BACTROBAN NASAL 20 mg/g NASAL OINTMENT

Introduction

Leaflet: information for the user

Bactroban nasal 20 mg/g nasal ointment

mupirocin

Read the entire leaflet carefully before starting to use this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Bactroban nasal is and what it is used for
2. What you need to know before starting to use Bactroban nasal
3. How to use Bactroban nasal
4. Possible side effects
5. Storage of Bactroban nasal
6. Package contents and additional information

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

Bactroban nasal is an antibiotic that contains mupirocin as the active ingredient.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as the flu or common cold.

It is essential that you follow the instructions regarding dosage, administration interval, and treatment duration indicated by your doctor.

Do not store or reuse this medicine. If you have any leftover antibiotic after completing the treatment, return it to the pharmacy for proper disposal. Do not throw medicines down the drain or in the trash.

This medicine is used to treat bacterial infections of the nose.

2. What you need to know before starting to use Bactroban nasal

Do not use Bactroban nasal:

• if you are allergic to mupirocin or any of the other components of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use this medicine.

Do not use this ointment if you have had an allergic reaction (a rash) to another ointment containing mupirocin.

If you develop an allergic reaction (such as a rash, local pain, or swelling) while using this medicine, stop treatment and consult your doctor as soon as possible.

In rare cases, antibiotics can cause inflammation of the colon (large intestine), leading to diarrhea, usually with blood and mucus, stomach pain, and fever (pseudomembranous colitis).

• If you experience any of these symptoms, consult your doctor as soon as possible and interrupt treatment immediately.

Do not use this ointment in the eyes. If the ointment accidentally enters the eyes, rinse with plenty of water to remove any remaining ointment.

Children and adolescents

Same dose as adults, see section 3.

Using Bactroban nasal with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine.

Pregnancy and breastfeeding

Information on the safety of mupirocin in pregnant women is limited. Therefore, if you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

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

Driving and using machines

No effects on the ability to drive and use machines have been observed.

3. How to use Bactroban nasal

Follow your doctor's instructions for administering this medicine exactly. If you are unsure, consult your doctor or pharmacist again.

Remember to use your medicine. Your doctor will indicate the duration of your treatment.

Adults (including elderly patients) and pediatric population (children and adolescents)

Form of administration: nasal.

Apply a small amount of Bactroban nasal to each nostril two or three times a day.

Mode of use:

Wash your handsbefore and after applying the ointment.

With your little finger or a cotton swab applicator(stick or cotton ball), apply a small amountof ointment, similar in size to a match head (approximately 30 mg of ointment), to the inner surface of each nostril.

With your index and thumb fingers, press both sides of the nose and gently massage to spread the ointment inside the nose.

Use 2-3 times a day for a period of 5 to 7 days.

If you use more Bactroban nasalthan you should

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

Currently, experience with mupirocin overdose cases is limited.

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.

Information for the healthcare professional:

There is no specific treatment for mupirocin overdose.

If you forget to use Bactroban nasal

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

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

4. Possible side effects

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

Situations that you need to monitor:

Severe allergic reactions

These reactions occur very rarely in people using Bactroban nasal. The signs include:

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

• If you experience any of these symptoms, contact your doctor immediately.Stop using this medicine.

This medicine may cause skin irritationand allergic reactions.

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

Uncommon side effects

May affect up to 1 in 100 people:

• runny nose
• itching, redness, burning sensation, tingling, and/or prickling in the nose.

Rare side effects

May affect up to 1 in 10,000 people:

• itching, redness, and prickling of the skin.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Bactroban nasal

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

Store below 25°C. Dispose of any leftover product.

Do not use this medicine after the expiration date stated on the packaging. The expiration date is the last day of the month indicated.

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

6. Package contents and additional information

Composition of Bactroban nasal

• The active ingredient is mupirocin (as mupirocin calcium). Each gram of ointment contains 20 mg of mupirocin (as mupirocin calcium).

• The other ingredients are: soft white paraffin and Softisan 649 (a mixture of glycerol esters).

Appearance of the product and package contents

This medicine is a nearly white ointment.

It is presented in an aluminum tube with a plastic nozzle and cap containing 3 g of ointment. It is packaged in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder:

GlaxoSmithKline, S.A.

C/ Severo Ochoa, 2

28760 Tres Cantos (Madrid)

Manufacturer:

GlaxoSmithKline Trading Services Limited

12 Riverwalk

Citywest Business Campus

Dublin 24

Ireland

or

Delpharm Poznan Spólka Akcyjna

ul. Grunwaldzka 189

60-322 Poznan

Poland

Date of the last revision of this leaflet:January 2019.

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