Leaflet: information for the user

Mupirocina ISDIN 20 mg/g ointment

Read this leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What isMupirocina ISDIN 20 mg/g ointmentand what it is used for

2. What you need to know before you start usingMupirocina ISDIN 20 mg/g ointment

3. How to useMupirocina ISDIN 20 mg/g ointment

4. Possible side effects

5. Storage ofMupirocina ISDIN 20 mg/g ointment

6. Contents of the pack and additional information

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

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 injuries that can become infected, provided their extent is limited.

Do not use Mupirocina ISDIN

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

Warnings and precautions

• do not use this ointment on the eyes or nasal passages. If the ointment accidentally gets into the eyes, wash them thoroughly with water to remove any remaining ointment.

• if you have moderate or severe renal insufficiency, 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 renal function.

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

• if treatment is prolonged for more than 10 days, as this could lead to the appearance of resistant microorganisms.

Consult your doctor or pharmacist before starting to use Mupirocina ISDIN

Other medications and Mupirocina ISDIN

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

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

Pregnancy, breastfeeding, and fertility

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

Due to lack of information, Mupirocina ISDIN is generally not recommended for pregnant women unless necessary.

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

Driving and operating machinery

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

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again. This medication is not suitable for nasal administration.

The recommended dose is:

Adults and children :

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

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

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

If after three to five days of treatment you do not notice improvement, 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 Toxicological 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 one as soon as possible and continue administration as before. Do not administer a double dose to compensate for the missed doses.

If you interrupt treatment with Mupirocina ISDIN

Do not discontinue treatment before the recommended time by your doctor, even if you feel better. If you do, the infection may recur.

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

Like all medications, Mupirocina ISDIN may produce adverse effects, although not all people will experience them.

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

orLocalized burning in the application area.

Rare: Adverse effects that may affect up to 1 in 100 people:

orLocalized itching, redness, stinging, and dryness.

orDermatological allergic reactions.

Very rare: Adverse effects that may affect up to 1 in 10,000 people:

orSystemic allergic reactions (affecting the entire body).

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 the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: 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.

Do not store at a temperature above 25°C.

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

Do not use this medication after the expiration date appearing on the carton and tube. 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 disposed of through drains or in the trash. Deposit the containers and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need.This will help protect the environment.

Composition of Mupirocina ISDIN

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

-The other components (excipients) are macrogol 400 and polietilenglicol 3350.

Appearance of the product and contents of the packaging

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Isdin, S.A.

Provençals, 33

08019 Barcelona

Spain

Responsible for manufacturing:

Laboratorios Feltor, S.A.

C/ Roques Blanques, nº 3 and 5

Pol. Ind. Moli de les Planes

08470 – SANT CELONI (Barcelona)

Spain

“o”

Farmalider, S.A.

C/ Aragoneses, 15

28108 Alcobendas (Madrid)

Spain

Last review date of this leaflet: May 2018

The 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/.