Mupirocin ISDIN 20 mg/g ointment

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Mupirocin ISDIN 20 mg/g ointment

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

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

Contents of the leaflet

1. What Mupirocin ISDIN 20 mg/g ointment is and what it is used for
2. What you need to know before using Mupirocin ISDIN 20 mg/g ointment
3. How to use Mupirocin ISDIN 20 mg/g ointment
4. Possible adverse effects
5. How to store Mupirocin ISDIN 20 mg/g ointment
6. Contents of the pack and other information

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

Mupirocina ISDIN contains mupirocina. Mupirocina 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 important that you follow your doctor's instructions regarding dose, dosing interval, and duration of treatment.

Do not store or reuse this medicine. If you have any antibiotic left over after completing treatment, return it to the pharmacy for proper disposal. Do not dispose of medicines down the drain or in the household waste.

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 may become secondarily infected, provided their extent is limited.

2. What you need to know before using Mupirocina ISDIN 20 mg/g ointment

Do not use Mupirocina ISDIN

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

Warnings and precautions

• do not use this ointment in the eyes or nasal passages. If the ointment accidentally gets into the eyes, rinse them carefully with water until all traces of ointment are removed.

• if you have moderate or severe renal impairment, as this medicine contains a component called polyethylene glycol (macrogol) which, when applied to damaged skin, may be absorbed into the body, especially in cases of extensive lesions or open wounds, potentially worsening kidney function.

• if you develop an allergic reaction during treatment, or experience burning, itching, redness, dryness, or sensitivity in the area where the medicine has been applied. In such cases, stop treatment and consult your doctor.

• if you extend treatment beyond 10 days, as this may lead to the emergence of resistant microorganisms.

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

Other medicines and Mupirocina ISDIN

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

You should not use this medicine simultaneously with other products intended for treatment of the same application site.

Pregnancy, breastfeeding and fertility

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

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

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

Driving and using machines

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

3. How to use Mupirocina ISDIN 20 mg/g ointment

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

The recommended dose is:

Adults and children:

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

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

The dose for patients over 65 years of age is the same as for adults unless they have moderate or severe renal impairment (see Warnings and precautions).

If there is no 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 contact the Toxicology Information Service at telephone number: 915620420, indicating the medicine and the amount ingested.

If you forget to use Mupirocina ISDIN

If you forget to apply a dose, apply the next dose as soon as possible and continue treatment as before. Do not apply a double dose to make up for a missed dose.

If you stop using Mupirocina ISDIN

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

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

4. Possible adverse effects

Like all medicines, Mupirocina ISDIN may produce adverse effects, although not everyone experiences them.

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

• Localized burning at the site of application.

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

• Itching, redness, stinging, and dryness at the site of application.
• Skin allergic reactions.

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

• Systemic allergic reactions (affecting the whole body).

Reporting of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Mupirocin 20 mg/g ointment

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

Do not store above 25°C.

After opening, do not store above 25°C and discard after a maximum of 6 months.

Do not use this medicine after the expiry date stated on the carton and tube. The expiry date refers to the last day of the month indicated.

Do not use this medicine if you notice that the ointment is not white or off-white in appearance.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Mupirocina ISDIN

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

Appearance of the product and contents of the pack

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 and 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 most recent review of this leaflet: May 2018

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.