Consumer medicine information

What is in this leaflet

Please read this leaflet carefully before you use Medsurge MUPIROCIN Nasal Ointment.

This leaflet answers some common questions about Medsurge MUPIROCIN Nasal 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 benefits and risks. Your doctor has weighed the risks of you using the Medsurge MUPIROCIN Nasal Ointment against the benefits they expect it will have for you.

If you are helping someone else to use Medsurge MUPIROCIN Nasal Ointment, read this leaflet before applying the first application.

If you have any concerns about being treated with Medsurge MUPIROCIN Nasal Ointment, ask your doctor or pharmacist.

This leaflet was last updated on the date at the end of this leaflet. More recent information may be available. The latest Consumer Medicine Information is available from your pharmacist, doctor, or from www.tga.gov.au and may contain important information about the medicine and its use of which you should be aware.

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

What Medsurge MUPIROCIN Nasal Ointment is used for

Medsurge MUPIROCIN Nasal Ointment contains mupirocin calcium 20 mg/g (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.

Medsurge MUPIROCIN Nasal Ointment is used to remove bacteria, including the bacteria called “Staphylococcus aureus (golden staph.)” from inside your nose. Medsurge MUPIROCIN Nasal Ointment is for use in your nose only.

Ask your doctor if you have any questions about why this medicine has been prescribed for you.

Your doctor may have prescribed Medsurge MUPIROCIN Nasal Ointment for another reason.

Medsurge MUPIROCIN Nasal Ointment is not addictive.

Before you use Medsurge MUPIROCIN Nasal Ointment

When you should not be given it:

You must not be given Medsurge MUPIROCIN Nasal Ointment if you have an allergy to:

• any medicine containing mupirocin calcium.
• 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 Medsurge MUPIROCIN Nasal Ointment after the expiry date printed on the pack, or if the ointment shows visible signs of deterioration, 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 allergies to any other medicines, foods, preservatives or dyes.

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

Medsurge MUPIROCIN Nasal Ointment should not be used to treat infections in or near the eyes. If Medsurge MUPIROCIN Nasal Ointment is accidentally applied to the eyes, wash the eyes thoroughly with water.

If you develop an allergic reaction (such as a rash, local pain or swelling), wipe off the ointment, stop using Medsurge MUPIROCIN Nasal Ointment and tell your doctor.

Medicines like Medsurge MUPIROCIN 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.

If you have not told your doctor about any of the above, tell him/ her before you start using Medsurge MUPIROCIN Nasal Ointment.

Taking other medicines:

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

Do not mix Medsurge MUPIROCIN Nasal Ointment with any other preparation. They may prevent Medsurge MUPIROCIN Nasal Ointment from working.

Taking Medsurge MUPIROCIN Nasal Ointment

How much to use:

Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.

The usual recommendation is for a small amount, about the size of a match head, is to be applied inside the nose two to three times a day.

If you have any questions about Medsurge MUPIROCIN Nasal Ointment and how to use it, please ask your doctor or pharmacist for help.

How to use it;

Always wash your hands before and after applying Medsurge MUPIROCIN Nasal Ointment.

Squeeze a small quantity of Medsurge MUPIROCIN Nasal Ointment (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 Medsurge MUPIROCIN Nasal Ointment:

Use Medsurge MUPIROCIN Nasal Ointment for as long as your doctor or pharmacist tells you to. Medsurge MUPIROCIN Nasal Ointment is usually applied for up to 7 days. Do not use for more than 10 days.

It is important that you take the full course of Medsurge MUPIROCIN Nasal Ointment. Do not stop early as your symptoms may disappear before the infection is fully cleared.

If you forget to use it:

If you forget an application, apply some Medsurge MUPIROCIN 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 (telephone 131126) for advice, if you think you or anyone else may have swallowed a large quantity of Medsurge MUPIROCIN Nasal Ointment, even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

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

While you are taking Medsurge MUPIROCIN Nasal Ointment

Things you must do:

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking Medsurge MUPIROCIN Nasal Ointment.

Tell any other doctors, dentists, and pharmacists who treat you that you have been given this medicine.

If you become pregnant while using this medicine, tell your doctor immediately.

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.

Things you must not do:

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

Do not use Medsurge MUPIROCIN Nasal Ointment to treat any other complaints unless your doctor says to.

