BACTROBAN 20 mg/g ointment

Introduction

Patient Information Leaflet

Bactroban 20 mg/g ointment

mupirocin

Read this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What Bactroban ointment is and what it is used for
2. What you need to know before you use Bactroban ointment
3. How to use Bactroban ointment
4. Possible side effects
5. Storing Bactroban ointment
6. Contents of the pack and other information

1. What Bactroban ointment is and what it is used for

Bactroban ointment contains mupirocin, an antibiotic, which works by killing the bacteria that cause infections.

Antibiotics are used to treat bacterial infections and will not work for viral infections such as the common cold or flu.

It is important that you follow the instructions regarding the dose, administration interval, and duration of treatment indicated by your doctor.

Do not store or reuse this medicine. If you have any leftover antibiotic after finishing the treatment, return it to the pharmacy for proper disposal. Do not throw away medicines via wastewater or household waste.

It is used to treat superficial skin infections, provided the affected area is limited.

2. What you need to know before you use Bactroban ointment

Do not use Bactroban ointment:

• If you are allergic to mupirocin or any of the other ingredients of this medicine (listed in section 6)
• Do not use intranasally or ophthalmically
• Do not use with cannulas or near intravenous catheters

Warnings and precautions

Consult your doctor or pharmacist before starting to use Bactroban ointment.

Bactroban ointment may cause skin irritationand allergic reactions. See section 4.

• Keep the ointment away from the eyes. If the ointment accidentally comes into contact with the eyes, wash them thoroughly with water.

Bactroban ointment contains a component (excipient) called polyethylene glycol, which when applied to damaged skin may be absorbed by the body, especially in the case of extensive lesions or open wounds, worsening kidney function.

Using Bactroban ointment with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines. This includes medicines obtained without a prescription.

Do not use this medicine at the same time as other products intended for the treatment of the same application area.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Information on the safety of this medicine in pregnant women is limited.

Bactroban ointment should not be used in pregnant women unless the benefits outweigh the potential risks of treatment.

It is not known whether mupirocin can pass into breast milk. If you are breastfeeding, consult your doctor before using this medicine.

If this medicine is used to treat cracks in the nipple, wash your breast well to remove any remaining product before breastfeeding.

Driving and using machines

This medicine does not affect the ability to drive or use machines.

3. How to use Bactroban ointment

Follow exactly the administration instructions of this medicine indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

For cutaneous use. For external use only.

Adults and children

Apply the ointment 2-3 times a day, up to a maximum of 10 days. Your doctor will assess the treatment after 5 days to evaluate its progress.

Patients with renal insufficiency

Your doctor will assess the use of this medicine in case of risk of polyethylene glycol absorption when applied to damaged skin.

Elderly patients

No dose adjustment is necessary unless there is evidence of moderate or severe renal insufficiency.

Method of administration:

• Before application, wash your handsand the area to be treated.
• Using a cotton swab or gauze, apply a small amountof ointment to the entire affected area.
• After applying the ointment, you can cover the treated area with a bandage or gauze, unless your doctor tells you to leave the area uncovered.

If after five days of treatment you do not notice any improvement, consult your doctor.

If you use more Bactroban ointment than you should

If you have applied more ointment than you should, carefully remove the excess.

If you accidentally ingest this medicine, consult your doctor or pharmacist.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use Bactroban ointment

If you forget to administer a dose, apply the next one as soon as possible and continue the administration as before.

Do not administer a double dose to make up for forgotten doses.

Do not stop the treatment before your doctor indicates, even if you feel better. If you do, the infection may recur.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Situations that you need to monitor:

Severe allergic reactions

These reactions are very rare in people using Bactroban ointment. The signs include:

• itchy skin rash
• swelling, sometimes of the face or mouth, causing difficulty breathing
• collapse or loss of consciousness.

• If you have any of these symptoms, contact your doctor immediately. Stop using Bactroban ointment.

Bactroban ointment may cause skin irritation.

• If you have skin irritation, stop using Bactroban ointment. Remove any remaining medicine and consult your doctor as soon as possible.

Rarely, medicines like Bactroban ointment (which contain an antibiotic) can cause inflammation of the colon (large intestine), causing diarrhea, usually with blood and mucus, stomach pain, fever (pseudomembranous colitis).

• If you have any of these symptoms, consult your doctor as soon as possible.

Common side effects

May affect up to 1 in 10 people:

• burning sensation at the application site.

Uncommon side effects

May affect up to 1 in 100 people:

• itching, redness, stinging, and/or dryness localized to the application area.

Rare side effects

May affect up to 1 in 10,000 people:

• allergic reactions.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Bactroban ointment

Keep this medicine out of the sight and reach of children.

Store below 25°C.

Do not use this medicine after the expiry date stated on the packaging and tube. The expiry date is the last day of the month stated.

Once opened, the validity period of this medicine is 10 days.

Do not use this medicine if you notice that the ointment is not white or almost white in color.

Dispose of any unused product.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Bactroban ointment

• The active ingredient is mupirocin. Each gram of ointment contains 20 mg of mupirocin.
• The other ingredients are polyethylene glycol 400 and polyethylene glycol 3350.

Appearance of the product and pack contents

Bactroban is presented in an aluminum tube with a nozzle and cap, containing 15 or 30 grams of ointment.

Marketing authorization holder

GlaxoSmithKline, S.A.

P.T.M.C/Severo Ochoa, 2

28760 Tres Cantos

Madrid

Phone: 900 20 27 00

[email protected]

Manufacturer

GlaxoSmithKline Trading Services Limited12 RiverwalkCitywest Business CampusDublín 24Irlanda

or

Delpharm Poznan Spólka Akcyjna

ul. Grunwaldzka 189

60-322 Poznan

Poland

Date of last revision of this leaflet:March 2020.

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es