Package leaflet: Information for the user

Mubactin, 20 mg/g, nasal ointment
Mupirocin
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual only. Do not pass it on to others. It may harm someone else even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

What Mubactin is and what it is used for
Important information before using Mubactin
How to use Mubactin
Possible side effects
How to store Mubactin
Contents of the pack and other information

1. What Mubactin is and what it is used for
Mubactin nasal ointment contains an antibiotic called mupirocin, in the form of mupirocin calcium (micronized).
Mubactin is used to eliminate bacteria called Staphylococci from the nose. This group includes MRSA (methicillin-resistant Staphylococcus aureus strains).
Mubactin is intended for nasal use only.

2. Important information before using Mubactin

When not to use Mubactin
Do not use Mubactin if you are allergic to mupirocin or to any of the other ingredients of this medicine (listed in section 6).
If in doubt about using this medicine, consult your doctor or pharmacist.

Warnings and precautions

Do not use in newborns and infants.
Do not apply Mubactin to the eyes or near the eyes. Avoid contact with the eyes. If the ointment gets into the eye, rinse thoroughly with water until all traces of the ointment are removed.
Do not apply Mubactin to the mouth or swallow it.

Mubactin and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, including those obtained without a prescription, herbal medicines, and any medicines you plan to take.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.

3. How to use Mubactin

This medicine should always be used according to the doctor's or pharmacist's instructions. If in doubt,
consult your doctor or pharmacist.
How to use the medicine
Mubactin should be applied into the nose twice daily.

Wash and dry your hands.
Squeeze out a small amount of ointment, about the size of a match head, onto the little finger.
Apply it inside one nostril.
Repeat steps 2 and 3 for the other nostril.
Press the sides of the nose gently to evenly spread the ointment within the nostrils.
Close the tube tightly and wash your hands.

Children and elderly patients
Instead of using the little finger, cosmetic swabs may be used to apply the medicine into the nose.
Special precautions should be taken in these patients. Mubactin must not be used in newborns and infants.
How long to use Mubactin
Use Mubactin for as long as directed by your doctor. If in doubt, consult your doctor or pharmacist.
Usually, bacteria in the nose are eliminated after 3–5 days of treatment.
Do not use Mubactin for longer than 10 days.
Use of more than the recommended dose of Mubactin
If more than the recommended amount of Mubactin has been used, contact your doctor or pharmacist.
Carefully remove any excess ointment.
If Mubactin has been swallowed, contact a doctor immediately and inform them what and how much was swallowed.
Missed dose of Mubactin
If the patient forgets to apply the medicine, it should be applied as soon as remembered. If the next dose is due within one hour, the missed dose should be skipped.
Do not apply a double dose to make up for a missed dose.
Stopping the use of Mubactin
If the patient stops using Mubactin too early, not all bacteria may be eliminated or they may continue to multiply.
Ask your doctor or pharmacist when to stop using the ointment.
If in doubt 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 they do not occur in everyone.
Below are listed the possible adverse reactions associated with this medicine.
Uncommon (may occur in 1 in 100 to 1 in 1000 patients):

itching, redness, burning, tingling or stinging in the nose,
catarrh.

Very rare (may occur in fewer than 1 in 10,000 patients):

skin hypersensitivity reactions (rash, itching, redness, pain),
systemic allergic reactions, such as:
- generalized rash, urticaria,
- angioedema (swelling, sometimes affecting the face and lips, potentially leading to breathing difficulties),
- fainting or loss of consciousness.

If any of these symptoms occur, discontinue use of the medicine immediately and
contact a doctor without delay.
If skin irritation or hypersensitivity occurs:

remove the ointment from the skin,
discontinue use of the medicine,
inform the treating physician as quickly as possible.

In rare cases, medicines such as Mubactin nasal ointment may cause inflammation of the colon (large intestine) – manifested by diarrhea, usually bloody and containing mucus, abdominal pain, and fever (pseudomembranous colitis).
If any of the above symptoms occur, contact a doctor as quickly as possible.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw,
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Mubactin

Keep this medicine out of the sight and reach of children.
Do not store above 30°C. Do not store in the refrigerator or freeze.
Use within 14 days after first opening the tube.
Do not use this medicine after the expiry date stated on the packaging following the "EXP".
"Lot" is the product batch number.
Do not use Mubactin if it appears different from normal (see description in section 6).
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. Contents of the pack and other information

What Mubactin contains

The active substance is mupirocin in the form of mupirocin calcium (micronized). Each gram of nasal ointment contains 20 mg of mupirocin.
Other ingredients: white soft paraffin, softisan 649.

What Mubactin looks like and contents of the pack
Mubactin is a white, homogeneous nasal ointment.
The medicine is available in tubes containing 3 g of ointment, packed in a cardboard box.
Marketing Authorization Holder:
Solinea Sp. z o.o.
Elizówka, Szafranowa 6
21-003 Ciecierzyn
Poland
Tel.: +48 81 463 48 82
[logo of the marketing authorization holder]
Manufacturer:
Mako Pharma Sp. z o.o.
Władysława Reymonta 2
05-092 Dziekanów Leśny
Poland
Medicofarma S.A.
Tarnobrzeska 13
26-613 Radom
Poland