Altargo

ALTARGO^®

retapamulin

Consumer Medicine Information

This leaflet answers some common questions about Altargo. 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 Altargo against the benefits they expect it will 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.

Altargo ointment contains the antibiotic retapamulin as the active ingredient. It also contains the inactive ingredient soft white paraffin and may contain traces of the antioxidant, butylated hydroxytoluene.

The active ingredient is derived from the antibiotic pleuromutilin. It works by inhibiting bacterial protein synthesis.

Altargo is used to treat the following skin infections caused by bacteria in adults and children aged nine months and older:

primary impetigo

secondarily infected traumatic lesions e.g. small lacerations, abrasions, sutured wounds

secondarily infected dermatoses including infected psoriasis, infected atopic dermatitis and infected contact dermatitis

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

Your doctor may have prescribed it for another reason.

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.

There is not enough information to recommend the use of this medicine for children under the age of nine months.

Do not use Altargo if you have an allergy to:

any medicine containingretapamulin

soft white paraffin

butylated hydroxytoluene

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 on a child under the age of nine months.

Safety and effectiveness in children younger than nine months has not been established.

Do not use this medicine after the expiry date printed on the pack 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.

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor:

if an allergic reaction or severe irritation occurs.Stop using Altargo, carefully wipe off the ointment and contact your doctor.

if you notice any worsening of the infection or develop increased redness, irritation or other signs and symptoms at the site of application.

Altargo is for external use only.Do not ingest.Do not use in the eyes, on the mouth or lips, inside the nose, inside the female genital area, or inside the anal area.

Altargo is not suitable for treating abscesses.

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

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

Altargo should only be used in pregnancy or during breast-feeding when the potential benefits outweigh the potential risks associated with treatment.

Tell your doctor if the patient is a child less than two years old who is being treated with any other medicines, including ketoconazole. Your doctor may decide that the other medicine should not be used at the same time as Altargo.

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

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

Some medicines and Altargo may interfere with each other. These include:

ointments, creams or lotionsapplied to the same area of skin being treated with Altargo

If the patient is a child less than two years old it is especially important that you tell your doctor about any other medicines that the child is being given, including medicines bought without a prescription. It is possible that using Altargo in children who are taking certain medicines (such as some medicines used to treat fungal infections) could result in blood concentrations of Altargo that are higher than usual. This might lead to side effects. Your doctor will decide if Altargo can be used for a child aged less than two years old who is taking other medicines.

These medicines may be affected by Altargo or may affect how well it works. You may need different amounts of your medicines, or you may need to use different medicines.

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

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 box, ask your doctor or pharmacist for help.

Apply a thin layer of ointment to the infected skin.

Apply a thin layer of ointment to the infected skin twice a day for five days.

After applying your ointment, you may cover the treated area with a sterile bandage or gauze dressing, unless your doctor/healthcare provider has told you to leave it uncovered.

Wash your hands before and after applying the ointment.

This medication is for use on the skin only.Do not use in the eyes, on the mouth or lips, inside the nose or inside the female genital area.If the ointment accidentally gets on to these areas, wash the area with water and consult your doctor if you experience discomfort.If you accidentally use Altargo inside your nose you could have a nose bleed.

Use your medicine at about the same times each day.

Using Altargo twice a day at the same times each day will have the best effect. It will also help you remember when to use it.

It does not matter if you use this medicine before or after food.

Continue using your medicine for as long as your doctor advises.

If your condition does not improve after 3 to 4 days of treatment, consult your doctor.

If you miss an application of Altargo, apply the ointment as soon as you remember, and apply the next dose at the usual time.

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

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

Problems with overdosage with this medicine are unlikely.

If you use too much Altargo, carefully wipe off the extra ointment.

If you accidentally swallow Altargo, contact your doctor.

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are using Altargo.

Tell any other doctors, dentists, and pharmacists who treat you that you are using this medicine.

If you are going to have surgery, tell the surgeon or anaesthetist that you are using this medicine.

It may affect other medicines used during surgery.

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

Keep all of your doctor’s appointments so that your progress can be checked.

Do not use Altargo to treat any other complaints unless your doctor tells you to.

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

Do not stop using your medicine or lower the dosage without checking with your doctor.

If you notice any worsening of the infection or develop increased redness, irritation or other signs and symptoms at the site of application you should stop using Altargo and tell your doctor.

If there is no improvement in your infection after 3 to 4 days of treatment, consult your doctor.

Tell your doctor or pharmacist as soon as possible if you do not feel well whilst using Altargo.

Most patients do not have any problems with Altargo. However, 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.

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

Ask your doctor or pharmacist to answer any questions you may have.

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

itching, swelling, pain or a burning sensation where you have used Altargo

If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:

severe itching

severe rash

swelling of the face, lips or tongue

The above list includes very serious side effects. You may need urgent medical attention or hospitalisation.

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

Keep your ointment in its original pack.

If you take the ointment out of the tube it may not keep well.

Keep your ointment where the temperature stays below 25°C.

Do not store Altargo 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.

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

Your ointment will have an expiry date on the pack. Do not use after this date.

Altargo is an off-white, smooth ointment supplied in 5 g and 15 g aluminium tubes.

Altargo contains 10 mg of retapamulin per gram (1% w/w) as the active ingredient. It also contains the inactive ingredient soft white paraffin and may contain traces of the antioxidant, butylated hydroxytoluene.

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

GlaxoSmithKline Australia Pty Ltd

Level 4, 436 Johnston Street

Abbotsford, Victoria, 3067.

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

© 2012 GlaxoSmithKline

This leaflet was prepared on 14 August 2013

Altargo AUST R: 198947

Version 2.0