Consumer medicine information

Medicianz Mupirocin 2% Ointment

Mupirocin

BRAND INFORMATION

Brand name

Medicianz Mupirocin Ointment

Active ingredient

Mupirocin

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Medicianz Mupirocin 2% Ointment.

What is in this leaflet


Please read this leaflet carefully before you use Medicianz Medicianz MUPIROCIN Ointment.
This leaflet answers some common questions about Medicianz MUPIROCIN 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 Medicianz MUPIROCIN Ointment against the benefits they expect it will have for you.
If you are helping someone else to use Medicianz MUPIROCIN Ointment, read this leaflet before applying the first application.
If you have any concerns about being treated with Medicianz MUPIROCIN 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 Medicianz MUPIROCIN Ointment is used for


Medicianz MUPIROCIN 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.
Medicianz MUPIROCIN Ointment is used for the treatment of mild impetigo (school sores).
Medicianz MUPIROCIN Ointment is for use on your skin only.
Ask your doctor if you have any questions about why this medicine has been prescribed for you.
Your doctor may have prescribed Medicianz MUPIROCIN Ointment for another reason.
Medicianz MUPIROCIN Ointment is not addictive.

Before you use Medicianz MUPIROCIN Ointment

When you should not be given it


You must not be given Medicianz MUPIROCIN 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 Medicianz MUPIROCIN Ointment after the expiry date printed on the pack, or 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.
If you are using Medicianz MUPIROCIN Ointment on a cracked nipple, wash the nipple well before breast feeding your baby.
Medicianz MUPIROCIN Ointment should not be used to treat infections in or near the eyes, nostrils or mouth.
If Medicianz MUPIROCIN Ointment is accidentally applied to the eyes, wash the eyes thoroughly with water.
Medicianz MUPIROCIN Ointment contains polyethylene glycol. Do not use Medicianz MUPIROCIN Ointment on large areas of broken or damaged skin, especially if you suffer from reduced kidney function.
Medicianz MUPIROCIN Ointment should not be used to treat areas of skin near tubes inserted into your body for the delivery or removal of fluid (cannulae). Medicianz MUPIROCIN Ointment should not be used in combination with cannulae.
If you develop an allergic reaction (such as a rash, local pain or swelling), wipe off the ointment, stop using Medicianz MUPIROCIN Ointment and tell your doctor.
Medicines like Medicianz MUPIROCIN 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 Medicianz MUPIROCIN 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 Medicianz MUPIROCIN Ointment with any other preparation. They may prevent Medicianz MUPIROCIN Ointment from working.

Taking Medicianz MUPIROCIN 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 to be applied to the affected area three times a daily.
If you have any questions about Medicianz MUPIROCIN 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 Medicianz MUPIROCIN Ointment.
With a piece of clean cotton wool or a gauze swab, apply a small quantity of Medicianz MUPIROCIN Ointment to cover the affected area.
After applying the ointment, you may cover the treated area with a sterile bandage or gauze dressing, unless your doctor has told you to leave it uncovered.

How long to use it


Use Medicianz MUPIROCIN Ointment for as long as your doctor or pharmacist tells you to. Medicianz MUPIROCIN Ointment is usually applied for up to 10 days.
It is important that you take the full course of Medicianz MUPIROCIN 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 Medicianz MUPIROCIN Ointment as soon as you can, then continue as before.

Use in children


The use of Medicianz MUPIROCIN Ointment in children under 4 weeks of age is not recommended.

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 Medicianz MUPIROCIN 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 Medicianz MUPIROCIN 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 Medicianz MUPIROCIN 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 Medicianz MUPIROCIN Ointment to treat any other complaints unless your doctor says to.
Do not stop using Medicianz MUPIROCIN Ointment, or change the dose without first checking with your doctor.

Side effects


Tell your doctor or nurse as soon as possible if you do not feel well while you are being given Medicianz MUPIROCIN Ointment.
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 Medicianz MUPIROCIN 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:

  • Itching
  • Dryness
  • Burning
  • Redness
  • Stinging
  • Pain
  • Swelling

Allergic reactions such as a rash, hives or swelling can occur with the use of Medicianz MUPIROCIN Ointment.
If you get a skin reaction, stop using MUPIROCIN cream. Wipe off any cream and tell your doctor as soon as possible.
Tell your doctor if you notice any of the following:
  • Swelling, itching, burning or pain in the area where Medicianz MUPIROCIN Ointment is applied.
  • 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 Medicianz MUPIROCIN Ointment


You should keep Medicianz MUPIROCIN Ointment in the original pack below 25°C. After first opening of the tube, the contents can be used for up to 10 days.
Do not store Medicianz MUPIROCIN 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:


Medicianz MUPIROCIN Ointment is a white ointment supplied in 15g tubes.

Ingredients


Medicianz MUPIROCIN Ointment contains the active ingredient Mupirocin.
Medicianz MUPIROCIN Ointment also contains polyethylene glycol (Macrogol 400 and Macrogol 3350).

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 Numbers
AUST R 279471
This leaflet was prepared in July 2017

BRAND INFORMATION

Brand name

Medicianz Mupirocin Ointment

Active ingredient

Mupirocin

Schedule

S4

 

Notes

Distributed by Medsurge Healthcare Pty Ltd

1 Name of Medicine

Mupirocin.

2 Qualitative and Quantitative Composition

Medicianz Mupirocin Ointment contains mupirocin 2% w/w equivalent to 20 mg/g mupirocin as the active ingredient.
Mupirocin is a naturally occurring antibiotic, produced by fermentation of the organism Pseudomonas fluorescens.
Each gram of Medicianz Mupirocin Ointment contains 20 milligram of mupirocin. Medicianz Mupirocin Ointment also contains polyethylene glycol (macrogol) 400 and polyethylene glycol (macrogol) 3350.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Ointment.
Medicianz Mupirocin Ointment is a white, translucent, water-soluble, polyethylene glycol based, homogeneous off-white ointment, which is odourless or nearly odourless.

4 Clinical Particulars

4.9 Overdose

The toxicity of mupirocin is very low. In the event of accidental ingestion of the ointment symptomatic treatment should be given.
In case of erroneous oral intake of large quantities of the ointment, renal function should be closely monitored in patients with renal insufficiency because of the possible side effects of polyethylene glycol.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Results of the following studies performed with mupirocin calcium or mupirocin sodium in vitro and in vivo did not indicate a potential for mutagenicity: rat primary hepatocyte unscheduled DNA synthesis, sediment analysis for DNA strand breaks, metaphase analysis of human lymphocytes, mouse lymphoma assay and bone marrow micronuclei assay in mice.
Carcinogenicity. The carcinogenic potential of mupirocin has not been assessed in long-term animal studies.

6 Pharmaceutical Particulars

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. The chemical structure of mupirocin is shown below:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSMUPIRO.gif Molecular formula: C26H44O9.
Molecular mass: 500.63.
CAS number. 12650-69-0.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/MEDMUPST.gif