Product Information for the Patient

MupirocinGalenicumDerma20 mg/g Ointment

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

• Keep this product information, 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 should not be given to others, even if they 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 product information. See section 4.

1. What is Mupirocin 20 mg/g Ointment and for what it is used

2. What you need to know before starting to use Mupirocin 20 mg/g Ointment

3. How to use Mupirocin 20 mg/g Ointment

4. Possible adverse effects

5. Storage of Mupirocin 20 mg/g Ointment

6. Contents of the package and additional information

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 impétigo, foliculitis and forunculosis, as well as certain skin conditions (atopic dermatitis, eczematous dermatitis and contact dermatitis) and traumatic injuries that can become overinfected, provided their extent is limited.

Do not use Mupirocina 20 mg/g ointment

-if you are allergic to mupirocina or to 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 gets into the eyes, wash them carefully with water to remove any remaining ointment.

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

This medication may 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 see your doctor as soon as possible.

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

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

Medications like Mupirocina Galenicumderma may cause inflammation of the colon (large intestine), causing 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 used recently, 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 treatment of the same area of application.

Pregnancy and breastfeeding

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

Due to lack of information, Mupirocina 20 mg/g ointment is generally not recommended for pregnant women unless the benefits outweigh the possible risks of treatment.

Do not breastfeed while 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 cracks on the nipple, the nipple should be washed well before breastfeeding.

Driving and operating machinery

Mupirocina does not affect the ability to drive or operate machinery.

Mupirocina contains Macrogol 400 and Macrogol 3350.

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

Skin use. Exclusively for external use

The recommended dose is:

Adults and children:

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

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

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

Method of use:

Before applicationwash the hands and the affected area carefully.

Applya small amountof ointment to the affected area.

You may 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 Toxicological Information Service, phone: 915620420, indicating the medication and the amount ingested.

If you forgot 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 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 product, ask your doctor or pharmacist.

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

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

• Localized burning in the application area.

The infrequent side effects described in more than 1 in 1,000 patients but in fewer 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 fewer than 1 in 10,000 patients are:

• Systemic allergic reactions (affecting the entire body).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is about possible adverse effects that do not appear in this prospectus. You can also report them directly through the Human Medicines Pharmacovigilance System https://www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Store below 25°C.

Use within 15 days after the first opening.

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 notice the ointment does not have a whitish color.

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

Mupirocina 20 mg/g Ointment Composition

•The active ingredient is mupirocina. Each gram of ointment contains 20 mg of mupirocina.

•The other components are macrogol 400 (polyoxylglycerides) and macrogol 3350 (polyoxylglycerides).

Product Appearance and Packaging Contents

Mupirocina is a white to off-white ointment; it is available in a 15 g tube.

Marketing Authorization Holder and Responsible Manufacturer

Galenicum Derma, S.L.

Crta N-1, Km 36,

28750 San Agustin de Guadalix (Madrid)

Spain

Responsible Manufacturer

DELPHARM HUNINGUE S.A.S

26 rue de la Chapelle

68330 Huningue

France

VETPROM AD

26 Otez Paissij Str.

Radomir, 2400

Bulgaria

SAG Manufacturing, S.L.U.

Ctra. N-1, km 36

28750 San Agustín del Guadalix (Madrid)

Spain

Last Review Date of this Leaflet:November 2024

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