Package leaflet: Information for the user

Fucidin® 20 mg/g ointment

sodium fusidate

• What is in this leaflet

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

2.    What you need to know before you use Fucidin® ointment

3.    How to use Fucidin® ointment

4.    Possible side effects

5.    How to store Fucidin® ointment

6.    Contents of the pack and other information

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

Fucidin ointment contains sodium fusidate. It is a type of antibiotic.

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

Fucidin ointment 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® ointment Do not use Fucidin ointment

•    If you are allergic to fusidic acid or sodium fusidate 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 ointment.

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

•    If you use the ointment 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® ointment

Tell your doctor or pharmacist 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 ointment contains

•    Lanolin (wool fat). This may give you an itchy rash and inflammation on your skin where your medicine is used.

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

•    Butylhydroxytoluene (E321). This may cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes (such as lips or genital area).

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

3. How to use Fucidin® ointment

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

How to put on Fucidin ointment

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 ointment. Then push the spike in the cap through the seal on the tube.

Always wash your hands before using Fucidin ointment. 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 ointment to treat your hands, always wash your hands after using Fucidin ointment.

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 ointment to use

Your doctor will tell you how much Fucidin ointment to use.

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

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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 ointment than you should

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

If you forget to use Fucidin ointment

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

5.    How to store Fucidin® ointment

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

*    Do not use this medicine after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month.

*    The tube should be discarded 3 months after first opening. Write the date you first opened the tube in the space provided on the carton.

*    This medicine does not require any special storage conditions.

Do not throw away 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.    Contents of the pack and further information

What Fucidin ointment contains

*    The active substance is sodium fusidate. 1 gram of Fucidin ointment contains 20 mg of sodium fusidate.

*    The other ingredients are cetyl alcohol, lanolin (wool fat), liquid paraffin, all-rac-a-tocopherol, butylhydroxytoluene (E321) 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 ointment looks like and contents of the pack

Fucidin ointment is a translucent yellow to white ointment.

Fucidin ointment comes in tubes of 3 g,

5 g, 10 g, 15 g, 25 g and 30 g. Not all pack sizes may be marketed.

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 November 2015.

©Registered Trade Mark

LEO

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