Eumovate Eczema & Dermatitis 0.05% Cream

Document: leaflet MAH BRAND_PL 00079-0623 change


Eczema & Dermatitis 0.05% Cream Clobetasone Butyrate

Please read right through this leaflet before you start using this medicine.

This medicine is available without prescription, but you still need to use Eumovate Eczema & Dermatitis 0.05% Cream carefully to get the best results from it.

•    Keep this leaflet you may need to read it again.

•    If you have any questions, or if there is anything you do not understand, ask your pharmacist.

In this leafli!'

1.    What Eumo\i

2.    Check before

3.    How to use

4.    Possible side

5.    How to store

6.    Further inforji

7.    More about

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2. Check before you use Eumovate

Do not use Eumovate

•    if you have ever had an allergic reaction to clobetasone butyrate or to any of the other ingredients (listed in Section 6)

•    on broken skin

•    on skin infected with viruses

(e.g. herpes or chicken pox), fungus (e.g. thrush, ringworm or athlete's foot) or bacteria (e.g. impetigo)

•    on the face, groin, genitals or between the toes

•    under a dressing (e.g. a plaster)

•    if you are under 12 years unless your doctor tells you to.

Take special care with Eumovate

•    Avoid applying the cream to the eyes.

•    If symptoms persist after 7 days of treatment, see your doctor.

Ask your doctor before you use this medicine:

•    if you have psoriasis, acne or seborrhoeic dermatitis

•    if you have already used the cream on the same area twice before.

If you are taking other medicines

Talk to your doctor or pharmacist before using this cream if you are taking any medicines; particularly prescribed or over-the-counter topical steroids (e.g. hydrocortisone).

Pregnancy and breast-feeding

Talk to your doctor before using Eumovate if you are pregnant, trying to become pregnant or are breast-feeding.

3. How to use Eumovate

I For external use only. This product is intended for short term use only. You should I apply the cream for the shortest time necessary to relieve your symptoms.

Adults and children aged 12 years and over:

Use the cream twice a day, for up to 7 days.

•    Wash and dry your hands.

•    Squeeze out the correct amount of cream onto your index finger. The picture below gives you an idea of how much to use. Half a fingertip will cover a patch of skin the same size as the palm of your hand.

•    Gently rub cream into the skin you are treating twice a day.

•    Wash your hands again

(unless it is your hands you are treating).

How much to use

•    Squeeze out the cream along the top of your index finger: see the picture.

•    From the crease in your finger, squeeze the cream halfway to your fingertip. This will cover a patch of skin the same size as the palm of your hand.

•    Use the fingertip unit as a guide. For smaller areas, use a smaller amount. This cream is not meant to treat large areas.

•    If you use a bit too much of the cream by mistake, don't worry - but try to keep to the fingertip unit.

•    Half a fingertip will cover a patch of skin the same size as the '

palm of your hand.

HDo not use more than the recommended dose.

If you forget to use the cream Use it when you remember.

Do not use Eumovate for more than 7 days.

If your symptoms continue or worsen, see your doctor.

4. Possible side effects

Like all medicines, Eumovate can have side effects, but not everybody gets them.

Stop using the product and consult your doctor if you see any of the following side effects:

Very rare (affects less than 1 in 10,000 people)

• redness of the skin • itching • hives

• local skin burning • increased hair growth • Changes in skin colour • Skin thinning

You may also find that your symptoms get worse while using the cream. Tell your doctor if this happens.

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:

By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store Eumovate Eczema & Dermatitis 0.05% Cream

Keep out of the sight and reach of children.

Do not use this medicine after the 'EXP' date shown on the pack. Do not store above 25°C.

6.    Further information

Active ingredient The cream contains Clobetasone Butyrate 0.05% w/w

Other ingredients Glycerol, glycerol monostearate, cetostearyl alcohol, beeswax substitute 6621, arlacel 165, dimeticone 20, chlorocresol, sodium citrate, citric acid monohydrate and purified water.

The tube contains 15 g of cream.

The marketing authorisation holder is GlaxoSmithKline Consumer Healthcare, Brentford, TW8 9GS, U.K. and all enquiries should be sent to this address.

The manufacturer is Glaxo Wellcome Operations,

Harmire Road, Barnard Castle, Co. Durham, DL12 8DT, UK.

7.    More about managing eczema and dermatitis

Skin specialist advice

Skin specialists often advise people with eczema or dermatitis to use emollient (moisturising) skin products, including creams and bath oils, to keep moisture in the skin. This can make your skin more resistant to flare-ups.

Avoid using soap and heavily scented products. Ask your pharmacist for further information.

If a rash comes back

Sometimes people with dermatitis find their rash soon comes back after treatment, or never disappears completely. This is often because they are still in contact with their trigger i.e. what causes the reaction. If you can't work out what's wrong, ask your doctor for advice.

Common triggers

•    Jewellery including earrings or studs (especially gold-plated earrings)

•    Coins

•    Watch buckles, metal straps or the metal back of a watch

•    Metal studs or fastenings on jeans, bras or underwear.

All of these have a metal in them called nickel, which is a very common trigger. If you react badly to nickel, all of the triggers in the list could be a problem. So if you've reacted badly to one of the common triggers, you'll need to watch out for the other common triggers.

Other common triggers

Triggers include rubber and pine tree sap, which are used in all sorts of items we touch every day. You might find triggers:

•    In the home: such as plasters, furniture polish, varnishes, rubber gloves or elastic in clothes

•    In substances you use at work: such as glues, oils, lubricants or cement

•    In the garden: certain plants and weeds, gardening gloves.

Even if it is not practical to avoid triggers, there are often practical steps you can take - see next section. Finding out more.

Finding out more

•    You may be able to find out more from public libraries.

•    You can contact the National Eczema Society,

Hill House, Highgate Hill, London, N19 5NA. Helpline 0870 241 3604.

•    If you have other questions about Eumovate or are not sure about anything, ask your doctor or pharmacist who will be able to advise you.

December 2015. The information in this leaflet only applies to Eumovate Eczema & Dermatitis 0.05% Cream. Eumovate is a registered trade mark of the GSK group of companies.