Consumer medicine information

Fucidin Ointment

Sodium fusidate

BRAND INFORMATION

Brand name

Fucidin Topical Ointment

Active ingredient

Sodium fusidate

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Fucidin Ointment.

What is in this leaflet?

This leaflet answers some common questions about Fucidin® Ointment. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits it is expected to have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet.

You may need to read it again.

What Fucidin® Ointment is used for

Fucidin® Ointment contains an antibiotic, called sodium fusidate. This antibiotic is used to kill bacteria, especially those of the kind known as Staphylococci. (“Staph”)

Staphylococci are bacteria that can cause severe infections.

Fucidin® Ointment is made to be put directly on skin and wounds. It treats skin and wound infections, especially those caused by Staphylococci. Fucidin® Ointment does not work against infections caused by viruses and other bacteria, which are resistant.

NOTE: Sodium fusidate, and the related fusidic acid, are antibiotics that can also be given to you as a tablet.The brand name for these products is also “Fucidin.”

Your doctor may have prescribed Fucidin® Ointment for another reason. Ask your doctor why this medicine has been prescribed for you.

This medicine is not addictive.

This medicine is available only with a doctor’s prescription.

This medicine is not expected to affect your ability to drive a car or operate machinery.

In babies during the first month of life, sodium fusidate may cause serious side effects. Discuss with your doctor if Fucidin® Ointment is to be used to treat a baby.

Before you use Fucidin® Ointment

When you must not use it

Do not use this medicine if you have an allergy or have had an adverse reaction to:

  • any medicine containing sodium fusidate or fusidic acid.
  • any of the ingredients listed at the end of this leaflet (see Product Description).

Some of the symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin.

Do not use this medicine:

  • after 60 days of first opening the tube or expiry date printed on the pack whichever comes first, or
  • if the packaging is torn or shows signs of tampering.

Return the expired or damaged pack to your pharmacist for disposal.

If you are not sure whether you should start using this medicine, talk to your doctor.

Before you start to use it

Tell your doctor if you have a known allergy to Fucidin® Ointment, sodium fusidate, fusidic acid or any ingredients listed at the end of this leaflet.

Tell your doctor if you are pregnant, plan to become pregnant or are breast-feeding.

Your doctor can discuss with you the risks and benefits involved.

If you have not told your doctor about any of the above, tell him/her before you start taking this medicine.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may be affected by Fucidin® Ointment or may affect how well Fucidin® Ointment works. You may need different amounts of your medicines, or you may need to take different medicines.

Fucidin® Ointment applied on the skin will not generally interfere with other antibacterial treatment, for example antibiotic tablets or injections.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while using this medicine.

How to use Fucidin® Ointment

Follow all directions given to you by your doctor or pharmacist carefully.

They may differ from the information contained in this leaflet.

If you do not understand the instructions on the pack and/or tube, ask your doctor or pharmacist for help.

How much to use

  • without a covering dressing:
    usually apply two or three times daily.
  • with a protective dressing:
    usually one application daily is enough.

The average treatment period is seven days. Some infections may require longer treatment.

How to use it

Regarding the affected area of skin, ask your doctor or pharmacist:

  • how much Fucidin® Ointment to apply, and
  • how thickly to spread the Fucidin® Ointment.

Always wash your hands after applying Fucidin® Ointment, unless the area being treated is on the hand.

When to use it

Use Fucidin® Ointment at about the same time each day:
This ensures a steady antibiotic effect and helps you remember to use it.

How long to use it

Follow carefully all directions given to you by your doctor and the pharmacist.

These directions may differ from the information contained in this leaflet.

Continue using your medicine until your doctor tells you otherwise.

Do not stop using this medicine because you are beginning to feel better. If you do not complete the course of antibiotic treatment the infection may return.

If you do not understand the instructions on the pack, ask your doctor or pharmacist for help.

If you forget to use it

If it is almost time for your next dose of Fucidin® Ointment, skip the dose you missed and applyyour next dose when you are meant to.

Otherwise, apply it as soon as you remember, and then go back to applying your medicine as you would normally.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering to use your medicine, ask your doctor or pharmacist for some hints.

If you take too much (overdose)

Fucidin® Ointment is for use on the skin. It is not to be swallowed.

It is most unlikely that you would develop an overdose from the recommended use of Fucidin® Ointment on the skin. However, if anyone swallows a quantity of Fucidin® Ointment, immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26 in Australia) for advice, or go to Accident and Emergency at the nearest hospital. Do this even if there are no signs of discomfort or poisoning. The person who has swallowed the Fucidin® Ointment may need urgent medical attention.