Do not mix Medsurge MUPIROCIN Nasal Ointment with any other preparation. They may prevent Medsurge MUPIROCIN Nasal Ointment from working.

It is important that you take the full course of Medsurge MUPIROCIN Nasal Ointment. Don't stop early as the amount of bacteria in your nose may not be reduced.

Do not stop using Medsurge MUPIROCIN Nasal Ointment or change the dose without first checking with your doctor.

Side effects

This medicine helps most people, but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

Check with your doctor as soon as possible if you think you are experiencing any side effects or allergic reactions due to taking Medsurge MUPIROCIN Nasal Ointment, even if the problem is not listed below.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

The most commonly reported side effects are:

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

Allergic reactions such as a rash, hives or swelling can occur with the use of Medsurge MUPIROCIN 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.

Tell your doctor or pharmacist if you notice any side effects from your medicine which are not mentioned here.

After being given Medsurge MUPIROCIN Nasal Ointment

You should keep Medsurge MUPIROCIN Nasal Ointment in the original pack below 25°C. After first opening of the tube, the contents can be used for up to 7 days.

Do not store Medsurge MUPIROCIN Nasal Ointment 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 it 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.

Return any unused or expired medicine to your pharmacist.

Product description

What it looks like:

Medsurge MUPIROCIN Nasal Ointment is an off-white smooth ointment supplied in 3g and 5g tubes. Not all pack sizes may be marketed.

Ingredients:

Medsurge MUPIROCIN Nasal Ointment contains the active ingredient Mupirocin as the calcium salt.

Medsurge MUPIROCIN Nasal Ointment also contains white soft paraffin and bis-diglyceryl polyacyladipate-2.

Sponsor

Medicianz Healthcare Pty Limited
Unit 2, 6-7 Gilda Court
Mulgrave Victoria
Australia 3170

Marketed and distributed by:

Medsurge Healthcare Pty Ltd

Australian Registration Number

AUST R 300228

This leaflet was prepared in April 2019.

Published by MIMS June 2019

Notes

Marketed and distributed by Medsurge Healthcare Pty Ltd.

1 Name of Medicine

Mupirocin Nasal Ointment contains mupirocin 2% w/w, as calcium salt, as the active ingredient.

2 Qualitative and Quantitative Composition

Mupirocin 20 mg/g (2% w/w), as mupirocin calcium.
Mupirocin is a naturally occurring antibiotic, produced by fermentation of the organism Pseudomonas fluorescens.
Each gram of Mupirocin Nasal Ointment contains 20 milligrams of mupirocin as the calcium salt in a white soft paraffin based ointment containing a glycerin ester (bis-diglyceryl polyacyladipate-2).
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Nasal Ointment.
Mupirocin Nasal Ointment is an off-white smooth nasal ointment.

4 Clinical Particulars

4.1 Therapeutic Indications

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

Mupirocin 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 Mupirocin Nasal Ointment, treatment should be discontinued, the product should be wiped off and appropriate alternative therapy for the infection instituted.
Mupirocin Nasal Ointment is not suitable for ophthalmic use.
Avoid contact with 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 Mupirocin 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

Mupirocin 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, post nasal 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.
No evidence of contact sensitization has been demonstrated with the white soft paraffin ointment formulation of mupirocin (Mupirocin Nasal Ointment).

Reporting suspected adverse effects.

4.9 Overdose

There is currently limited experience with overdosage of mupirocin.
There is no specific treatment for an overdose of mupirocin. 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.

Comparability of Mupirocin Nasal Ointment and Bactroban Nasal Ointment 2%.

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.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

White soft paraffin, Glycerin ester (bis-diglyceryl polyacyladipate-2).

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

3 years.
After first opening of the tube, the contents can be used for up to 7 days.

6.4 Special Precautions for Storage

Store below 25°C.

6.5 Nature and Contents of Container

Mupirocin Nasal Ointment is supplied in lacquered aluminium tubes fitted with a nozzle and screw cap in the following presentations (see Table 1).
Not all pack sizes may be distributed in Australia.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

The chemical name is: 9-[4-[5S-[2S,3S-epoxy-5S-hydroxy-4S-methylhexyl]-3R,4R-dihydroxytetrahydropyran-2S-yl]-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