Label: information for the user

Bactroban nasal 20 mg/g nasal ointment

mupirocin

Read this label carefully before starting to use this medication, as it contains important information for you.

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

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

This medication is used in the treatment of bacterial nasal infections.

Do not use Bactroban nasal:

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

Warnings and precautions

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

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

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

In rare cases, antibiotics can cause inflammation of the colon (large intestine), causing 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 discontinue treatment immediately.

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

Children and adolescents

The same dose as adults, see section 3.

Using Bactroban nasal with other medications

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

Pregnancy and breastfeeding

The information on the safety of mupirocin in pregnant women is limited. If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

The safety of mupirocin in breastfeeding women is unknown. If you are breastfeeding, you should consult your doctor before using this medication.

Driving and operating machinery

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

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Remember to use your medication. Your doctor will inform you of the duration of your treatment.

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

Administration form: nasal route.

Apply a small amount of Bactroban nasal in each nasal cavity two or three times a day.

Method of use:

Wash your handsbefore and after applying the ointment.

Using your little finger or with a cotton-tipped applicator(cotton swab or pledget)(apply a small amount of ointment, approximately the size of a match head (about 30 mg of ointment),on the inner surface of each nasal cavity.

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

Use2 - 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 cases of mupirocin overdose is limited.

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

Information for healthcare professionals:

There is no specific treatment for mupirocin overdose.

If you forgot to use Bactroban nasal

Do not administer a double dose to compensate for the missed doses.

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Situations to Monitor:

Severe Allergic Reactions

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

• raised rash that causes itching
• inflammation, sometimes of the face or mouth, which causes difficulty breathing
• collapse or loss of consciousness.

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

This medication may causeskin irritationandallergic reactions.

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

Less Common Adverse Effects

May affect up to 1 in 100 people:

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

Very Rare Adverse Effects

May affect up to 1 in 10,000 people:

• itching, redness, and stinging of the skin.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

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

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

Medications should not be disposed of through drains or in the trash. Deposit empty containers and unused medications at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of empty containers and unused medications. By doing so, you will help protect the environment.

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 components are: white soft paraffin and Softisan 649 (a mixture of glycerol esters).

Appearance of the product and contents of the packaging

This medicine is a nearly white ointment.

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

GlaxoSmithKline, S.A.P.T.M. C/ Severo Ochoa, 2

28760 Tres Cantos (Madrid)

Responsible for manufacturing:

GlaxoSmithKline Trading Services Limited
12 Riverwalk
Citywest Business Campus
Dublín 24
Irlanda

or

Delpharm Poznan Spólka Akcyjna

ul. Grunwaldzka 189

60-322 Poznan

Polonia

Last review date of this leaflet:January 2019.

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es