EUMOVATE Clobetasone Butyrate 0.05% W/W Cream

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EUMOVATE Clobetasone butyrate 0.05% w/w cream

Consumer Medicine Information

What is in this leaflet • untreated bacterial infections Ask your doctor or pharmacist if such as cellulitis (infection of the

you have any questions about skin), folliculitis (infection of the Please read this leaflet carefully before you start using EUMOVATE why this medicine has been hair follicle), furunculosis (boils) Cream. recommended for you. or impetigo (blisters) Your doctor or pharmacist may • fungal infections such as This leaflet answers some common have recommended it for another athletes foot and jock itch questions about EUMOVATE. It reason. does not contain all the available • viral infections such as cold information. It does not take the sores, chicken pox or shingles place of talking to your doctor or • parasitic infestations such as pharmacist. Before using EUMOVATE scabies All medicines have risks and • psoriasis unless recommended benefits. Your doctor or pharmacist When you must not use it by your doctor has weighed the risks of you using EUMOVATE against the benefits Do not use EUMOVATE if you they expect it will have for you. If you have any of these have an allergy to: conditions, ask your doctor or pharmacist for advice. Use EUMOVATE as instructed and • any medicine containing follow the advice given in this clobetasone butyrate leaflet. Do not use on delicate skin areas • any of the ingredients listed at such as the face, groin, genitals If you have any concerns about the end of this leaflet. or between the toes. using this medicine, ask your • any other similar medicines Do not use EUMOVATE: doctor or pharmacist. such as hydrocortisone. • if you are pregnant or may be pregnant Keep this leaflet with the Some of the symptoms of an • medicine. allergic reaction may include: if you are breastfeeding • to treat any other conditions • shortness of breath You may need to read it again. other than eczema and • wheezing or difficulty breathing dermatitis unless advised by your doctor. • swelling of the face, lips, tongue What EUMOVATE is or other parts of the body Do not use EUMOVATE on used for • rash, itching or hives on the skin children under the age of 12

Do not use EUMOVATE on: years except on the advice of a EUMOVATE is used to treat doctor. eczema and dermatitis. It can help • cuts or open wounds you to control patches of dry, red, • infected skin itchy, flaky or inflamed skin caused Do not use the cream on the by eczema and dermatitis. • inflamed skin near ulcers wrong skin conditions. It could make it worse. Do not use EUMOVATE to treat: EUMOVATE contains clobetasone butyrate. Clobetasone butyrate is a • rosacea (skin condition of the If you are not sure what is causing topical corticosteroid. It is used to face where the nose and cheeks your skin problem, ask your control inflammation on the skin. are unusually red) pharmacist or doctor.

• acne, spots or pimples EUMOVATE works to stop the Do not give EUMOVATE to anyone skin’s over-reaction to the triggers • pruritis (itching) with or without else, even if they have similar symptoms to you. that cause skin flare ups. It rash suppresses the inflammation that • causes eczema or dermatitis. perioral dermatitis EUMOVATE cream base also has Do not use EUMOVATE after the moisturising properties. expiry date printed on the pack 1

or if the packaging is torn or • other corticosteroid is not meant to treat large shows signs of tampering. medicines which may areas. If it has expired or is damaged, include some eczema return it to your pharmacist for creams, asthma inhalers, • disposal. tablets, injections, nasal Don’t cover the treated patch of sprays, and eye or nose skin with anything (bandages, If you are not sure whether you drops. dressings, gloves or plastic should start using this medicine, • ritonavir (antiviral medicine) wrap). It can cause more of talk to your doctor or and itraconazole (antifungal the medicine to pass through pharmacist. agent) the skin.

