Eumovate Cream

• 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 Eumovate is and what it is used for
2 What you need to know before you use Eumovate
3 How to use Eumovate
4 Possible side effects
5 How to store Eumovate
6 Contents of the pack and other information

• if you are allergic to clobetasone butyrate or any of the other ingredients of this medicine (listed in section 6)
• to treat any of the following skin problems, it could make them worse:
  • infected skin (unless the infection is being treated with an anti-infective medicine at the same time)
  • acne
  • severe flushing of skin on and around your nose (rosacea)
  • 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 Eumovate.

Talk to your doctor or pharmacist before using Eumovate if:

• you have previously had an allergic reaction with another steroid
• using around a chronic leg ulcer as you may be at increased risk of local allergic reaction or infection
• you have been advised by your doctor to use this medicine under an occlusive dressing (including a child’s nappy). Make sure that the skin is cleansed before a fresh dressing is applied to prevent infections. Occlusive dressings (including a child’s nappy) make it easier for the active ingredient to pass through the skin, making it possible to accidentally use too much.
• you are applying to thin skin such as the face, as skin is thinner and may absorb larger amounts. Dressings or bandages should not be used on the face where the cream is applied.
• you are applying to the face over a long period of time as it may cause skin thinning.
• you are applying the cream on broken skin 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 accidentally swallow a large amount of Eumovate, rinse the mouth out with plenty of water and contact a doctor or pharmacist for advice immediately.
• if an infection develops (see section 4, Possible side effects)

Contact your doctor if you experience blurred vision or other visual disturbances.

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.

• Treatment in children under 12 years of age should not normally exceed 7 days.
• Prolonged daily treatment in children can affect their growth. Continuous daily treatment for longer than 4 weeks is not recommended.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using this medicine.

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.

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.

Eumovate cream contains chlorocresol which may cause allergic reactions and cetostearyl alcohol which may cause local skin reactions (e.g. contact dermatitis).

Whilst using Eumovate 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.

• You usually apply Eumovate up to 2 times a day. This may be reduced as your skin begins to get 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) - unless your doctor tells you to.
• If you are using an emollient (moisturising) preparation allow time for Eumovate to be absorbed after each application before applying the emollient.
• 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 after 4 weeks talk to your doctor.

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 Eumovate 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. The picture in the printed leaflet shows one finger tip 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

The picture in the printed leaflet shows a diagram of the number of fingertip units needed for an adult:

Face and neck – 2 ½

Back - 7

Front – 7

One arm (not including the hand) – 3

Both sides of one hand – 1

One leg (not including the foot) – 6

One foot – 2

Do not worry if you find you need a little more or less than this. It is only a rough guide.

For a child

The table in the printed leaflet shows the number of fingertips units needed based on the child’s age:

Child’s age - 3-6 months

Face and neck – 1

Arm and hand – 1

Leg and foot - 1 ½

Front – 1

Back including buttocks - 1 ½

Child’s age – 1-2 years

Face and neck – 1 ½

Arm and hand – 1 ½

Leg and foot - 2

Front – 2

Back including buttocks – 3

Child’s age – 3-5 years

Face and neck – 1 ½

Arm and hand – 2

Leg and foot - 3

Front – 3

Back including buttocks - 3 ½

Child’s age – 6-10 years

Face and neck – 2

Arm and hand – 2 ½

Leg and foot – 4 ½

Front – 3 ½

Back including buttocks – 5

• Do not use on children younger than 12 years unless advised by a doctor.
• If the condition worsens or does not improve within 7 days, consult a doctor.
• Once the condition improves, reduce both the amount applied and the frequency of application to the minimum necessary to relieve symptoms.
• Do not use every day for more than 4 weeks at a time.

You should only apply the cream to your face if your doctor tells you to. The cream should not be used for too long as the skin on your face thins easily. Do not let the cream get into your eyes.

If you apply a lot or if a lot is accidentally swallowed, it could make you ill. Talk to your doctor or go to hospital as soon as possible.

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 use Eumovate regularly make sure you talk to your doctor before you stop using it as your condition may get worse if stopped suddenly.

• you find that your skin condition 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.

Very rare: may affect up to 1 in 10,000 people

• an increased risk of skin infection.
• an allergic skin reaction where the cream is applied.
• a feeling of burning, irritation, itching or pain where the cream is applied.
• rash, itchy bumpy skin or redness of the skin.
• increased hair growth and changes in skin colour
• thinning of your skin and it 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 eye (glaucoma)
• increased blood sugar levels or sugar in the urine
• high blood pressure
• a decrease in the level of the hormone cortisol in your blood

Not Known: frequency cannot be estimated from the available data

• blurred vision
• Steroid withdrawal reaction: If used over prolonged periods a withdrawal reaction, which might appear to be different from the previous condition, may occur in some patients during treatment or within days to weeks after stopping treatment, with some or all of the following features: redness of the skin which can extend beyond the initial area treated, a burning or stinging sensation, intense itching, peeling of the skin, oozing open sores.

Corticosteroid creams, ointments and other topical preparations come in four different potencies or strengths. These are known as mild, moderately potent, potent or very potent. Healthcare professionals will usually refer to topical corticosteroid potency rather than strength. A potent or strong corticosteroid has a much stronger effect than a mild corticosteroid when using the same amount. The percentage of active ingredient that is sometimes included on product packaging does not indicate potency. Eumovate Cream is classed as a moderate corticosteroid. Your healthcare professional will prescribe or advise a steroid of the appropriate potency for your condition.

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 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.

• The active ingredient is clobetasone butyrate. Each 1 g contains 0.5 mg of clobetasone butyrate (0.05% w/w).
• The other ingredients are glycerol, glycerol monostearate, cetostearyl alcohol (see section 2), beeswax substitute 6621 (contains paraffin), Arlacel 165, dimeticone 20, chlorocresol (see section 2), sodium citrate, citric acid monohydrate and purified water.

Within each carton is a tube with a plastic screw cap, which contains either 30 g or 100 g of cream.

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