Document: leaflet MAH BRAND_PL 10949-0035 change

• leaflet MAH BRAND_PL 10949-0035
• leaflet MAH BRAND_PLPI 06464-1512
• leaflet MAH BRAND_PLPI 15184-1020
• leaflet MAH BRAND_PLPI 33902-0562

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Package leaflet: Information for the user

Eumovate® Cream

clobetasone butyrate

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 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

1. What Eumovate is and what it is used for

Eumovate contains a medicine called clobetasone butyrate. It belongs to a group of medicines called steroids. It helps to reduce swelling and irritation. Eumovate is used to:

• help reduce the redness and itchiness of certain skin problems. It is used for mild skin problems

Children

•    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.

Other medicines and Eumovate 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.

Eumovate Cream contains chloroscresol and cetostearyl alcohol

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

3. How to use Eumovate

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.    -

or to keep your skin problem under control. These skin problems include eczema, dermatitis, nappy rash or insect bites.

• help reduce inflammation of the outer ear.

2. What you need to know before you use Eumovate

Do not use Eumovate:

•    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.

Warning and precautions

Talk to your doctor or pharmacist before using

Eumovate if:

•    you have previously had an allergic reaction with another steroid

•    using for 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 have psoriasis, your doctor will want to see you more often.

•    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)

Using this medicine

•    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.

Guidance on how to apply the cream

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. 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

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

5. How to store Eumovate

•    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.

If you apply Eumovate to your face

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 use more Eumovate than you should 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.

•    Keep this medicine out of the sight and reach of children.

•    Do not use this medicine after the expiry date which is stated on the tube or carton after (EXP). The expiry date refers to the last day of that month.

•    Do not store above 25°C.

•    Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Eumovate contains

•    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, beeswax substitute 6621, Arlacel 165, dimeticone 20, chlorocresol, sodium citrate, citric acid monohydrate and purified water.

What Eumovate looks like and contents of

the pack

Within each carton is a tube with a plastic screw

cap, which contains either 30 g or 100 g of cream.

Marketing Authorisation Holder and

Manufacturer

Marketing Authorisation Holder

Glaxo Wellcome UK Ltd, Stockley Park West,

Uxbridge, Middlesex UB11 1BT

If you forget to use Eumovate

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 stop using Eumovate 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.

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 Eumovate and tell your doctor

immediately if:

•    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.

•    you have psoriasis and get raised bumps with pus under the skin. This can happen during or after treatment and is known as pustular psoriasis.

Other side effects you may notice when using

Eumovate include:

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 or itching 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

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.

Manufacturer

Glaxo Operations UK Ltd, Harmire Road,

Barnard Castle, Durham DL12 8DT More Information

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

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

Other formats

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK Only)

Please be ready to give the following information: Product name    Eumovate Cream

Reference number    10949/0035

This is a service provided by the Royal National Institute of Blind People.

This leaflet was last revised in August 2016. Eumovate is a registered trade mark of the GSK group of companies.

© 2016 GSK group of companies. All rights reserved.

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