These medicines may affect the How to use it Before you start to use way EUMOVATE works. EUMOVATE Adults or children over 12 years Your doctor and pharmacist have of age: Tell your doctor or pharmacist if more information on medicines to • Use the cream twice a day for you have allergies to any other be careful with or avoid while using up to 7 days medicines, foods, preservatives this medicine. • Wash your hands and dry them or dyes • Squeeze out the correct amount of cream to cover the Tell your doctor or pharmacist if How to Use affected area onto your index you are pregnant or intend to finger. The picture above gives become pregnant or are EUMOVATE you an idea of how much to breastfeeding. You should not use. use EUMOVATE if you are Follow all directions given to you • Gently rub cream onto the pregnant or may be pregnant or by your doctor or pharmacist patch of skin you are treating. if you are breastfeeding unless carefully. • Wash your hands again (unless advised by your doctor. it is your hands you are They may differ from the treating). Your doctor or pharmacist will information contained in this leaflet. discuss the possible risks and Be especially careful not to get the benefits of using EUMOVATE If you do not understand the cream in your eyes. during pregnancy or breastfeeding. instructions on the carton or in this leaflet, ask your doctor or Use in children under 12 years of Tell your doctor or pharmacist if pharmacist for help. age only on the advice of a doctor. you have kidney or liver problems. Don’t cover the treated patch of How much to use skin with anything (bandages, If you have not told your doctor dressings, gloves or plastic pharmacist about any of the The minimum amount of cream wrap). It can cause more of the above, tell him/her before you should be used for the minimum medicine to pass through the start using EUMOVATE. amount of time. Do not use for skin.

more than 7 days.

When to use it Taking other medicines • Squeeze out the cream along the top of your index finger Tell your doctor or pharmacist Use your medicine at about the (see picture). same time each day. about any other medicines you • From the crease in the finger, are taking including medicines squeeze the cream halfway to Using it at the same time each day that you buy without a your fingertip. This will cover a will have the best effect. It will also prescription, in a pharmacy, patch of skin the same size as help you remember when to use it. supermarket or health food the palm of your hand. shop. • Use the fingertip unit as a

guide. For smaller areas, use How long to use it Do not use other corticosteroids a smaller amount. This cream (like hydrocortisone) on the skin Use EUMOVATE twice a day for up while you are using this cream. You would be doubling the dose. to 7 days. Do not use for more than 7 days except on the advice of Some medicines and a doctor. EUMOVATE may interfere with each other. These include: If you forget to use it 2

If you become pregnant while doctor for advice. Do not keep on If you forget to use EUMOVATE using this medicine, tell your using it. or miss an application, use it doctor or pharmacist If your skin gets worse or it does when you remember. immediately. not improve within a week, stop Do not try to make up for missed If you experience blurred vision using the cream and see your applications by using the cream or other visual disturbances, doctor. more often as this may increase the speak to your doctor. chance of you getting a side effect. If your skin condition clears up If your rash/ irritation gets better in less than a week, stop using but then comes back tell your If you have any questions about the cream. Think about emollient doctor or pharmacist. this, ask your doctor or (moisturising) products to help stop Don’t treat the same patch more pharmacist. it coming back. than twice without taking advice

from your doctor. If you have trouble remembering Skin specialists often advise people when to use your medicine, ask with eczema or dermatitis to use It is possible that you are treating your doctor or pharmacist for some emollient (or moisturising) skin the wrong skin condition or that hints. products, including creams and your skin may still be reacting to bath oils, to keep moisture in the something that it is coming in skin. This can make your skin If you use too much contact with. Some of the common (overdose) more resistant to flare ups. Avoid triggers are: using soap and heavily scented • Ear rings or studs – especially products. Ask your doctor or If you use a bit too much of the gold-plated ear rings pharmacist for further information. cream by mistake, don’t worry • Other jewellery but try to keep to the fingertip • Coins Things you must not do unit. Using corticosteroids on • Watch buckles, metal straps or the skin continuously over many the metal back of a watch weeks or months can cause skin • Metal studs or fastenings on Do not use EUMOVATE to treat thinning and permanent skin jeans, bras or underwear any other complaints unless damage. your doctor tells you to. All of these may have a metal in Do not give your medicine to If you or anyone swallow them called nickel that is a very EUMOVATE; common trigger. If you react badly anyone else, even if they have Immediately telephone your to nickel, all of the triggers in the list the same condition as you. doctor or Poisons Information could be a problem. Centre for advice (in Australia telephone 13 11 26, in New Other common triggers include Side effects Zealand telephone 0800 764 766) rubber and pine tree sap, which are or go to Accident & Emergency used in things we touch every day. Tell your doctor or pharmacist as at your nearest hospital, even if You might find triggers: soon as possible if you do not there are no signs of discomfort feel well while you are using or poisoning. You may need • In the home: such as plasters, EUMOVATE. urgent medical attention. furniture polish, varnishes,

rubber gloves or elastic in This medicine helps most people

clothes. with eczema and dermatitis, but it While you are using • In substances you use at may have unwanted side effects in work: like glues, oils, lubricants a few people. This cream is very EUMOVATE or cement. unlikely to cause any problems as • In the garden: certain plants long as you follow the advice in this Things you must do and weeds, gardening gloves. leaflet.

