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ELOCON® CREAM (mometasone furoate)

Patient Information Leaflet

Read all of this leaflet carefully before you start using this medicine.

•    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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Elocon cream is and what it is used for

2.    Before you use Elocon cream

3.    How to use Elocon cream

4.    Possible side effects

5.    How to store Elocon cream

6.    Further information

1. What Elocon cream is and what it is used for

Elocon cream is one of a group of medicines called topical corticosteroids. It is classified as a "potent corticosteroid”.

These medicines are put on the surface of the skin to reduce the redness and itchiness caused by certain skin problems.

In adults and children, Elocon cream is used to reduce redness and itchiness caused by certain skin problems called psoriasis or dermatitis.

Psoriasis is a skin disease in which itchy, scaly, pink patches develop on the elbows, knees, scalp and other parts of the body. Dermatitis is a condition brought on by the skin reacting to outside agents e.g. detergents, causing the skin to become red and itchy.

2. Before you use Elocon cream

Do not use Elocon cream

•    if you are allergic (hypersensitive) to mometasone furoate, any of the other ingredients of Elocon cream, or to similar medicines.

•    on any other skin problems as it could make them worse especially

•    rosacea (a skin condition affecting the face)

•    acne

•    skin atrophy (thinning of the skin)

•    dermatitis around the mouth

•    genital itching

•    nappy rash

•    cold sores

•    chickenpox

•    shingles

•    warts

•    ulcerated skin

•    wounds

•    other skin infections

Ask your doctor or pharmacist if you are not sure.

Take special care with Elocon cream

•    if your skin becomes irritated or sensitive after using Elocon cream, you should stop using it and tell your doctor

Pregnancy and breast-feeding

You should tell your doctor if you are pregnant or breast-feeding, before you start using Elocon cream Important information about some of the ingredients of Elocon cream

Elocon cream contains stearyl alcohol, which can cause local skin reactions (e.g. contact dermatitis) and propylene glycolstearate, which can cause skin irritation.

3. How to use Elocon cream

Always use Elocon cream exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Elocon cream is not recommended for children under the age of 2. Usually for adults and children, a thin layer of Elocon cream should be gently rubbed into the affected area of skin once a day.

You should always follow these instructions when using Elocon cream:

•    Do not use the cream on your face for more than 5 days.

•    Do not apply the cream to children, on any part of their body, for more than 5 days.

•    Do not put the cream under your child's nappy, as this makes it easier for the active drug to pass through the skin and possibly cause some unwanted effects.

•    You should check with your doctor before covering the treated areas with a bandage or plaster. Treated areas on the face or in children should not be covered with a bandage or plaster.

•    You should not use a large amount of cream on large areas of the body for a long time (for example every day for many weeks or months).

•    Do not use in or around your eyes, including the eye-lids.

If you use more Elocon cream than you should

If you (or somebody else) accidentally swallow the cream, it should not produce any problems. However, if you are worried, you should see your doctor.

If you use the cream more often than you should, or on large areas of the body, it can affect some of your hormones. In children, this may affect their growth and development.

If you have not used the cream as you were told to do and have used it too often and/or for a long time, you should tell your doctor.

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If you forget to use Elocon cream

If you forget to use your cream at the right time, use it as soon as you remember, then carry on as before.

If you stop using Elocon cream

If you have been using Elocon cream for a long time and your skin problem seems to have got better, you should not suddenly stop using the cream. If you do, you may find that your skin becomes red and you may notice stinging or burning. To avoid this, you should speak to your doctor as he will gradually reduce how often you need to use the cream until you stop treatment altogether.

4. Possible side effects

Like all medicines, Elocon cream can cause side effects, although not everybody gets them.

A few people may find that they suffer from some of the following side effects after using Elocon cream:

•    allergic skin reactions

•    bacterial and secondary skin infections

•    acne

•    inflammation and/ or infection of the hair follicles

•    thinning of the skin

•    red marks with associated prickly heat

•    loss of skin colour

•    burning

•    stinging

•    itching

•    tingling

•    excessive hair growth

•    softening of the skin and stretch marks.

Other side effects that may occur with topical corticosteroids are dry skin, skin irritation, dermatitis, dermatitis around the mouth, and small dilated blood vessels.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

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: www.mhra.gov.uk/yellowcard.

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

5. How to store Elocon cream

•    Elocon cream should be stored between 2-30°C. Store in the manufacturer's original container.

•    Do not use after the expiry date printed on the carton or metal tube.

   KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN.

•    If your doctor tells you to stop using the cream, please take it back to the pharmacist for safe disposal. Only keep the cream if your doctor tells you to.

•    If the cream becomes discoloured or shows any other signs of deterioration, you should consult your pharmacist who will advise you what to do.

6. Further information

Your medicine is called Elocon cream. Each gram of cream contains 1 milligram of the active ingredient, mometasone furoate in a soft, white, smooth cream base.

Elocon cream also contains the following inactive ingredients:

Hexylene glycol, propylene glycolstearate, stearyl alcohol and ceteareth-20, titanium dioxide (E171), aluminium starch octenylsuccinate, white beeswax, soft white paraffin and purified water.

Elocon cream is available as a pack containing 30 grams of cream.

POM    PL No: 6464/1826

This product is manufactured by Schering-Plough S.p.A., Officina Farmaceutica, Comazzo (Lodi), Italy and is procured from within the EU and repackaged by the Product Licence holder:

Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR

Leaflet revision and issue date (Ref.) 07.02.2014

Elocon® is a registered trademark of the Schering Corporation