Consumer medicine information

What is in this leaflet?

Please read this leaflet carefully before you use BACTROBAN nasal ointment, or before helping someone else to use BACTROBAN nasal ointment.

This leaflet answers some common questions about BACTROBAN nasal ointment. It does not contain all of 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 expected benefits of you using BACTROBAN nasal ointment against the risks this medicine could have for you.

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

Keep this leaflet with the medicine. You may need to read it again.

What BACTROBAN nasal ointment is used for

BACTROBAN nasal ointment contains mupirocin (2% w/w) as the active ingredient.

Mupirocin belongs to a group of medicines called antibiotics. Antibiotics work by killing bacteria which can cause infection. BACTROBAN nasal ointment is used to remove bacteria, including the bacteria called 'Staphylococcus aureus' (golden staph.) from inside your nose. BACTROBAN nasal ointment is for use in your nose only.

Your doctor may have prescribed BACTROBAN nasal ointment for another reason.

There is no evidence that BACTROBAN nasal ointment is addictive.

Before you use BACTROBAN nasal ointment

When you must not use it:

Do not use BACTROBAN nasal ointment if you have an allergy to:

• any medicine containing mupirocin
• any of the ingredients listed at the end of this leaflet.

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 BACTROBAN nasal ointment after the expiry date (EXP) printed on the pack has passed, or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it 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 any allergies to foods, dyes, preservatives or any other medicines.

Tell your doctor if you are using any other medicines, including medicines you buy without a prescription.

Tell your doctor if you are breastfeeding, pregnant or trying to become pregnant. Your doctor will discuss the risks and benefits with you.

BACTROBAN nasal ointment should not be used to treat infections in or near the eyes.

Medicines like BACTROBAN nasal ointment can cause inflammation of the colon (large intestine), causing diarrhoea, usually with blood and mucus, stomach pain, fever (pseudomembranous colitis). Tell your doctor as soon as possible if you get any of these symptoms.

Taking other medicines

Do not mix BACTROBAN nasal ointment with any other preparation. They may prevent BACTROBAN nasal ointment from working.

How to use BACTROBAN nasal ointment

Follow your doctor's instructions about how and when to use BACTROBAN nasal ointment. Please read the direction label carefully.

If you have any questions about BACTROBAN nasal ointment and how to use it, please ask your doctor or pharmacist.

How much to use:

Use BACTROBAN nasal ointment as directed by your doctor or pharmacist.

BACTROBAN nasal ointment is usually applied two or three times a day. Your doctor or pharmacist will tell you how many times to apply the ointment.

How to use it:

Always wash your hands before and after applying BACTROBAN nasal ointment. Squeeze a small amount (about the size of a matchstick head) onto the tip of your little finger and apply to the inside surface at the front of each nostril. Gently press your nostrils together to help spread the ointment throughout your nose. A swab, such as a cotton bud may be used for application to infants or patients who are very ill.

How long to use it for:

Use BACTROBAN nasal ointment for as long as your doctor or pharmacist tells you to. BACTROBAN nasal ointment is usually applied for between 5 and 7 days. Do not use for more than 10 days.

Do not stop using BACTROBAN nasal ointment, or change the dose without first checking with your doctor.

If you miss a dose:

If you forget an application, apply some BACTROBAN nasal ointment as soon as you can, then continue as before.

If you take too much (overdose):

Immediately telephone your doctor or Poisons Information Centre (In Australia call 13 11 26) for advice, if you think you or anyone else may have used too much BACTROBAN nasal ointment or swallowed accidently, even if there are no signs of discomfort or poisoning.

If you are not sure what to do, contact your doctor, pharmacist or nearest hospital.

While you are using BACTROBAN nasal ointment

Things you must do:

Tell your doctor if, for any reason, you have not used your medicine exactly as directed. Otherwise, your doctor may think that it was not working as it should and change your treatment unnecessarily.

Stop using BACTROBAN nasal ointment and tell your doctor if you develop an allergic reaction (such as a rash, local pain or swelling).

Keep the ointment away from your eyes. If BACTROBAN nasal ointment is accidentally applied to the eyes, wash the eyes thoroughly with water.

Things you must not do:

Do not give this medicine to anyone else, even if their symptoms seem similar to yours.

Do not use BACTROBAN nasal ointment to treat any other complaints unless your doctor says to. Do not mix BACTROBAN nasal ointment with any other preparation. They may prevent BACTROBAN nasal ointment from working.

It is important that you take the full course of BACTROBAN nasal ointment. Don't stop early as the amount of bacteria in your nose may not be reduced.

Side effects

Check with your doctor as soon as possible if you think you are experiencing any side effects or allergic reactions due to using BACTROBAN nasal ointment, even if the problem is not listed below. Like other medicines, BACTROBAN nasal ointment can cause some side effects. If they occur, they are most likely to be minor and temporary. However, some may be serious and need medical attention.

The most commonly reported side effects are:

• Irritation
• Itching
• Tingling
• Burning
• Stinging
• Soreness
• Post nasal drip
• Sinus pain
• Runny or blocked nose
• Facial pain
• Conjunctivitis

Allergic reactions such as a rash, hives or swelling can occur with the use of BACTROBAN nasal ointment.

Tell your doctor immediately if you notice any of the following:

• Wheezing, swelling of the lips/mouth, difficulty in breathing, hayfever, lumpy rash (hives) or fainting. These could be symptoms of an allergic reaction.

This is not a complete list of all possible side effects. Others may occur in some people and there may be some side effects not yet known.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

After using BACTROBAN nasal ointment

Storage:

Keep this medicine where children cannot reach it, such as in a locked cupboard. You should keep BACTROBAN nasal ointment in the original pack below 25°C.

