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Hydrocortisone 2.5% Ointment

Document: leaflet MAH BRAND_PL 17736-0095 change

Efcortelan Cream

hydrocortisone

Read all of this leaflet carefully before you start using this medicine.

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

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

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

•    If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Efcortelan Cream is and what it is used for

2.    Before you use Efcortelan Cream

3.    How to use Efcortelan Cream

4.    Possible side effects

5.    How to store Efcortelan Cream

6.    Further information

1. What Efcortelan Cream is and what it is used for

Efcortelan Cream contains a medicine called hydrocortisone. It belongs to a group of medicines called steroids. It helps to reduce swelling and irritation.

Efcortelan Cream is used to:

•    help reduce the redness and itchiness of certain skin problems. These skin problems include eczema, dermatitis or insect bites

•    help reduce inflammation of the outer ear.

2. Before you use Efcortelan Cream

Do not use Efcortelan Cream:

•    if you are allergic (hypersensitive) to hydrocortisone, or any of the other ingredients of Efcortelan Cream (listed in Section 6)

•    to treat any of the following skin problems, it could make them worse:

-    viral infections, such as cold sores, herpes or chicken pox

-    fungal infections, such as ringworm, athletes foot or thrush

-    skin blisters or sores that are caused by an infection.

Do not use if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before using Efcortelan Cream.

Take special care with Efcortelan Cream

Check with your doctor or pharmacist before using your medicine if:

•    you are applying the cream under an airtight dressing, including a child's nappy. These dressings make it easier for the active ingredient to pass through the skin. It is possible to accidentally end up using too much cream.

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using this medicine.

Pregnancy and breast-feeding

Talk to your doctor or pharmacist before using this medicine if you are pregnant, might become pregnant or are breast-feeding.

3. How to use Efcortelan Cream

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

Using this medicine

•    You usually apply a small amount of Efcortelan Cream 2 to 3 times a day. This may be reduced as your skin begins to get better.

•    This cream is for use on your skin only.

•    Do not use on large areas of the body for a long time (such as every day for many weeks or months) - unless your doctor tells you to.

•    If you are applying the cream on someone else make sure you wash your hands after use or wear disposable plastic gloves.

•    If your skin problem does not improve, talk to your doctor.

Guidance on how to apply the cream

1    Wash your hands.

2    Gently rub the correct amount of cream into the skin until it has all disappeared. You can measure how much Efcortelan Cream to use with your fingertip. This picture shows one fingertip unit.

[Pictogram]

3    Unless you are meant to apply the cream to your hands as a part of the treatment, wash them again after using the cream.

For an adult

You should find that:

•    two fingertips of cream will cover both hands or one foot

•    three fingertips of cream will cover one arm

•    six fingertips of cream will cover one leg

•    fourteen fingertips of cream will cover the front and back of the body.

Do not worry if you find you need a little more or a little less than this. It is only a rough guide.

[Pictogram]

For a child

•    The smaller the child the less you will need to use.

•    A child of 4 years needs about a third of the adult amount.

•    A course of treatment for a child should not normally last more than 7 days - unless your doctor has told you to use it for longer.

If you apply Efcortelan Cream to your face

You should only apply the cream to your face if your doctor tells you to. The cream should not be used for too long as the skin on your face thins easily.

If you use more Efcortelan Cream than you should

If, by mistake on a few occasions you use more than you should, do not worry. If you apply a lot or if a lot is accidentally swallowed, it could make you ill. Talk to your doctor or go to hospital as soon as possible.

If you forget to use Efcortelan Cream

If you forget to apply your cream, apply it as soon as you remember. If it is close to the time you are next meant to apply it, wait until this time.

If you stop using Efcortelan Cream

If you use Efcortelan Cream regularly make sure you talk to your doctor before you stop using it.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Efcortelan Cream can cause side effects, although not everybody gets them.

STOP using Efcortelan Cream and tell your doctor as soon as possible if:

•    you find that your skin condition gets worse or becomes swollen during treatment. You may be allergic to the cream, have an infection or need other treatment.

Other side effects you may notice when using Efcortelan Cream include:

•    irritation or itching where the cream is applied

•    increased hair growth and changes in skin colour.

Side effects if you use Efcortelan Cream for a long time, you use a lot each time you apply it, or you apply it under an airtight dressing or a nappy:

•    thinning of your skin and it may also damage more easily

•    weight gain, rounding of the face and high blood pressure. These are more likely to happen in infants and children.

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 the Yellow Card Scheme at: 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 Efcortelan Cream

•    Keep out of the reach and sight of children.

•    Do not use Efcortelan Cream after the expiry date on the tube or carton (Exp). The expiry date refers to the last day of that month.

•    Do not store above 25°C.

•    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.

6. Further information

What Efcortelan Cream contains

•    The active ingredient is hydrocortisone.

Each 1 g contains:

-    5 mg of hydrocortisone (0.5% w/w),

-    10 mg of hydrocortisone (1% w/w), or

-    25 mg of hydrocortisone (2.5% w/w).

•    The other ingredients are:

chlorocresol, cetomacrogol 1000, cetostearyl alcohol, white soft paraffin, liquid paraffin, sodium acid phosphate, phosphoric acid, sodium hydroxide and purified water.

What Efcortelan Cream looks like and contents of the pack

Within each carton is a tube with a plastic screw cap, which contains 15 g, 30 g or 50 g of cream.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Chemidex Pharma Ltd, Chemidex House, Egham Business Village, Crabtree Road, Egham,

Surrey TW20 8RB.

Manufacturer

Puma Pharmaceuticals NV, Rijksweg 17, 2870 Puurs, Belgium.

This leaflet was last revised in

July 2014

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