Mupirocin Farmalider 20 mg/g ointment

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Mupirocina Farmalider 20 mg/g ointment

Mupirocina

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 could harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

Leaflet contents:

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

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

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

Mupirocina Farmalider 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 may become secondarily infected, provided their extent is limited.

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

Do not use Mupirocina Farmalider

• 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 gets into the eyes accidentally, wash them carefully with water until all traces of the ointment are removed.

• if you have moderate or severe kidney 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 at the site of application of this medicine. 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.

Use of Mupirocina Farmalider with other medicines

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

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

Pregnancy and breastfeeding

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 Farmalider should generally not be administered to pregnant women unless clearly necessary.

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

Driving and use of machinery

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

3. How to use Mupirocina Farmalider 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 (there is another formulation available for nasal use).

The recommended dose is:

Adults and children:

Apply twice or three times daily 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. The area may be covered with a dressing 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 Farmalider than you should

If you have used more ointment than you should have, consult your doctor or pharmacist.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or contact the Toxicology Information Service, telephone: 915620420, indicating the medicine and the amount ingested.

If you forget to use Mupirocina Farmalider

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 missed doses.

If you stop using Mupirocina Farmalider

Do not stop treatment earlier than instructed 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 Farmalider can cause adverse effects, although not everyone will experience them.

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

• Localized burning at the application site.

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

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

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

• Systemic allergic reactions (affecting the whole body).

If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

5. Storage of Mupirocina Farmalider 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, for longer than 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 in appearance.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE collection point at your pharmacy. If in doubt, 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 Farmalider

• The active substance 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 contents of the pack

Mupirocina Farmalider is presented in an aluminum tube with nozzle and cap, containing 15 or 30 grams of white ointment.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

FARMALIDER, S.A.

C/ La Granja 1

28108 Alcobendas (MADRID)

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, 2

28108 Alcobendas (Madrid)

Spain

Date of the most recent revision of this leaflet: March 2019

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