Inform any other doctors, Even if it is not practical to avoid All medicines can have side effects. dentists or pharmacists who are triggers, there are often practical Sometimes they are serious, most treating you that you are using steps you can take to minimise of the time they are not. You may EUMOVATE. possible irritation. need medical attention if you get

some of the side effects. If you are about to be started on EUMOVATE is meant to control any new medicine, remind your skin conditions that improve doctor or pharmacist that you within a week of treating Do not be alarmed by the are using EUMOVATE. yourself. If you think you need following lists of side effects. further treatment after that, see a You may not experience any of them. 3

The following symptoms may Disposal Ask your doctor or pharmacist to occur with use in children: answer any questions you may • delayed weight gain If your doctor or pharmacist tells • have. slow growth you to stop using EUMOVATE or the medicine has passed the If your skin gets worse during Other side effects that may show expiry date, ask your pharmacist treatment, you may have a skin up in blood tests or when your what to do with any medicine infection or a trigger you have not doctor gives you a medical that is left over. recognised or even an allergy to examination: the cream. • a decrease in the level of the hormone cortisol in your blood Product Description Stop using the cream and see your • high blood pressure doctor as soon as possible. • cloudy lens in the eye (cataract) What EUMOVATE looks • Tell your doctor or pharmacist if increased pressure in the eye like (glaucoma) you notice any of the following: • weakening of the bones EUMOVATE is a smooth white • rash through gradual loss of mineral cream for topical use. • itch (osteoporosis). Additional tests may be needed after your EUMOVATE is available in tubes • local skin burning medical examination to confirm containing 15 g* and 30 g of cream. • skin thinning if you have this condition * This pack size is marketed in New • increased blood sugar levels Zealand only. • skin bleaching or increased skin • glucose in the urine. pigmentation and hair disorders Australia only: A 5 g sample tube is Worsening of eczema or dermatitis After using EUMOVATE also available from your physician symptoms has also been reported. only.

Other side effects not listed above Storage Ingredients may also occur in some people. Keep your cream in the pack The active ingredient in Using more than the correct until it is time to use it. EUMOVATE is clobetasone amount of cream may cause butyrate. It is present at a changes to your skin e.g. concentration of 0.05%w/w. thinning or allow the active Keep your medicine in a cool dry ingredient to pass through the place where the temperature The inactive ingredients are: ° skin and affect other parts of the stays below 25 C. • Glycerol body. • Glyceryl monostearate Do not store EUMOVATE or any • Cetostearyl alcohol This is not a problem if you use other medicine in the bathroom • Beeswax substitute 6621 the right amount of cream and or near a sink. • Arlacel 165 for the correct period of time. • Do not leave EUMOVATE or any Dimethicone 20 • The following are very rare side other medicines in the bathroom Chlorocresol effects and may occur if you use or near a sink. Do not leave it • Sodium citrate more than the correct amount of on a window sill or in the car. • Citric acid monohydrate cream or for longer than • Water-purified recommended: Heat and dampness can destroy some medicines. If you use more than the correct Where to go for more amount of cream or for longer Keep EUMOVATE where children information than recommended you may cannot reach it. experience: A locked cupboard at least one- If you have any questions about • increased weight your treatment with EUMOVATE, and-a-half metres above the • moon face or rounding of the ask your doctor or pharmacist. face ground is a good place to store • obesity medicines. Or you may call the toll-free • changes to the colour of your INFOLINE: skin Do not use the medicine after the • increased body hair expiry date on the tube end or In Australia: 1800 033 109 carton. In New Zealand: 0800 808 500 4

Manufacturer and supplier

EUMOVATE is made in the UK and supplied:

In Australia by:

GlaxoSmithKline Australia Pty Ltd Level 4 436 Johnston Street Abbotsford Victoria 3067

In New Zealand by:

GlaxoSmithKline NZ Ltd Downtown Auckland

Trade marks are owned by or licensed to the GSK group of companies.

This leaflet was prepared on 19 September 2018.

AUST R 178288

Version 9.0