MUPIROCIN FARMALIDER 20 mg/g OINTMENT

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 mupirocina 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, wash 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 can be absorbed by the body when applied to damaged skin, especially in the case of extensive lesions or open wounds, worsening kidney function.

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

Using Mupirocina Farmalider with other medications

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

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

Pregnancy and Breastfeeding

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 Farmalider should not be administered to pregnant women unless necessary.

Do not breastfeed if you are using Mupirocina Farmalider, as it may pass into breast milk and affect the baby. If you use Mupirocina Farmalider to treat nipple cracks, wash the area thoroughly before breastfeeding.

Driving and Using Machines

Mupirocina Farmalider does not affect the ability to drive or use machines.

3. How to use Mupirocina Farmalider 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 (there is another formulation 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 Farmalider 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 Farmalider

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 Farmalider

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

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

4. Possible Side Effects

Like all medications, Mupirocina Farmalider can cause side effects, although not everyone experiences them.

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

• Localized burning sensation in the application area.

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

• Itching, redness, stinging, and dryness localized in the application area.
• Cutaneous allergic reactions.

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

• Systemic allergic reactions (affecting the entire body).

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

5. Storage of Mupirocina Farmalider 20 mg/g Ointment

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

Do not store above 25°C.

Once opened, do not store above 25°C for a maximum of 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 away down the drain or in the trash. Deposit the packaging and unused medications in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Mupirocina Farmalider

• The active ingredient 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 Package Contents

Mupirocina Farmalider is presented in an aluminum tube with a 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 y 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 Last Revision of this Package Leaflet: March 2019

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/