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Package leaflet: Information for the user

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IIIIIIIIIIIIIIIHII    Elocon® Ointment    llll III I Nil Hill II

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■ 1,1,1111,    MOMETASONE FUROATE    ||||11|11|||||

^MSD

Read all of this leaflet carefully before you start using this medicine because It contains Important Information for you.

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

•    If you have any further questions, ask your doctor, pharmacist or nurse.

•    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

•    If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See Section 4.

What is in this leaflet

1.    What Elocon is and what it is used for

2.    What you need to know before you use Elocon

3.    Elow to use Elocon

4.    Possible side effects

5.    How to store Elocon

6.    Contents of the pack and other 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.    What you need to know before you use Elocon Do not use Elocon:

•    if you are allergic (hypersensitive) to mometasone furoate or any of the other ingredients in this medicine (listed in section 6) or to other 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.

Warning and precautions

Talk to your doctor, pharmacist or nurse before using Elocon:

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

•    Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you maybe pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Elocon Ointment contains propylene glycolstearate

Elocon Ointment contains propylene glycolstearate, which can cause skin irritation.

3.    How to use Elocon

Always use Elocon exactly as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are not sure.

Use in children

Elocon is not recommended for children under the age of 2.

How much to use

Usually for adults and children aged 2 and above, a thin layer of Elocon Ointment should be gently rubbed into the affected area of skin once a day.

Before using Elocon

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.

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Dimensions (mm):    170mmx 265mm

Folding Size 170x23mm

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•    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 corticosteroids 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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom: Yellow Card Scheme at: www.mhra.gov.uk/yellowcard Malta: ADR Reporting at: www.medicinesauthority.gov.mt/adrportal

5.    How to store Elocon

The ointment should be stored between 2 and 30°C.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXR The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6.    Contents of the pack and other information What Elocon contains

•    The active substance is mometasone furoate 0.1 %w/w

•    The other ingredients are hexylene glycol: purified water; phosphoric acid; propylene glycol stearate; white bees wax; white soft paraffin.

What Elocon looks like and contents of the pack

The ointment is available in a tube containing 5, 15, 30, 45 and 100 g. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder

Merck Sharp & Dohme Limited,

Hertford Road, Hoddesdon, Hertfordshire, EN1 1 9BU, UK.

Manufacturer Schering-Plough Labo NV,

Heist-op-den Berg, Belgium.

This leaflet was last revised in August 2015.

PIL.EL0-0.14.UK.4434-IB QRD

© Merck Sharp & Dohme limited, 201 5. All rights reserved.

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