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Elocon Cream

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Document: leaflet MAH BRAND_PLPI 15184-0130 change

Ref: 0130/060716/1/F


Elocon® Cream

(mometasone furoate)

Patient Information Leaflet

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.

Your medicine is called Elocon Cream but will be referred to as Elocon throughout the leaflet.

What is in this leaflet

What Elocon is and what it is used for

[2 What you need to know before you use Elocon

^ How to use Elocon

^4 Possible side effects

^5 How to store Elocon

[6 Contents of the pack and other information

What Elocon 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 What you need to know before you use Elocon

Do not use Elocon if you have any of the following:

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

Warnings 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

You should tell your doctor if you are pregnant or breast-feeding, before you start using Elocon.

^ How to use Elocon

Always use Elocon exactly as your doctor has told you. 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 Cream 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 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 eye-lids.

If you use more Elocon 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.

POM


If you forget to use Elocon

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

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 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 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

[6) Contents of the pack and other information

What Elocon contains

Elocon contains 0.1% w/w mometasone furoate as the active ingredient.

Inactive ingredients:

Your medicine also contains the following: hexylene glycol; purified water; phosphoric acid; titanium dioxide; aluminium starch octenylsuccinate; white wax; white soft paraffin and hydrogenated soybean lecithin

What Elocon looks like and contents of the pack

Elocon Cream is a white cream available in a metal collapsible tube with a white plastic cap.

Elocon Cream is available in tubes of 30g.

Manufacturer and Licence Holder

The cream is manufactured by Schering-Plough Labo N.V. Industriepark, 30 B-2220 Heist-op-den-Berg, Belgium, and is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.

Elocon is a registered trademark of Schering Corporation.

PL 15184/0130

Leaflet revision date: 06/07/16

Blind or partially sighted?

Is this leaflet hard to see or read? Phone Lexon (UK) Limited,

Tel: 01527 505414 for help.

^ How to store Elocon

Storing your medicine

•    Do not store above 25°C.

•    Keep out of the sight and reach of children.

•    Do not use an unopened tube of Elocon after the expiry date which is stated on the tube label and on the carton after "EXP”. The expiry date refers to the last day of that month.

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

•    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.

Ref: 0130/060716/1/B