While you are using Fucidin® Ointment

Things you must do

Tell your doctor immediately

  • If you get diarrhoea whileusing Fucidin® Ointment, or even if the diarrhoea occurs several weeks after Fucidin® Ointment has been stopped.

If you are about to be started on any new medicine, tell your doctor and pharmacist that you are using Fucidin® Ointment..

If you are going to have surgery, tell the surgeon or anaesthetist that you are using Fucidin® Ointment.

It may affect other medicines used during surgery.

If you become pregnant while using Fucidin® Ointment, tell your doctor immediately. If you are about to have any blood tests, tell your doctor that you are using Fucidin® Ointment as it may interfere with the results of some tests.

Things you must not do

Do not use Fucidin® Ointment to treat any other complaints unless your doctor tells you to.

Do not give your medicine to anyone else, even if they appear to have the same condition as you.

Do not stop using your medicine without checking with your doctor.

Things to be careful of

Be careful not to get Fucidin® Ointment in your eye, especially when you are treating your face or hands.

Fucidin® Ointment is not expected to cause you any problems with driving or operating machinery. However, as with many other medicines, Fucidin® Ointment may cause dizziness, tiredness or drowsiness in some people. If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous.

Side effects

Similarly to all medicines, Fucidin® Ointment can cause some side effects. If they occur, most are likely to be minor and temporary. However, some may be serious and require medical attention.

Tell your doctor or pharmacist if you have any unpleasant effects while you are using Fucidin® Ointment even if you do not think the effect is connected with the medicine or is not listed in this leaflet.

Stop applying Fucidin® Ointment and immediately contact your doctor or go to the Emergency Department at your nearest hospital if you notice any of the following:

  • severe and sudden onset of itching, redness, hives or a rash around the application area
  • nausea or vomiting
  • swelling of the face, lips, mouth, tongue or throat with breathing difficulties.

These are very serious side effects. If you have them you may have had a serious allergic reaction to Fucidin® ointment. All of these side effects are rare.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

  • Mild irritation or pain at the site of treatment
  • Pain in leg ulcers
  • Hypersensitivity (allergy) to sodium fusidate or fusidic acid or the ingredients of the ointment
  • Itching and discharge of the eyes (conjunctivitis)
  • gradual onset of itchiness, redness, rash, swelling or blistering of the skin

Tell your doctor if you notice anything that is making you feel unwell.

Other side effects not listed above may also occur in some people.

Do not be alarmed by this list of side effects. You may not experience any of them. Ask your doctor or pharmacist to answer any questions you may have.

After using Fucidin® Ointment

Keep the Fucidin® Ointment tube in the pack until required.

Storage

Store Fucidin® Ointment in a cool dry place where the temperature stays below 30°C.

Do not store this medicine or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car.

Heat and dampness can destroy some medicines.

Keep Fucidin® Ointment where children cannot reach it.

A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Do not use Fucidin® Ointment after 60 days of first opening the tube or the expiry date printed on the pack, whichever comes first.

Disposal

If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

Product description

What it looks like

Fucidin® Ointment is a translucent yellowish to white ointment.

Ingredients

Fucidin® Ointment contains as the active ingredient 2% w/w (20mg/g) of sodium fusidate. It also contains:

  • Cetyl alcohol
  • Wool fat
  • White soft paraffin
  • Liquid paraffin

This medicine does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.

Fucidin® Ointment is supplied in tube of 5g (physician sample) and 15g. Not all pack sizes may be marketed.

The Australian Registration Number is AUST R 12990.

This is not all the information available on Fucidin® Ointment. If you have any more questions or are unsure about anything, ask your doctor or pharmacist.

Supplier

Fucidin® Ointment is supplied in Australia by:

LEO Pharma Pty Ltd
Level 3, Tower 1,
25 Montpelier Road
Bowen Hills, QLD 4006

And manufactured by:
LEO Laboratories Ltd

This leaflet was prepared in September 2017.

Fucidin®, LEO and LEO/lion device are registered trademarks of LEO Pharma A/S.

BRAND INFORMATION

Brand name

Fucidin Topical Ointment

Active ingredient

Sodium fusidate

Schedule

S4

 

Name of the medicine

Sodium fusidate.

Excipients.

Cetyl alcohol, liquid paraffin, white soft paraffin and wool fat.

