S1493 LEAFLET Elocon 20160310 Other medicines and Elocon

PACKAGE LEAFLET: INFORMATION FOR USER ELOCON OINTMENT / MOMETASONE FUROATE 0.1% OINTMENT

(mometasone furoate)

Your medicine is known as above but will be referred to as Elocon throughout the following leaflet.

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.    How 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

• 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 may be 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.

•    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 via 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 store above 25^oC.

•    If Elocon becomes discoloured or shows other signs of deterioration, please speak to the pharmacist.

•    Do not use the Elocon after the date shown on the pack.

•    If you are told to stop using Elocon ake any tubes which you haven't finished back to your pharmacist for safe disposal. Only keep them if the doctor tells you to.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Elocon contains

•    Elocon Ointment contains 0.1% w/w of the active ingredient mometasone furoate.

•    The ointment also contains hexylene glycol, phosphoric acid, propylene glycolstearate, white beeswax, white soft paraffin and purified water.

What Elocon looks like and contents of the pack

Elocon Ointment is a smooth ointment

Elocon Ointment is available in tubes containing 30 or 60 grams. Product Licence holder

Procured from within the EU and repackaged by the Product Licence holder: S&M Medical Ltd, Chemilines House, Wembley,

HA0 1DX.

Manufacturer

This product is manufactured by Schering-Plough SA, Km36 Ctra. Nal. 1, San Agustin de Guadalix, Madrid, Spain. or

Schering-Plough Labo N.V., Industriepark, 30, B-2220 Heist-op-den-Berg, Belgium.

|POMl PL: 19488/1493

Leaflet revision date: 10 March 2016

Elocon is a registered trade mark of Schering Corporation, USA.

S1493 LEAFLET Elocon 20160310