PLASIMINE 20 mg/g OINTMENT

Introduction

Package Leaflet: Information for the Patient

Plasimine 20 mg/g Ointment

mupirocin

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

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication 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 not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Plasimine and what is it used for
2. What you need to know before using Plasimine
3. How to use Plasimine
4. Possible side effects
5. Storage of Plasimine
6. Contents of the pack and further information

1. What is Plasimine and what is it used for

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

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

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

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

It is used to treat superficial skin infections, provided that their extent is limited.

2. What you need to know before using Plasimine

Do not use Plasimine:

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

Plasimine 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.

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

Using Plasimine with other medications

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

Do 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, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

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.

It is unknown whether mupirocin can pass into breast milk. If you are breastfeeding, consult your doctor before using this medication.

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

Driving and using machines

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

3. How to use Plasimine

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

Topical 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 evaluate the treatment after 5 days to assess its progress.

Patients with renal insufficiency

Your doctor will assess the use of this medication if there is a 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 it uncovered.

If you do not notice improvement after five days of treatment, 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 Toxicology 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 administration as before.

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

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

If you have any further questions about using this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

Situations that need to be monitored:

Severe allergic reactions

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

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

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

Plasimine may cause skin irritation.

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

Rarely, medications like Plasimine (which contain an antibiotic) can cause colon inflammation (pseudomembranous colitis), leading to diarrhea, usually with blood and mucus, stomach pain, and fever.

• If you experience 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 side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package 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 medication.

5. Storage of Plasimine

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

Store below 25°C.

Do not use this medication after the expiration date stated 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 notice that the ointment does not have a white or almost white color.

Discard any leftover product.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medications at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Plasimine

• 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 pack contents

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

Marketing authorization holder and manufacturer

Marketing authorization holder:

GlaxoSmithKline, S.A.

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

28760 Tres Cantos (Madrid)

Tel: +34 900 202 700

es-ci@gsk.com

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 package leaflet:March 2020.

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