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Elocon Scalp Lotion

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Elocon® Scalp Lotion

Mometasone Furoate

Amsd

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 In this leaflet:

1.

2.

3.

4.

5.

6.

1.    WHAT ELOCON IS AND WHAT IT IS USED FOR


What ELOCON is and what it is used for

What you need to know before you use ELOCON

How to use ELOCON

Possible side effects

How to store ELOCON

Contents of the pack and other information


ELOCON Scalp Lotion 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 Scalp Lotion is used to reduce redness and itchiness caused by certain conditions affecting the scalp, 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:

Allergies (hypersensitivity) to mometasone furoate, or any of the other ingredients of this medicine (listed in section 6) or to other similar medicines Scalp problems as it could make them worse Chickenpox Shingles Warts

Other skin infections Ulcerated skin Wounds

Skin atrophy (thinning of the skin)

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 scalp becomes irritated or sensitive after using ELOCON, you should stop using it and tell your doctor

•    If you think that you have developed an infection on your scalp whilst using ELOCON, you should tell your doctor as he may need to give you another type of medicine to use.

Children

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

Other medicines and Elocon Scalp Lotion

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. Pregnancy and breast-feeding

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 using this medicine. Elocon Scalp Lotion contains propylene glycolstearate, which can cause skin irritation.

3.    HOW TO USE ELOCON

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Children

•    ELOCON is not recommended for children under the age of 2.

•    Do not use the lotion on your child’s scalp for more than 5 days.

•    Treated areas in children should not be covered with a bandage or plaster.

•    If you use the lotion on your child more often than you should, or on large areas of the body, it can affect some of their hormones, and    this    may    affect their growth and

development.

Before using ELOCON

You should always follow these instructions when using ELOCON:

•    This medicine should only be used on the scalp. Do not use it on any other part of your body.

•    You should check with your doctor before covering the treated areas with a bandage or plaster. Treated areas on the face should not be covered with a bandage or    plaster.

•    You should not use a large amount of lotion on large areas of the body for a long time (for example every day for many weeks or

months)    xxxxxx/xxxxxx-x

•    Do not use in or around the eyes, including eye-lids.

How to use ELOCON

•    Usually for adults and children, a few drops of ELOCON Scalp Lotion should be applied to the affected area of the scalp once a day and gently massage until the lotion disappears.

•    The hair should be dry before applying the lotion to the scalp.

If you use more ELOCON than you should

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

•    If you use the lotion 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 lotion 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 lotion 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 the lotion for a long time and your scalp problem seems to have got better, you should not suddenly stop using the lotion. If you do, you may find that your scalp becomes red and you may notice stinging and burning. To avoid this, you should speak to your doctor as he will gradually reduce how often you need to use the lotion 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 associate 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 Website: www.mhra.gov.uk/yellowcard

Malta: ADR Reporting, The Medicines Authority, Post-Licensing Directorate, 203 Level 3, Rue D’Argens, GZR-1368 Gzira Website: www.medicinesauthority.gov.mt, e-mail: postlicensing.medicinesauthority@gov.mt

5.    HOW TO STORE ELOCON

•    The lotion should be stored below 25 °C.

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

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

•    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.    FURTHER INFORMATION What ELOCON contains

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

•    The other ingredients are isopropyl alcohol, propylene glycol, hydroxypropyl cellulose, sodium dihydrogen phosphate dihydrate, phosphoric acid, purified water.

What ELOCON looks like and contents of the pack

The lotion is available in bottles containing 30 ml.

Marketing Authorisation Holder and Manufacturer The holder of the Marketing Authorisation is:

Merck Sharp & Dohme Limited,

Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU, UK.

The manufacturer is:

Schering-Plough Labo NV, Industriepark 30 B- 2220 Heist-op-den Berg, Belgium

This leaflet was last revised in March 2014.    mm/mm-x