MUPIROCIN GALENICUMDERMA 20 mg/g OINTMENT

Introduction

Package Leaflet: Information for the Patient

MupirocinaGalenicumDerma20 mg/g ointment

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 doubts, 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 side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What Mupirocina 20 mg/g ointment is and what it is used for
2. What you need to know before starting to use Mupirocina 20 mg/g ointment
3. How to use Mupirocina 20 mg/g ointment
4. Possible side effects
5. Storage of Mupirocina 20 mg/g ointment
6. Package Contents and Additional Information

1. What Mupirocina 20 mg/g ointment is and what it is used for

This medication contains mupirocina. Mupirocina is an antibiotic capable of stopping the growth of certain microorganisms.

This medication is used to treat superficial skin infections such as impetigo, folliculitis, and furunculosis, as well as certain skin diseases (atopic dermatitis, eczematous dermatitis, and contact dermatitis) and traumatic lesions that can become superinfected, as long as their extent is limited.

2. What you need to know before starting to use Mupirocina 20 mg/g ointment

Do not use Mupirocina 20 mg/g ointment

-if you are allergic to mupirocina or any of the other components of this medication (listed in section 6).

Warnings and Precautions

Consult your doctor or pharmacist before starting to use Mupirocina.

Do not use this ointment in the eyes or nasal passages. If the ointment accidentally enters the eyes, they should be carefully washed with water to remove any remaining ointment.

Do not use this medication with cannulas or near intravenous catheters.

This medication can cause skin irritation and allergic reactions. If during treatment you develop an allergic reaction or notice burning, itching, redness, dryness, or sensitivity in the area where this medication is applied, discontinue treatment, remove the applied cream, and consult your doctor as soon as possible.

If you have moderate or severe renal insufficiency, be especially careful with this medication since it contains a component called polyethylene glycol (macrogol) that, when applied to damaged skin, can be absorbed by the body, especially in the case of extensive lesions or open wounds, worsening renal function.

If you prolong treatment for more than 10 days, as this could lead to the emergence of resistant microorganisms.

Medications like Mupirocina Galenicumderma can cause inflammation of the colon (large intestine), leading to diarrhea, usually with blood and mucus, stomach pain, and fever (pseudomembranous colitis).

Other Medications and Mupirocina 20 mg/g ointment

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

Due to the lack of information, Mupirocina 20 mg/g ointment should not be administered to pregnant women unless the benefits outweigh the potential risks of treatment.

Do not breastfeed if you are using Mupirocina 20 mg/g ointment because it is unknown whether it passes into breast milk and could affect the baby. If Mupirocina 20 mg/g ointment is used to treat nipple cracks, the nipple should be washed well before breastfeeding.

Driving and Using Machines

Mupirocina does not affect the ability to drive or use machines.

Mupirocina contains Macrogol 400 and Macrogol 3350.

3. How to use Mupirocina 20mg/g ointment

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

Topical use. For external use only

The recommended dose is:

Adults and children:

One application two or three times a day for 5 to 10 days.

Patients with renal insufficiency

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

Elderly patients

The dose for patients over 65 years is the same as for adults unless they have moderate or severe renal insufficiency (see section 2 "Warnings and Precautions").

Mode of Employment:

Before application wash your handsand the area to be treated carefully.

Apply a small amountof ointment to the affected area.

You can cover the area with a bandage or gauze, unless your doctor tells you to leave the area uncovered.

If after three to five days of treatment you do not notice improvement, consult your doctor.

If you use more Mupirocina 20 mg/g ointment than you should

If you have used more ointment than you should, 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: 915620420, indicating the medication and the amount ingested.

If you forget to use Mupirocina 20 mg/g ointment

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 it is indicated by your doctor, even if you feel better. If you do, the infection may recur.

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not all people experience them.

The frequent side effects described in more than 1 in 100 patients but in less than 1 in 10 who use this medication are:

• Localized burning in the application area.

The uncommon side effects described in more than 1 in 1,000 patients but in less than 1 in 100 are:

• Itching, redness, stinging, and dryness localized in the application area.
• Cutaneous allergic reactions.

The very rare side effects described in less than 1 in 10,000 patients are:

• Systemic allergic reactions (affecting the entire body).

Reporting Side Effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Medication Pharmacovigilance System https://www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Mupirocina 20 mg/g ointment

Keep this medication out of sight and reach of children.

Store below 25°C.

After the first opening, use within 15 days.

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

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

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Mupirocina 20 mg/g ointment

• The active ingredient is mupirocina. Each gram of ointment contains 20 mg of mupirocina.
• The other components are macrogol 400 (polyoxyethylene glycol) and macrogol 3350 (polyoxyethylene glycol).

Appearance of the Product and Package Contents

Mupirocina is a whitish ointment; it is available in a 15g or 30g tube.

Marketing Authorization Holder and Manufacturer

Galenicum Derma, S.L.

Crta N-1, Km 36,

28750 San Agustin de Guadalix (Madrid)

Spain

Manufacturer

DELPHARM HUNINGUE S.A.S

26 rue de la Chapelle

68330 Huningue

France

VETPROM AD

26 Otez Paissij Str.

Radomir, 2400

Bulgaria

Date of the Last Revision of this Package Leaflet:November 2024

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