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PACKAGE LEAFLET: INFORMATION FOR THE USER

Fucidin® Cream

fusidic acid

In this leaflet:

1.    What Fucidin® Cream is and what it is used for

2.    Before you use Fucidin® Cream

3.    How to use Fucidin® Cream

4.    Possible side effects

5.    How to store Fucidin® Cream

6.    Further information

1.    WHAT FUCIDIN® CREAM IS AND WHAT IT IS USED FOR

Fucidin® Cream contains fusidic acid. It is a type of antibiotic.

Fucidin® Cream works by killing germs (bacteria) that cause infections.

Fucidin® Cream is used to treat conditions where the skin is infected by germs (bacteria), such as:

•    Impetigo (a weeping, crusty and swollen patch of skin)

•    Infected dermatitis (inflammation of the skin) and spots

•    Infected cuts and grazes.

2.    BEFORE YOU USE FUCIDIN® CREAM

Do not use Fucidin^® Cream

•    If you are allergic (hypersensitive) to fusidic acid.

•    If you are allergic (hypersensitive) to any of the other ingredients in your medicine. You can find a list of these ingredients in section 6 of this leaflet.

Take special care with Fucidin^® Cream

•    Take special care if you are going to use this medicine near your eyes or the eyes of a child.

•    If you use the cream over a long time or in large amounts it may make the chance of getting any side effects higher. Also your skin may get more sensitive to this medicine.

Taking other medicines

Please tell your doctor or pharmacist if you are taking, or have recently taken any other medicines. This includes any medicines which you have bought without a prescription.

Pregnancy and breast-feeding

Please ask your doctor or pharmacist for advice before using Fucidin® Cream:

•    If you are pregnant, or think you are pregnant.

You must not use your medicine for a long time or in large amounts. You must ask your doctor for advice.

•    If you are breast-feeding.

Tell your doctor if you become pregnant while using this medicine.

Driving and using machines

Usually your medicine will have very little effect on your ability to drive or use machines. Check with your doctor if you feel any side effect that may stop you from driving or using machines.

Important information about some of the ingredients of Fucidin^® Cream Fucidin® Cream contains:

•    Butylhydroxyanisole (E320). This may give you an itchy rash and inflammation on your skin where your medicine is used. This may also cause irritation to the eyes and mucous membranes (such as lips or genital area).

•    Cetyl alcohol. This may give you an itchy rash and inflammation on your skin where your medicine is used.

•    Potassium sorbate. This may give you an itchy rash and inflammation on your skin where your medicine is used.

Please ask your doctor if you are worried about any of the ingredients in this medicine.

3. HOW TO USE FUCIDIN® CREAM

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

How to put on Fucidin^® Cream This medicine is only for using on your skin or the skin of a child. Do not swallow it. Do not put it inside your body.

Remove the cap. Check the seal is not broken before you first use the cream. Then push the spike in the cap through the seal on the tube.

Always wash your hands before using Fucidin® Cream. Rub the medicine gently on the skin. If you use it on your face be careful to avoid your eyes.

Unless you are using the cream to treat your hands, always wash your hands after using Fucidin® Cream.

If you accidentally get any medicine in your eye, wash it out with cold water straight away. Then bathe your eye with eyewash if possible. Your eye may sting.

If you start to have any problems with your sight or your eye is sore, contact your doctor immediately.

How much Fucidin® Cream to use

Your doctor will tell you how much Fucidin® Cream to use.

Usually, you should use this medicine three or four times each day.

If you have been told to cover the skin with any dressings or bandages you may not need to use the medicine so often. A nappy on a baby may act as a dressing. Follow the advice of your doctor.

What to do if you use more Fucidin® Cream than you should

If you accidentally apply too much cream or a small quantity of the cream is accidentally swallowed, it is unlikely to cause any harm. If a larger quantity of the cream is accidentally swallowed or you are worried contact your doctor, pharmacist or A+E department for advice.

If you forget to use Fucidin^® Cream

If you forget to use this medicine, use it as soon as you remember. Then next use this medicine at the usual time.

If you have any further questions about using this medicine, please ask your doctor or pharmacist.

4.    POSSIBLE SIDE EFFECTS

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

Important side effects to look out for:

Rare (probably affect less than 1 in 1,000 people)

You must get urgent medical help if you have any of the following symptoms.

You may be having an allergic reaction:

•    You have difficulty breathing

•    Your face or throat swell

•    Your skin develops a severe rash.

Other possible side effects:

Uncommon side effects (probably affect less than 1 in 100 people)

•    Irritation at site of application (including pain, burning, irritation, stinging and skin redness)

•    Itching

•    Rash

•    Eczema

Rare side effects (probably affect less than 1 in 1,000 people)

•    Conjunctivitis

•    Hives

•    Skin swelling

•    Blistering of the skin

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

5.    HOW TO STORE FUCIDIN® CREAM

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

•    Do not use Fucidin® Cream after the expiry date on the carton. The expiry date is the last day of that month.

Medicines should not be thrown away in waste water or in household waste. Please ask your pharmacist how to throw away any medicine you do not need any more. If you do this you will help protect the environment.

6. FURTHER INFORMATION What Fucidin^® Cream contains

•    The active ingredient is fusidic acid 2%.

•    The other ingredients are butylhydroxyanisole (E320), cetyl alcohol, glycerol, liquid paraffin, polysorbate 60, potassium sorbate, purified water, all-rac-a-tocopherol, hydrochloric acid and white soft paraffin.

You can find important information about some of the ingredients in your medicine near the end of section 2 of this leaflet.

What Fucidin^® Cream looks like and contents of the pack

Fucidin® Cream is a white to off-white cream.

Fucidin® Cream comes in tubes of 15 g and 30 g.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

LEO Laboratories Limited,

Hurley, Berkshire SL6 6RJ, UK

Manufacturer:

LEO Laboratories Limited, Dublin 12, Ireland.

This leaflet was last revised in October 2013.

®Registered Trade Mark

LEO