Do not leave in a car, on a window sill or in the bathroom.

Return any unused or expired medicine to your pharmacist.

Product description

What BACTROBAN nasal ointment looks like:

BACTROBAN nasal ointment is a white ointment supplied in 3 g tubes.

Ingredients:

BACTROBAN nasal ointment contains the active ingredient mupirocin.

BACTROBAN nasal ointment also contains the following inactive ingredients: white soft paraffin and Softisan 649 (a mixture of natural vegetable fatty acids).

Sponsor:

GlaxoSmithKline Australia Pty Ltd
Level 4
436 Johnston Street
Abbotsford Victoria 3067

Where to go for further information:

Pharmaceutical companies are not in a position to give people an individual diagnosis or medical advice. Your doctor or pharmacist is the best person to give you advice on the treatment of your condition.

This leaflet was prepared on 15 October 2013.

The information provided applies only to BACTROBAN® nasal ointment.

BACTROBAN® is a registered trade mark of the GlaxoSmithKline group of companies.

BACTROBAN nasal ointment: AUST R 11199

©2010 GlaxoSmithKline

Version 4.0

Published by MIMS January 2014

1 Name of Medicine

Mupirocin calcium.

2 Qualitative and Quantitative Composition

Bactroban nasal ointment contains mupirocin calcium 2% w/w as the active ingredient.
Each gram of Bactroban nasal ointment 2% contains 20 mg mupirocin as the calcium salt.

List of excipients with known effect.

3 Pharmaceutical Form

Nasal ointment.

4 Clinical Particulars

4.1 Therapeutic Indications

Bactroban (mupirocin) nasal ointment is indicated for the elimination of nasal carriage of Staphylococci including methicillin resistant Staphylococcus aureus (MRSA).

4.2 Dose and Method of Administration

Adults and children.

4.3 Contraindications

Bactroban nasal ointment is contraindicated in patients who have demonstrated hypersensitivity to mupirocin calcium or any components of the formulation.

4.4 Special Warnings and Precautions for Use

If a reaction suggesting sensitivity or chemical irritation should occur with the use of Bactroban nasal ointment, treatment should be discontinued, the product should be wiped off and appropriate alternative therapy for the infection instituted.
Bactroban nasal ointment formulation is not suitable for ophthalmic use.
Avoid contact with the eyes. If contaminated, the eyes should be thoroughly irrigated with water until the ointment residues have been removed.
As with other antibacterial products, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. Appropriate measures should be taken if this occurs.
The occurrence of resistance to topical mupirocin has occasionally been reported. The possibility of the development of resistance following intranasal use should therefore be borne in mind, particularly in treatment courses lasting longer than 5-7 days. Long-term, continuous use of Bactroban nasal ointment should be avoided to minimise this possibility, particularly in the hospital environment.
Pseudomembranous colitis has been reported with the use of antibiotics and may range in severity from mild to life threatening. Therefore, it is important to consider its diagnosis in patients who develop diarrhoea during or after antibiotic use. Although this is less likely to occur with topically applied mupirocin, if prolonged or significant diarrhoea occurs or the patient experiences abdominal cramps, treatment should be discontinued immediately and the patient investigated further.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Bactroban nasal ointment should not be mixed with other preparations as there is a risk of dilution, resulting in a reduction in the antibacterial activity and potential loss of stability of the mupirocin in the ointment.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

The following local adverse reactions with an overall incidence of approximately 2%, have been reported in connection with the use of this product: irritation, itching, tingling, burning, stinging, soreness, facial pain over maxillae, postnasal drip, sinusitis, rhinitis and conjunctivitis. However, less than 0.2% of patients withdrew due to adverse experiences.
Systemic allergic reactions including anaphylaxis, generalised rash, urticaria and angioedema have been reported very rarely.

Reporting suspected adverse effects.

4.9 Overdose

There is currently limited experience with overdosage of Bactroban.
There is no specific treatment for an overdose of Bactroban. In the event of overdose, the patient should be treated supportively with appropriate monitoring as necessary.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

This formulation has been designed as appropriate for use in the interior nares. Limited data are available on the absorption of mupirocin following intranasal application in adults. Adverse effects from continued absorption from the nose cannot be ruled out.
Mupirocin is absorbed in neonates and premature infants following intranasal administration of mupirocin ointment. In clinical studies of neonates, intranasal administration of mupirocin for up to 5 days was well tolerated. The safety of courses lasting longer than 5 days in neonates and infants has not been studied.
If absorption occurs, mupirocin will be quickly hydrolysed to the antimicrobially inactive metabolite monic acid, which is rapidly cleared from the body.
No evidence of contact sensitisation has been demonstrated with the white soft paraffin ointment formulation of mupirocin (Bactroban nasal ointment).
Whilst mupirocin successfully eradicates S. aureus colonisation of the nasal mucosa there are currently insufficient data to determine the frequency of, and time to, recolonisation.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Bis-disglyceryl polyacyladipate-2.
White soft paraffin.

6.2 Incompatibilities

See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C.

6.5 Nature and Contents of Container

Bactroban (mupirocin) nasal ointment 2% is supplied in 3 g tubes.

6.6 Special Precautions for Disposal

Any product remaining at the end of treatment should be discarded.
In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Mupirocin is a naturally occurring antibiotic, produced by fermentation of the organism Pseudomonas fluorescens.
The chemical name is 9-4-{5S-(2S,3S-epoxy-5S-hydroxy- 4S-methylhexyl)- 3R,4R-dihydroxytetrahydropyran-2S-y1}- 3-methylbut-2-(E)-enoyloxy-nonanoic acid.

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes