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Elocon Cream

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FINAL DRAFT


COA


ELOCON CREAM

(mometasorve furoate) Patient Information Leaflet

| POM


Please read this Information leaflet about Elocon Cream carefully before you start using your cream. It contains all the information you should need to know. If you have any further questions or are not sure about anything, ask your doctor or pharmacist. Please keep this leaflet in a safe place, you may wish to refer to it again.

Your medicine is called Elocon Cream. The cream contains the active ingredient mometasone furoate 0.1% w/w in a smooth white cream base.

Elocon Cream also contains the following inactive ingredients: hexylene glycol, propylene glycolstearate. stearyt alcohol and cetearth-20, titanium dioxide, aluminium starch octenytsucdnate. white beeswax, white soft paraffin, phosphoric add and purified water.

Elocon Cream is available in a tube containing 30g.

Elocon Cream is one of a group of medidnes called topical corticosteroids. It is dassified as a "potent corticosteroid". This medidne is put on the surface of the skin to reduce the redness and itchiness caused by certain skin problems

•'    30984/0161

This product is manufactured by Schering-Plough S.A., Madrid, Spain and is procured from within the EC. Product Licence Holder and repackaged by: S.C.A.C. Ltd., Unit 2a, Bandeath Industrial Estate, Throsk, Stirling, FK7 7NP.

What to do If too much cream is used or if it is accidentally swallowed:

If you (or somebody else) accidentally swallows the cream, it

should not produce any undesirable effects. 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 followed the dosage instructions, or your doctors

advice and have used the cream too frequently and/or for a long time,

you should tell your doctor.

What to do if you forget to use your cream:

If you forget to use the cream at the right time, use it as soon

as you remember. Then go on as before. If you are not sure what lo do.

ask your doctor or pharmacist

After using the cream:

Side-Effects:

A few people may find that they suffer from some of the following side effects after using Elocon Cream: burning, stinging, itching, tingling, inflammation of the hair follicles, allergic skin reactions, loss of skin colour, excessive hair growth, thinning of the skin and red marks.

If you are worried by these or any other effects, you should tell your doctor or pharmacist.

Expiry Date:

Why you need to use this medicine:    Do not use after the expiry date printed on the tube or carton label.

Elocon Cream is used to reduce redness and itchiness caused by

certain skin problems called psoriasis or dermatitis.    Storage:

Before you use your medicine:

Make sure it is safe for you lo use Elocon Cream.

-    If you, or your child, have ever had an allergic reaction to Elocon Cream or any other similar medicines, you should not use it. You should tell your doctor so that he can give you. or your child, another medicine.

-    Do not put it on any other skin problems as it could make them worse especially rosacea (a skin condition affecting the face), acne, dermatitis around the mouth, genital itching, nappy rash, cold sores, chickenpox, shingles or other skin infections.

Ask your doctor or pharmacist if you are not sure.

-    You should tell your doctor If you are pregnant or breastfeeding, before you start using Elocon Cream

-    If your skin becomes irritated or sensitive after using Elocon Cream, you should stop using it and tell your doctor.

Elocon Cream should be stored between 2-30*C.

KEEP ALL MEDICINES OUT OF THE 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 lo.

If the cream becomes discoloured or shows signs of any deterioration, you should seek the advice of your pharmacist.

IMPORTANT:

This medicine is for YOUR use only. It can only be prescribed by a doctor. Never give it to anyone else. It may harm them even if their symptoms are the same as yours.

This leaflet does not contain complete information about your medicine. If you have any questions, or are not sure about anything, ask your doctor or pharmacist who has access lo additional Information ,    ■ :    ■ 1 ■    10.05.2011 DHH233S

Using your medicine:

Follow the doctor's Instructions and check the directions on the pharmacy label, which should tell you how to use it and when. If it does not or you are unsure about anything, consult your doctor or pharmacist Usually (or 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 lo 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 undesirable effects.

-    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).

Avoid getting the cream in your eyes.