczema, you may switch to a maintenance dose once your symptoms improve. This will reduce the chance of eczema flare-ups. In this case, apply a thin layer of Dermovate twice a week.

Liquid:

Dermovate liquid solution is for external use on the scalp only.

• Only use on dry hair.
• The solution contains flammable alcohol. Do not use it near naked flames or lit objects, such as gas and electric fires and lit cigarettes, or near other sources of heat such as hairdryers.
• Avoid contact with the eyes.
• Unscrew the bottle cap and place the nozzle directly on the scalp. Gently squeeze the bottle to cover the area with a thin and even layer of liquid. You can rub this liquid in, but you don’t have to. Your scalp will feel cool until the liquid has dried.

Dosage

The usual dosage for adults and children aged 1 and above is:

• Use once or twice a day. As soon as the condition starts to improve the medicine can be used less frequently. You can also ask your doctor to prescribe a milder treatment.

If your condition does not improve within two to four weeks of treatment, speak to your doctor. Your doctor should check your skin after four weeks.

Do not use more than 30- 60 grams of this medicine a week, unless the doctor advises otherwise.

Alcohol/driving

This medicine does not interact with alcohol and will normally not affect your ability to drive or operate machinery.

If you use more than you should/miss a dose/stop using Dermovate

If by mistake on a few occasions you use more than you should, do not worry. If you continue to use too much over a period of time or you accidentally swallow Dermovate, contact your doctor or pharmacist for advice.

If you forget to apply Dermovate, 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 missed doses.

Always consult your doctor before stopping the treatment.

Dermovate is not suitable for everyone. Do not use Dermovate if you are allergic to any of the ingredients in this medicine (see section ‘What Dermovate contains').

Do not use Dermovate to treat any of the following skin problems, as it could make them worse:

• Infected skin due to a virus, bacteria, fungus or parasite (unless the infection is being treated).
• Severe flushing of skin, with of without spots (rosacea).
• Spotty red rash around your mouth (perioral dermatitis).
• Itchy skin which is not inflamed.
• Itching around your anus or genitals.
• A skin condition resulting in scaly skin (ichthyosis vulgaris), a disease in children that causes skin rash (juvenile dermatomyositis) or fragile blood vessels in the skin.
• Skin conditions caused by the use of corticosteroids, such as stripe-like skin marks (striae).
• Adolescent spots (acne).

Dermovate is not suitable for children under the age of 1.

When should this medicine be used with caution?

In some cases, special care should be taken with this medicine. For instance, if there is an increased chance of side effects. The chance of side effects increases if:

• You are applying this medicine to a large surface area.
• You have been using Dermovate for a prolonged time.
• You are applying the medicine under an airtight dressing (e.g., bandages or diapers), or within skin folds (between thighs or in armpits).
• You are applying Dermovate to thin skin such as the face, skin folds or genitals.
• You are applying Dermovate on broken or damaged skin.
• You have a decreased kidney or liver function.
• You are a child or elderly person.

See the package leaflet for a full list of situations in which Dermovate should be used with caution. If any of these warnings apply to you, or if you are unsure, talk to your doctor.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Other medicines and Dermovate

Other medicines may influence the effects of Dermovate, or Dermovate may affect other medicines. These medicines include:

• Ritonavir (antiviral medicine).
• Itraconazole (used to treat fungal infections).

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

The side effects reported in association with the use of Dermovate include:

Uncommon (may affect up to 1 in 100 people):

• Skin thinning, this may cause stretch marks (straie).
• The appearance of blood vessels under the surface of your skin.

Other skin reactions that may occur are:

• Itchy skin.
• Application site irritation/pain.
• Allergic reaction at the site of application.
• Worsening of condition.

Use of Dermovate for a long period of time, or use under an airtight dressing, may cause the following symptoms:

• Increased weight/obesity.
• Moon face/rounding of the face (Cushing syndrome).
• Skin thinning/ageing.
• Dry skin.
• Changes to the colour of your skin.
• Increased body hair, lack of hair growth, hair loss.
• Skin rash or redness, nettle rash or hives.
• Psoriasis with raised bumps with pus under the skin (pustular psoriasis).
• Infection in people with a weakened immune system.
• Milia (small white bumps (cysts) under the surface of the skin) in eldery people.
• Blood effusions.
• Rosacea with or without skin thinning.

In children, also look out for the following symptoms:

• Delayed weight gain.
• Slow growth.

See the package leaflet for a complete list of side effects.

Consult a doctor if you experience any side effects. This includes any possible side effects not listed in this leaflet.

The active substance is clobetasol-17-propionate.

The other ingredients in the cream are: chlorocresol (preservative), glyceryl monostearate (E471), arlacel 165 (emulgator), cetostearyl alcohol, white beeswax substitute 6621, propylene glycol (E1520), sodium citrate (E331), citric acid monohydrate (E330), purified water.

The other ingredients in the ointment are: propylene glycol (E1520), sorbitan sesquioleate, vaseline.

The other ingredients in the liquid solution are: carbomer, isopropyl alcohol, sodium hydroxide (E524), purified water.

The manufacturer of Dermovate is:

Cream and ointment:

Glaxo Operations UK limited (trading as Glaxo Wellcome Operations)
Harmire Road, Barnard Castle
Co. Durham DL12 8DT
England

Liquid:

Aspen Bad Oldesloe GmbH Industriestrasse 32-36
D-23843, Bad Oldesloe
Germany

Read the package leaflet before use.