Package Insert: Information for the Patient

Plasimine 20 mg/g Ointment

mupirocin

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

• Keep this package insert 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 package insert. See section 4.

Plasimine contains mupirocin, an antibiotic, which acts by eliminating the bacteria that cause infections.

It is used to treat limited skin surface infections.

Do not use Plasimine:

• If you are allergic to mupirocin or to any of the other components of this medication (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 Plasimine.

Plasimine 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.

Plasimine 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 injuries or open wounds, worsening renal function.

Use of Plasimine with other medications

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

You should not use this medication simultaneously with other products intended for the treatment of the same application area.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

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

Plasimine 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 should consult with your doctor before using this medication.

If this medication is eventually used to treat nipple fissures, you should wash the breast well to remove any remaining product before breastfeeding.

Driving and operating machinery

This medication 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.

Topical 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 polyethylene glycol absorption when applied to damaged skin.

Older patients

No adjustment of dosage 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 Plasimine than you should

If you have applied more 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 forget to use Plasimine

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 could reappear.

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

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

Situations to Watch For:

Severe Allergic Reactions

These reactions occur very rarely in people using Plasimine. 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 experience any of these symptoms,contact your doctor immediately.Stop using Plasimine.

Plasimine may causeskin irritation.

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

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

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

Frequent Adverse Effects

May affect up to1 in 10 people:

• burning sensation at the application site.

Infrequent Adverse Effects

May affect up to1 in 100 people:

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

Rare Adverse Effects

May affect up to1 in 10,000 people:

• allergic reactions.

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.

Do not use this medication after the expiration date shown 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 unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused containers and medications. By doing so, you will help protect the environment.

Composition of Plasimine

• The active ingredient is mupirocin. Each gram of ointment contains 20 mg of mupirocin.
• The other components arepolyethylene glycol400 andpolyethylene glycol3350.

Appearance of the product and contents of the packaging

Plasimine is presented in an aluminum tube with a nozzle and a plastic cap, containing 15 or30 gramsof ointment.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization:

GlaxoSmithKline, S.A.

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

28760 Tres Cantos (Madrid)

Tel: +34 900 202 700

[email protected]

Responsible manufacturer:

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:March 2020.

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