Mupirox

Package Leaflet: Information for the Patient

Mupirox, 20 mg/g, Ointment

Mupirocin

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Mupirox and what is it used for
• 2. Important information before using Mupirox
• 3. How to use Mupirox
• 4. Possible side effects
• 5. How to store Mupirox
• 6. Package contents and other information

1. What is Mupirox and what is it used for

Mupirox is an ointment. The active substance of the medicine is the antibiotic mupirocin. The medicine is intended for topical use on the skin for the local treatment of bacterial skin infections caused by mupirocin-sensitive strains of Staphylococcus aureus, including methicillin-resistant strains, and other staphylococci and streptococci.

Indications for Use

Local treatment:

• impetigo, folliculitis, and furuncles caused by Staphylococcusaureus, other staphylococci, and streptococci;
• secondary skin infections.

2. Important Information Before Using Mupirox

When Not to Use Mupirox:

• in the nose or eyes.

Warnings and Precautions

Before starting to use Mupirox, discuss it with your doctor.
The medicine should always be used as directed by your doctor.
Protect your eyes and mucous membranes from contact with the medicine.
If the ointment gets into your eye, rinse it with water until the ointment is removed.
Do not use the medicine in the mouth or swallow it.
If you experience an allergic reaction or severe local irritation, stop using the medicine and contact your doctor immediately.
Prolonged use beyond the period recommended by your doctor may lead to the development of resistant microorganisms.
The medicine contains macrogol, which can be absorbed through open wounds or damaged skin and then excreted by the kidneys. Mupirox should not be used with other medicines containing macrogol, especially in patients with moderate or severe kidney impairment, due to the risk of absorbing large amounts of macrogol.

Children and Adolescents

Mupirox can be used in children.

Mupirox and Other Medicines

Tell your doctor about all medicines you are taking, or have recently taken, and about medicines you plan to take.
Do not use the ointment with other topical medicines, as this may lead to dilution resulting in reduced antibacterial activity and possible instability of mupirocin in the ointment.

Pregnancy, Breast-feeding, and Fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.
Pregnancy
There are no data on the effects of the medicine on the human fetus.
Do not use the medicine during pregnancy.
Breast-feeding
There is no information available on the excretion of mupirocin into breast milk.
Do not use the medicine during breast-feeding.

Driving and Using Machines

Mupirox does not affect the ability to drive or use machines.

3. How to Use Mupirox

This medicine should always be used as directed by your doctor. If you are unsure, ask your doctor or pharmacist.
The medicine is intended for topical use on the skin.
Apply a small amount of ointment to the affected area of the skin. The medicine is usually applied three times a day for up to 10 days.
A dressing can be applied to the treated area.
If there is no improvement within 3-5 days of treatment, contact your doctor.

Patients with Kidney Impairment

Use with caution in patients with moderate or severe kidney impairment.

Using More Mupirox Than Recommended

In case of overdose or if the medicine is swallowed, contact your doctor.

Missing a Dose of Mupirox

Do not use a double dose to make up for a missed dose.
If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The frequency of possible side effects listed below is defined as:

• common: occurs in 1 to 10 users in 100;
• uncommon: occurs in 1 to 10 users in 1,000;
• very rare: occurs in less than 1 user in 10,000.

Disorders of the Skin and Subcutaneous Tissue
Common: burning, itching, rash.
Uncommon: dry skin, sensitivity to touch, contact dermatitis, increased exudation.
Immune System Disorders
Very rare: general hypersensitivity reactions.

Reporting Side Effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products {current address, phone and fax number of the Department}
Website: https://smz.ezdrowie.gov.pl
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to Store Mupirox

Store below 25°C.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package Contents and Other Information

What Mupirox Contains

• The active substance is mupirocin 20 mg/g.
• The other ingredients are macrogol 3350 and macrogol 400.

What Mupirox Looks Like and Contents of the Package

Mupirox is a white ointment of uniform consistency.
Aluminum tubes containing 8 g, 15 g, or 30 g of ointment, in a cardboard box.

Marketing Authorization Holder

Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland

Manufacturer

EMO-FARM Sp. z o.o.
ul. Łódzka 52
95-054 Ksawerów
Date of last update of the leaflet: