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Document: leaflet MAH BRAND_PLPI 19488-0117 change

• leaflet MAH BRAND_PLPI 19488-0117
• leaflet MAH BRAND_PLPI 20636-2398

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S117 LEAFLET Elocon 20160310

PACKAGE LEAFLET: INFORMATION FOR THE USER ELOCON SCALP LOTION (mometasone furoate)

Your medicine is known as the Elocon Scalp Lotion but will be referred to as Elocon throughout the following patient information 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 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 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 using this medicine.

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

3. HOW TO USE ELOCON

Always use Elocon exactly as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure.

Use in 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).

•    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 can be wet or dry when 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.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

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

What Elocon contains

•    Each 1ml of lotion contains 0.1%w/w of the active ingredient, mometasone furoate.

•    Elocon also contains the following inactive ingredients: isopropyl alcohol, propylene glycol, hydroxypropyl cellulose, sodium phosphate monobasic monohydrate, phosphoric acid and purified water.

What Elocon looks like and contents of the pack

Elocon is a colourless solution.

Elocon is available in bottles containing 30ml.

Product Licence holder

Procured from within the EU and repackaged by the Product Licence holder: S&M Medical Ltd, Chemilines House, Alperton Lane, Wembley, HA0 1DX.

Manufacturer

This product is manufactured by Famar A.B.E., 49th km National road Athens -Lamia, Avlobnas, Attiki, Greece.

| POM|    PL: 19488/0117

Leaflet revision date: 10 March 2016

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

S117 LEAFLET Elocon 20160310

S117 LEAFLET Mometasone 20160310

PACKAGE LEAFLET: INFORMATION FOR THE USER MOMETASONE FUROATE 0.1%w/w SCALP LOTION

Your medicine is known as the Mometasone Furoate 0.1%w/w Scalp Lotion but will be referred to as Mometasone Furoate throughout the following patient information leaflet.

Children

Mometasone Furoate is not recommended for children under the age of 2.

Other medicines and Mometasone Furoate Scalp Lotion

Tell your doctor, pharmacist or nurse if you are using, have recently used or might use any other medicines.

What is in this leaflet:

1.    What Mometasone Furoate is and what it is used for

2.    What you need to know before you use Mometasone Furoate

3.    How to use Mometasone Furoate

4.    Possible side effects

5.    How to store Mometasone Furoate

6.    Contents of the pack and other information

1. WHAT MOMETASONE FUROATE IS AND WHAT IT IS USED FOR

Mometasone Furoate 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, Mometasone Furoate 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 MOMETASONE FUROATE

Do not use Mometasone Furoate 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 Mometasone

Furoate:

•    If your scalp becomes irritated or sensitive after using Mometasone Furoate, you should stop using it and tell your doctor

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

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 using this medicine.

Mometasone Furoate Scalp Lotion contains propylene glycolstearate, which can cause skin irritation.

3. HOW TO USE MOMETASONE FUROATE

Always use Mometasone Furoate exactly as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure.

Use in Children

•    Mometasone Furoate 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 Mometasone Furoate

You should always follow these instructions when using Mometasone Furoate:

•    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).

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

How to use Mometasone Furoate

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

•    The hair can be wet or dry when applying the lotion to the scalp.

If you use more Mometasone Furoate 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 Mometasone Furoate

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 Mometasone Furoate

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, Mometasone Furoate 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 Mometasone Furoate:

•    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

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Mometasone Furoate contains

•    Each 1ml of lotion contains 0.1%w/w of the active ingredient, mometasone furoate.

•    Mometasone Furoate also contains the following inactive ingredients: isopropyl alcohol, propylene glycol, hydroxypropyl cellulose, sodium phosphate monobasic monohydrate, phosphoric acid and purified water.

What Mometasone Furoate looks like and contents of the pack

Mometasone Furoate is a colourless solution.

Mometasone Furoate is available in bottles containing 30ml.

Product Licence holder

Procured from within the EU and repackaged by the Product Licence holder: S&M Medical Ltd, Chemilines House, Alperton Lane, Wembley, HA0 1DX.

Manufacturer

This product is manufactured by Famar A.B.E., 49th km National road Athens -Lamia, Avlobnas, Attiki, Greece.

| POM|    PL: 19488/0117

Leaflet revision date: 10 March 2016

S117 LEAFLET Mometasone 20160310

5. HOW TO STORE MOMETASONE FUROATE

•    KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

•    Do not store above 25°C.

•    Do not use after the expiry date printed on the carton label or bottle.

•    If your doctor tells you to stop using the medicine, please take them back to the pharmacist for safe disposal. Only keep the medicine if your doctor tells you to.

•    If the medicine become discoloured or show any other signs of deterioration, you should seek the advice of 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.