Mupirox
Poland
Table of Contents
Package leaflet: Information for the patient
Mupirox, 20 mg/g, ointment
Mupirocin
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.
- Keep this leaflet for future reference.
- If you have any questions, please consult your doctor or pharmacist.
- This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
- If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.
Leaflet contents:
- What Mupirox is and what it is used for
- Important information before using Mupirox
- How to use Mupirox
- Possible side effects
- How to store Mupirox
- Package contents and other information
1. What Mupirox is and what it is used for
Mupirox is an ointment. The active substance is the antibiotic mupirocin. The medicine is intended
for topical use in the local treatment of bacterial skin infections caused by strains sensitive to
the mupirocin antibiotic, including Staphylococcus aureus (including methicillin-resistant strains),
as well as other staphylococci and streptococci.
Indications for use
Local treatment of:
- Impetigo, folliculitis, and furuncles caused by Staphylococcus aureus, other staphylococci, and streptococci;
- Secondary skin infections.
2. Important information before using Mupirox
When not to use Mupirox:
- if the patient is allergic to mupirocin or to any of the other ingredients of this medicine (listed in section 6);
- in the nose or eyes.
Warnings and precautions
Before starting treatment with Mupirox, discuss it with your doctor.
Always use this medicine exactly as prescribed by your doctor.
Protect the eyes and mucous membranes from contact with the medicine.
If ointment gets into the eye, rinse it thoroughly with water until all traces of ointment are removed.
Do not apply the medicine inside the mouth or swallow it.
If an allergic reaction or severe local irritation occurs, stop using the medicine and contact your doctor immediately.
Prolonged use beyond the period recommended by your doctor may lead to the development of drug-resistant microorganisms.
This medicine contains polyethylene glycol (PEG), which may be absorbed through open wounds or damaged skin and subsequently excreted by the kidneys. Mupirox should not be used together with other medicines containing polyethylene glycol, especially in patients with moderate to severe kidney dysfunction, due to the risk of absorption of large amounts of polyethylene glycol.
Children and adolescents
Mupirox may be used in children.
Mupirox and other medicines
Inform your doctor about all medicines currently or recently used, as well as any medicines the patient intends to use.
Do not use this ointment simultaneously with other topical medicines, as this may cause dilution, resulting in reduced antibacterial activity and possible loss of mupirocin stability in the ointment.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.
Pregnancy
There are no data available on the effects of this medicine on the human fetus.
Do not use this medicine during pregnancy.
Breastfeeding
There is no information available on whether mupirocin passes into breast milk.
Do not use this medicine during breastfeeding.
Driving and operating machinery
Mupirox has no effect on the ability to drive or operate machinery.
3. How to use Mupirox
This medicine should always be used exactly as directed by the physician. In case of doubts, consult
your doctor or pharmacist.
This medicine is intended for topical application to the skin.
Apply a small amount of the ointment to the affected area of the skin. The medicine is usually applied
three times daily for up to 10 days.
A dressing may be applied over the treated area.
If no improvement is observed within 3 to 5 days of treatment, consult your doctor.
Patients with renal function disorders
Use with caution in patients with moderate or severe renal impairment.
Use of a higher than recommended dose of Mupirox
In case of overdose or accidental ingestion, seek medical advice immediately.
Missed dose of Mupirox
Do not apply a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
The frequency of the possible adverse reactions listed below is defined as follows:
- Common: occurs in 1 to 10 out of 100 people;
- Uncommon: occurs in 1 to 10 out of 1,000 people;
- Very rare: occurs in less than 1 out of 10,000 people.
Disorders of the skin and subcutaneous tissue
Common: burning sensation, itching, rash.
Uncommon: dry skin, tenderness, contact dermatitis, increased exudation.
Immune system disorders
Very rare: generalized hypersensitivity reactions.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed
in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring Adverse Drug Reactions
of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
{current address, telephone and fax numbers of the above Department}
Website: https://smz.ezdrowie.gov.pl
By reporting adverse reactions, additional information on the safety of this medicine can be collected.
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 container. The expiry date refers to the last day of the stated month.
Medicines must 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. Contents of the package 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 pack
Mupirox is a white, homogeneous ointment.
Aluminium tubes containing 8 g, 15 g, or 30 g of ointment, in a cardboard carton.
Marketing Authorisation Holder
Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland
Manufacturer
EMO-FARM Sp. z o.o.
Łódzka 52
95-054 Ksawerów