MUPIROCIN ISDIN 20 mg/g OINTMENT

Introduction

Package Leaflet: Information for the User

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

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

Mupirocina ISDIN contains mupirocin. Mupirocin is an antibiotic capable of stopping the growth of certain microorganisms.

Antibiotics are used to treat bacterial infections and are not effective against viral infections.

It is essential that you 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 treatment, return it to the pharmacy for proper disposal. Do not throw medications down the drain or in the trash.

Mupirocina ISDIN is used to treat superficial skin infections such as impetigo, folliculitis, and furunculosis, as well as certain skin conditions (atopic dermatitis, eczematous dermatitis, and contact dermatitis) and traumatic lesions that can become infected, provided their extent is limited.

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

Do not use Mupirocina ISDIN

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

Warnings and Precautions

• do not use this ointment in the eyes or nasal passages. If the ointment accidentally enters the eyes, rinse them carefully with water to remove any remaining ointment.

• if you have moderate or severe kidney impairment, as this medication 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 kidney function.

• if during treatment you develop an allergic reaction or notice burning, itching, redness, dryness, or sensitivity in the application area of this medication. In this case, discontinue treatment and consult your doctor.

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

Consult your doctor or pharmacist before starting to use Mupirocina ISDIN.

Other Medications and Mupirocina ISDIN

Inform your doctor or pharmacist of any other medications you are taking, have recently taken, or may need to take.

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

Pregnancy, Breastfeeding, and Fertility

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 ISDIN should not be administered to pregnant women unless necessary.

Do not breastfeed while using Mupirocina ISDIN, as it may pass into breast milk and affect the baby. If Mupirocina ISDIN is used to treat nipple cracks, the area should be washed thoroughly before breastfeeding.

Driving and Using Machines

Mupirocina ISDIN does not affect the ability to drive or operate machines.

3. How to Use Mupirocina ISDIN 20 mg/g Ointment

Follow your doctor's instructions for administering this medication exactly. In case of doubt, consult your doctor or pharmacist again. This medication is not suitable for nasal administration.

The recommended dose is:

Adults and Children:

Apply two or three times a day for 5 to 10 days. Before application, wash your hands and the area to be treated carefully. Apply a small amount of ointment to the affected area. You can cover the area with a bandage or gauze.

This medication is for external use only (on the skin).

The dose for patients over 65 years old is the same as for adults, unless they have moderate or severe kidney impairment (see Warnings and Precautions).

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

If You Use More Mupirocina ISDIN 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 or the Toxicology Information Service, phone: 915620420, indicating the medication and the amount ingested.

If You Forget to Use Mupirocina ISDIN

If you forget to administer a dose, apply the next dose as soon as possible and continue administration as before. Do not administer a double dose to make up for forgotten doses.

If You Interrupt Treatment with Mupirocina ISDIN

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 the use of this medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, Mupirocina ISDIN can cause side effects, although not everyone will experience them.

Frequent: side effects that may affect up to 1 in 10 people:

o Localized burning sensation in the application area.

Uncommon: side effects that may affect up to 1 in 100 people:

o Itching, redness, stinging, and dryness localized in the application area.

o Cutaneous allergic reactions.

Rare: side effects that may affect up to 1 in 10,000 people:

o Systemic allergic reactions (affecting the entire body).

Reporting Side Effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: 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.

Do not store at a temperature above 25°C.

Once opened, do not store at a temperature above 25°C for more than 6 months.

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

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

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

6. Package Contents and Additional Information

Composition of Mupirocina ISDIN

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

Appearance of the Product and Package Contents

Mupirocina ISDIN is presented in an aluminum tube with a polyethylene cap, containing 15 or 30 grams of white ointment.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Isdin, S.A.

Provençals, 33

08019 Barcelona

Spain

Manufacturer:

Laboratorios Feltor, S.A.

C/ Roques Blanques, nº 3 y 5

Pol. Ind. Moli de les Planes

08470 – SANT CELONI (Barcelona)

Spain

or

Farmalider, S.A.

C/ Aragoneses, 15

28108 Alcobendas (Madrid)

Spain

Date of the Last Revision of this Package Leaflet: May 2018

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