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Fucidin Cream

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FUCIDIN® CREAM

(fusidic acid)


PACKAGE LEAFLET: INFORMATION FOR THE USER

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.

What is in this leaflet

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

2.    What you need to know before you use Fucidin Cream

3.    How to use Fucidin Cream

4.    Possible side effects

5.    How to store Fucidin Cream

6.    Contents of the pack and 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.    What you need to know before you use Fucidin Cream

Do not use Fucidin Cream

■    If you are allergic to fusidic acid or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using 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.

Other medicines and Fucidin Cream

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.

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

■    You must not use your medicine for a long time or in large amounts.

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.

Fucidin Cream contains

■    Butylated hydroxyanisole (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 this medicine exactly as your doctor or pharmacist has told you. 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.

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 on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Important side effects to look out for:

Rare (may affect up to 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 (may affect up to 1 in 100 people)

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

■    Itching

■    Rash

■    Eczema.

Rare side effects (may affect up to 1 in 1,000 people)

■    Conjunctivitis

■    Hives

■    Skin swelling

■    Blistering of the skin.

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.aov.uk/vellowcard.

By reporting side effects, you can help provide more information on the safety of this medicine.

5.    How to store Fucidin Cream

■    Do not use after the expiry date printed on the carton or tube. The expiry date is the last day of that month.

■    There are no special storage instructions for Fucidin Cream.

■    KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN.

■    If your doctor tells you to stop using this medicine, take any remaining medicine back to the pharmacist for safe disposal. Only keep the medicine if your doctor tells you to.

■    If the cream becomes discoloured or shows signs of deterioration, you should seek the advice of your pharmacist.

■    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.    Contents of the pack and further information

What Fucidin Cream contains

Your medicine contains the active ingredient fusidic acid 2% W/W.

Fucidin Cream also contains the following inactive ingredients: butylated hydroxyanisole, cetyl alcohol, glycerol, liquid paraffin, potassium sorbate, polysorbate 60, white soft paraffin, purified water.

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 cream.

Fucidin Cream is supplied in tubes of 15g.

Manufacturer

Your medicine is manufactured by: Leo Laboratories Limited, 285 Cashel Road, Dublin 12, Ireland.

Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd, Kirk Sandall, Doncaster, DN3 1QR.

Product Licence holder: Landmark Pharma Ltd.,

7 Regents Drive, Prudhoe, Northumberland, NE42 6PX.

POM


PL No: 21828/0111

Leaflet revision date: 18.12.15

Fucidin® is a registered trademark of LEO Pharma A/S.

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