PATIENT INFORMATION LEAFLET

ELOCON® Ointment

(mometasone furoate)

The name of your medicine is ELOCON Ointment but will be referred to as ELOCON throughout the remainder of this 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 get 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 is and what it is used for

2.    Before you use ELOCON

3.    How to use ELOCON

4.    Possible side effects

5.    How to store ELOCON

6.    Further information

1. WHAT ELOCON IS AND WHAT IT IS USED FOR

ELOCON Ointment 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 Ointment 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 Do not use ELOCON

•    if you are allergic (hypersensitive) to mometasone furoate, any of the other ingredients of ELOCON 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

•    if your skin becomes irritated or sensitive after using ELOCON, 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.

Important information about some of the ingredients of ELOCON

ELOCON contains propylene glycolstearate, which can cause skin irritation.

3. HOW TO USE ELOCON

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

You should always follow these instructions when using ELOCON:

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

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

•    Do not put the ointment 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 ointment 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 eye-lids

If you use more ELOCON than you should

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

If you use the ointment 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.

If you forget to use ELOCON

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

If you stop using ELOCON

If you have been using ELOCON for a long time and your skin problem seems to have got better, you should not suddenly stop using the ointment. 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 ointment until you stop treatment altogether.

4. POSSIBLE SIDE EFFECTS

Like all medicines, ELOCON 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:

•    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 corticosteriods are dry skin, skin irritation, dermatitis, dermatitis around the mouth, and small dilated blood vessels.

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

•    Keep out of the sight and reach of children.

•    Do not use ELOCON after the expiry date which is stamped on the pack.

•    Do not store above 25°C.

•    If your ointment becomes discoloured or show any signs of deterioration, you should seek the advice of your pharmacist.

•    Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6.    FURTHER INFORMATION What ELOCON contains:

The active substance in ELOCON is mometasone furoate 0.1%w/w.

The other ingredients are: hexylene glycol, propylene glycol stearate, white beeswax, white soft paraffin, phosphoric acid and purified water;

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What ELOCON looks like and contents of the pack

White, opaque ointment.

The ointment is available in a tube containing 30g.

Manufacturer

Schering-Plough Labo N.V.

Industriepark, 30 B-2220 Heist-op-den-Berg Belgium

Procured from within the EU and repackaged by:

Amimed Direct Ltd, Hendon London, NW9 6AQ.

Product Licence holder: Sam Pharma Ltd, Unit 20 Garrick Industrial Estate, Irving Way, Hendon, London, NW9 6AQ.

PL No: 33902/0432

This Leaflet was last approved in: 05/12/2014

ELOCON® is a registered trademark of Merck Sharp & Dohme Corp.

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