Label: Information for the Patient

Bactroban 20 mg/g Ointment

mupirocin

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

• Keep this label, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who may 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 ointment contains mupirocin, an antibiotic, which acts by eliminating the bacteria that cause infections.

It is used to treat superficial skin infections as long as their extent is limited.

Do not use Bactroban ointment:

• If you are allergic to mupirocin or to any of the other ingredients of this medicine (listed in section 6)
• Do not use by intranasal or ophthalmic route
• 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 causeskin irritationandallergic reactions.See section 4.

• Keep the ointment away from the eyes. If the ointment accidentally comes into contact with the eyes,rinse them abundantly 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 renal function.

Use of Bactroban ointment with other medicines

Inform your doctor or pharmacist if you are using, have used recently or may have to use any other medicine. This includes medicines obtained without a prescription.

Do not use this medicine simultaneously with other products intended for the treatment of the same area of application.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medicine.

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

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

The passage of mupirocin to breast milk is unknown. If you are breastfeeding, you must consult with your doctor before using this medicine.

If this medicine is eventually used to treat cracks in the nipple, the breast should be thoroughly washed to remove any remaining product before breastfeeding.

Driving and operating machinery

This medicine does not affect the ability to drive or operate machinery.

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

Skin use. Exclusively for external use.

Adults and children

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

Patients with renal insufficiency

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

Older patients

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

Method of use:

• Before applicationwash your handsand the area to be treated.
• With the help of a cotton ball or swab, applya small amountof ointment to the entire affected area.
• After applying the ointment, you may 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 improvement, consult your doctor.

If you use more Bactrobanointmentthan youshould

If you haveappliedmore ointment than you should,carefully remove the excess.

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

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.

If you forgot to use Bactrobanointment

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 compensate for the missed doses.

Do not discontinue treatment before the indicated time by your doctor, even if you feel better. If you do, the infection may reappear.

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

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

Situations you need to watch for:

Severe allergic reactions

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

• skin rash that causes itching
• swelling, 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 Bactroban ointment.

Bactroban ointment can causeskin irritation.

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

In rare cases, medicines like Bactroban ointment (containing an antibiotic), can cause inflammation of the colon (large intestine), causing diarrhea, usually with blood and mucus, stomach pain, fever (colitis pseudomembranosa).

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

Side effectsfrequent

May affect up to1 in 10 people:

• burning sensation at the application site.

Side effectsoccasional

May affect up to1 in 100 people:

• itching, redness, stinging, and/or dryness localized at the application site.

Side effectsvery rare

May affect up to1 in 10,000 people:

• allergic reactions.

Reporting side effects

If you experienceanytype ofside effect, consultyour doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly to theSpanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Store below 25 °C.

Do not use this medication after the expiration date that appears on the packaging and tube. The expiration date is the last day of the month indicated.

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

Do not use this medication if you observe that the ointment does not have a white or almost white color.

Dispose of any remaining product.

Medications should not be thrown away through drains or in the trash. Deposit the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need.This will help protect the environment.

Composition of Bactroban ointment

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

Appearance of the product and contents of the packaging

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

Holder of the marketing authorization

GlaxoSmithKline, S.A.

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

28760 Tres Cantos

Madrid

Tel. 900 20 27 00

[email protected]

Responsible for manufacturing

GlaxoSmithKline Trading Services Limited
12 Riverwalk
Citywest Business Campus
Dublin 24
Ireland

or

Delpharm Poznan Spólka Akcyjna

ul. Grunwaldzka 189

60-322 Poznan

Poland

Last review date of this leaflet:March 2020.

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