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PACKAGE LEAFLET: INFORMATION FOR THE USER

Fucidin® Suspension

fusidic acid

In this leaflet:

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

2.    Before you take Fucidin® Suspension

3.    How to take Fucidin® Suspension

4.    Possible side effects

5.    How to store Fucidin® Suspension

6.    Further information

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

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

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

Fucidin® Suspension is used to treat infections such as:

•    Infections of the skin and wounds

•    Infections of the blood such as septicaemia

•    Infections of the bone and heart tissue

•    Infections of the lungs such as pneumonia

•    Infections connected with the condition cystic fibrosis.

2.    BEFORE YOU TAKE FUCIDIN® SUSPENSION

Do not take Fucidin^® Suspension

•    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.

•    If you know that you have any sugar intolerance. You may have inherited this condition from someone else in your family.

Take special care with Fucidin^® Suspension

Before you take Fucidin® Suspension, tell your doctor:

•    If you are taking statins (medicines to lower blood cholesterol).

•    If you have problems with your liver

•    If you have recently been jaundiced.

When you are taking Fucidin®

Suspension your doctor may take regular blood tests in patients on high doses, with liver or bile problems, taking the medicine for a long time or taking other medicines that affect the liver.

If you are concerned that your treatment is not as effective as it should be, tell your doctor. As with any antibiotic treatment, long term or repeated use may increase the risk of developing antibiotic resistance.

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.

•    Do not take statins (medicines to lower blood cholesterol) while using this medicine.

You must tell your doctor or pharmacist if you are taking any of the following medicines:

•    Other antibiotics, such as lincomycin and rifampicin.

•    Oral anti-coagulants (medicines to "thin" your blood). You may be likely to bleed more easily. Your doctor may need to change your dose.

•    Medicines to lower blood cholesterol, such as statins. This may lead to muscle weakness, tenderness or pain. Also see section 4 of this leaflet.

•    Ritonavir or saquinavir, medicines used to treat HIV.

•    Ciclosporin. This medicine is used to reduce the body's immune reactions.

Pregnancy and breast-feeding

Please ask your doctor or pharmacist for advice before taking Fucidin^®

Suspension:

•    If you are pregnant, or think you are pregnant

•    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^® Suspension Fucidin® Suspension contains:

•    Sodium benzoate. This may increase the risk of jaundice in newborn babies.

•    Glucose. This is a type of sugar. If you cannot tolerate any sugar (sometimes called sugar intolerance), contact your doctor before taking this medicine. Your medicine contains 1.25 gram (g) glucose in each 5 millilitres (ml). This should be taken into account in patients with diabetes mellitus.

•    Sorbitol. This is a type of sugar. If you cannot tolerate any sugar (sometimes called sugar intolerance), contact your doctor before taking this medicine.

•    Sodium. Your medicine contains 2 milligrams (mg) sodium in each ml. This should be taken into consideration if you are on a controlled sodium diet.

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

3.    HOW TO TAKE FUCIDIN® SUSPENSION

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

How much Fucidin® Suspension to take

Your doctor will tell you how much Fucidin® Suspension to take or to give to your child and how many times each day to take it.

You should take the medicine at equally spaced times in the day.

Shake well before use.

Adults

The usual dose is 15 ml three times each day.

Children

The usual dose for a child:

•    Under 1 year is 1 ml/kg bodyweight each day. This dose will be divided into 3 equal doses.

•    Between 1-5 years is 5 ml three times each day

•    Between 5-12 years is 10 ml three times each day.

If you take more Fucidin^® Suspension than you should

Tell your doctor straight away. You may need to stop taking this medicine.

If you forget to take Fucidin^® Suspension

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

If you stop taking Fucidin^® Suspension

It is very important to take all the medicine that your doctor has told you to take. You must finish this medicine even if you feel better. You must do this because otherwise your infection may come back.

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

4.    POSSIBLE SIDE EFFECTS

Like all medicines, Fucidin® Suspension can cause side effects, although not everybody gets them. Between 1-2 people out of 10 may experience side effects with Fucidin® Suspension, but most of these are stomach upsets and depend on the dose.

Serious side effects:

Rare (affects less than 1 in 1,000 people): allergic reaction. You must get urgent medical help if you have any of the following symptoms:

•    You have difficulty breathing

•    Your face or throat swell

•    Your skin develops a severe rash.

Number of people affected not known: You must get urgent medical help if you have any of the following symptoms.

You may be developing a condition called rhabdomyolysis:

•    You develop muscle weakness

•    You develop muscle pain

•    You develop muscle tenderness.

Number of people affected not known: problems with your liver or kidneys. You should tell your doctor straight away if you have any of the following symptoms:

•    Your skin or the whites of your eyes appear yellow

•    You are not passing water.

Number of people affected not known: the level of some cells in your blood may change. You should tell your doctor straight away if you have any of the following symptoms:

•    You develop any unexplained bruising or bleeding

•    You develop persistent or repeated mouth ulcers, sore throats or other infections.

Other possible side effects:

Common (affect less than one in 10 people):

Dizziness, drowsiness, diarrhoea, nausea, vomiting, stomach upset, heartburn.

Uncommon (affect less than 1 in 100 people):

Headache, rash, itchy rash, itching, loss of appetite, feeling tired, weak or unwell.

Number of people affected not known:

Pale stools Dark urine

Upper right hand side stomach pain.

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

6. FURTHER INFORMATION

What Fucidin^® Suspension contains

•    The active ingredient is fusidic acid. Fucidin® Suspension contains 250 mg of fusidic acid in every 5 ml.

•    The other ingredients are acesulfame potassium, banana flavour, orange dry flavour, citric acid, disodium phosphate dihydrate, glucose liquid, hydroxyethylcellulose, methylcellulose, sodium benzoate, sorbitol and 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^® Suspension looks like and contents of the pack

Fucidin® Suspension is a white to off-white liquid.

Fucidin® Suspension comes in a bottle of 50 ml with a measuring cup.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

LEO Laboratories Limited,

Hurley, Berkshire SL6 6RJ, UK

Manufacturer: LEO Pharma A/S,

DK 2750 Ballerup, Denmark.

This leaflet was last revised in October 2013.

®Registered Trade Mark

5. HOW TO STORE FUCIDIN® SUSPENSION

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

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

•    This medicinal product does not require any special storage conditions.

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.