Description

Fucidin ointment contains sodium fusidate. Sodium fusidate is sodium ent-(17Z)-16α-(acetyloxy)- 3β,11β-dihydroxy-4β,8,14-trimethyl-18-nor-5β,10α-cholesta-17(20), 24-dien-21-oate; C31H47NaO6; a white or almost white crystalline powder, slightly hygroscopic, and freely soluble in water and ethanol (96 per cent). The CAS number is 751-94-0. pH 7.5 - 9.0. Partition coefficient: 2.6. pKa: 4.9.
Fucidin ointment is a translucent yellowish to white ointment.
Fucidin ointment contains sodium fusidate 20 mg/g in a neutral ointment base containing cetyl alcohol, liquid paraffin, white soft paraffin and wool fat.

Pharmacology

Fucidin, an antibiotic derived from Fusidium coccineum, exerts powerful antibacterial activity against a number of Gram positive organisms. Staphylococci, including the strains resistant to penicillin or to other antibiotics, are particularly susceptible to Fucidin.
Fucidin is highly diffusible, so that active concentrations are found even under crusted areas.

Indications

Skin lesions primarily and secondarily infected with staphylococci, e.g. abscesses, boils, furunculosis, impetigo, folliculitis, hidradenitis, pyoderma, sycosis barbae, otitis externa.

Contraindications

Infections caused by nonsusceptible organisms. Patients with hypersensitivity to the active substance or any of the excipients.

Precautions

When used for the treatment of facial lesions, care must be taken not to introduce ointment into the eyes as the excipients in the ointment may cause conjunctival irritation.
Bacterial resistance among Staphylococcus aureus has been reported to occur with the use of topical Fucidin. As with all antibiotics, extended or recurrent use of fusidic acid may increase the risk of developing antibiotic resistance.
Because of the potential to induce bacterial resistance, and thereby compromise the efficacy of systemically administered Fucidin, the use of Fucidin Topical should be avoided in closed settings e.g. hospitals.
Fucidin ointment contains cetyl alcohol and hydrous lanolin. These excipients may cause local skin reactions (e.g. contact dermatitis). Fucidin ointment contains butylhydroxytoluene (E321) which may cause local skin reactions (e.g. contact dermatitis) or irritation to the eyes and mucous membranes.

Use in pregnancy.

(Category C)
Fusidic acid may cause kernicterus in babies during the first month of life by displacing bilirubin from plasma albumin. Fusidic acid should be avoided when possible during the last month of pregnancy.

Adverse Effects

Mild irritation has been reported occasionally. The application of fusidic acid to deep leg ulcers has been associated with pain. Hypersensitivity reactions have been reported rarely.
Based on combined clinical data for Fucidin cream and Fucidin ointment, the most frequently reported adverse reactions during treatment are various skin reactions such as pruritus and rash, followed by various application site conditions such as pain and irritation.
Hypersensitivity and angioedema have been reported.
Adverse effects are listed by MedDRA system organ class (SOC) and the individual adverse effects are listed with the most frequently reported first. Within each frequency grouping, adverse effects are presented in the order of decreasing seriousness.
Very common ≥ 1/10; common ≥ 1/100 and < 1/10; uncommon ≥ 1/1,000 and < 1/100; rare ≥ 1/10,000 and < 1/1,000; very rare < 1/10,000.

Immune system disorders.

Rare: hypersensitivity.

Eye disorders.

Rare: conjunctivitis.

Skin and subcutaneous tissue disorders.

Uncommon: dermatitis (including contact dermatitis and eczema), rash (including erythematous, pustular, vesicular, macropapular and papular), pruritus, erythema.
Rare: angiodema, urticaria, blister.

General disorders and administration site conditions.

Uncommon: application site pain (including sensation of skin burning), application site irritation.

Dosage and Administration

Usually applied two to three times daily, with or without a covering dressing. When a protective dressing is used, one application daily will generally be sufficient.
The average period of treatment is 7 days. Severe and chronic infections may require longer treatment.
Treatment with Fucidin ointment will not interfere with other antibacterial therapy.

Overdosage

Overdosage has not been reported.

Presentation

Ointment (yellowish to white, translucent, neutral base), 2% (20 mg/g): 5 g*#, 15 g (aluminium tube with membrane and reclosable high density polyethylene screw cap. The tube has inner lacquer of epoxyphenol and sealant lacquer coating of acrylic acid ester copolymer in fold area).
*Physician sample.
#*Not currently marketed in Australia.

Storage

Store below 30°C.
In-use shelf life: 60 days.
Discard the tube after 60 days of first opening the tube.

Poison Schedule

S4.