FUSIDIC ACID 2% CREAM

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 or pharmacist.

•    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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

WHAT IS IN THIS LEAFLET:

1.    What Fusidic Acid is and what it is used for

2.    What you need to know before you use Fusidic Acid

3.    How to use Fusidic Acid

4.    Possible side effects

5.    How to store Fusidic Acid

6.    Contents of the pack and other information

Ofl WHAT FUSIDIC ACID IS AND WHAT IT IS USED FOR

The active ingredient of Fusidic Acid is fusidic acid. This is an antibiotic (this means that it kills bacteria that cause infections).

Fusidic Acid should be used on the skin. The cream is used for the local treatment of skin infections caused by bacteria that are sensitive to fusidic acid (especially staphylococcus infections) such as impetigo (a weeping, crusty and swollen patch of skin), folliculitis (inflammation of one or more hair follicles), sycosis barbae (infection of the bearded skin), paronychia (infection of the tissue surrounding a fingernail or toenail) and erythrasma (infection with brown, scaly skin patches, especially in the folds of the body). It is also used to treat infected dermatitis (inflammation of the skin), spots, cuts and grazes.

WHAT YOU NEED TO KNOW BEFORE YOU USE FUSIDIC ACID

Do not use Fusidic Acid

• if you are allergic (hypersensitive) to fusidic acid or any of the other ingredients of this medicine (listed in section 6).Therefore, always tell your doctor which medicines or other substances you are allergic to.

Warnings and precautions

Talk to your doctor or pharmacist before using Fusidic Acid

• if you use Fusidic Acid on the face. The cream should not be applied in or near the eye because it can lead to a prickling feeling in the eye • if you use the cream for a long time or in large amounts as it may make the chance of getting any side effects higher. Also your skin may get more sensitive to the cream.

Please tell your doctor if one of the above warnings applies to you or has applied to you in the past.

Other medicines and Fusidic Acid

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

There is no known effect of Fusidic Acid with other medicines.

Pregnancy and breast-feeding

Pregnancy:

You need to discuss your specific circumstances with your doctor to weigh up the overall risks and benefits of using this medicine.

You should only use this medicine during pregnancy if your doctor thinks that you need it.

Breast-feeding:

Using Fusidic Acid topically and breast-feeding is unlikely to harm your baby. However, it is not recommended to apply Fusidic Acid to the breast whilst breast-feeding.

You should talk to your doctor if you have any concerns using this medicine whilst breast-feeding.

Ask your doctor or pharmacist for advice before taking any medicine!

Driving and using machines

This cream does not affect your ability to drive or operate machinery.

Fusidic Acid contains

butylhydroxyanisole, cetyl alcohol and potassium sorbate which may cause local skin reactions (e.g. contact dermatitis). Butylhydroxyanisole may also cause irritation to the eyes and mucous membranes.

^ HOW TO USE FUSIDIC ACID

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

Dosage

Your doctor will tell you how much Fusidic Acid you should use.

Adults and children

Usually a small amount of cream is applied to the infected skin three or four times each day. If your doctor advises you to use a sterile bandage or dressing, you can usually reduce the number of applications.

A nappy on a baby may act as a dressing. Follow the advice of your doctor.

If you think that the effect of Fusidic Acid is too strong or too weak, ask your doctor or pharmacist for advice.

How to apply Fusidic Acid

Fusidic Acid should be applied to the skin. Do not swallow it.

1.    Always wash your hands before you use the cream

2.    Remove the cap

3.    Check that the seal is not broken before you use the cream for the first time

4.    Push the spike in the cap through the seal of the tube

5.    Rub the cream gently on the skin

6.    If you use the cream on your face be careful to avoid your eyes

7.    Always wash your hands after using the cream, unless you are using the cream to treat your hands.

If you accidentally get any cream in your eye, wash it out with cold water straight away. Then rinse your eye with eye wash 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.

Duration of treatment

The duration of the treatment will be decided by your doctor. Treatment is usually 1 to 2 weeks, although it may be longer. This depends on the type of infection and the result of the treatment. Take special care if you use the cream for a long time or in large amounts, because then there is a higher chance of getting side effects. Therefore, always follow the advice of your doctor.

If you use more Fusidic Acid than you should

If you apply too much or accidentally swallow Fusidic Acid, it is unlikely to cause any harm.

Generalised effects (e.g. jaundice) may be caused if you apply too much of this medicine, in particular on wide skin surfaces. However, no cases of overdose have been reported so far.

However, if you notice any effect or are worried, contact your doctor or pharmacist. You should contact the doctor if Fusidic Acid is accidentally swallowed by an infant.

If you forget to use Fusidic Acid

If you forget to use the cream, apply the usual amount of Fusidic Acid as soon as you remember. Do not apply a double dose to make up for a forgotten dose.

If you stop using Fusidic Acid

Always use Fusidic Acid for duration directed by your doctor. Speak to your doctor if unsure. If you stop using Fusidic Acid prematurely, it is possible that the skin infection returns or does not cure.

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

POSSIBLE SIDE EFFECTS

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

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.

The frequency of occurrence of side effects is as follows:

Very common: Affects more than 1 in 10 users

are various skin reactions and in

particular application site reactions.

Uncommon

•    Itching (pruritis)

•    Rash

•    Skin sensitivity reactions (contact dermatitis and eczema)

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

Rare

•    Inflammation of the eye (conjunctivitis)

•    Hives

•    Blistering of the skin

• Angioedema (sudden swelling in the skin and mucous membranes (for example throat and tongue), breathing problems and/or itching and skin rash, often the symptoms of an allergic reaction) Immediately contact your doctor or pharmacist if this occurs.

Reporting of side effects

If you get any side effects talk to your doctor or pharmacist. 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.

HOW TO STORE FUSIDIC ACID

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 carton or the tube after "EXPYThe expiry date refers to the last day of that month.

Do not store above 25°C.

Discard the tube after 4 weeks of first opening the tube even if there is still some cream left in it.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

©I CONTENTS OF THE PACK AND OTHER INFORMATION

What Fusidic Acid contains

• The active substance is fusidic acid 2%. Each gram of cream contains 20 mg fusidic acid

• The other ingredients are

butylhydroxyanisole (E320), cetyl alcohol, glycerol (E422), liquid paraffin, potassium sorbate (E202), polysorbate 60 (E435), white soft paraffin, hydrochloric acid for pH adjustment, purified water. Some of these ingredients can cause a skin reaction, see section 2 of this leaflet.

What Fusidic Acid looks like and contents of the pack

Fusidic Acid is a white to off-white cream, and is available in an aluminium tube with HDPE screw cap.

Pack sizes: 15 gram and 30 gram.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

TEVA UK Limited, Eastbourne,

BN22 9AG, UK

Manufacturer

Basic Pharma Manufacturing B.V., Burgemeester Lemmensstraat 352, Geleen, 6163 JT, The Netherlands

This leaflet was last revised in 10/2014.

PL 00289/1849

30160-B 320 x 148 TEVA UK LIMITED    248989.02-GB