Package leaflet: Information for the user

Mupina, 20 mg/g, nasal ointment
mupirocin
Please read all of this leaflet carefully before 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 further questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the leaflet

What Mupina is and what it is used for
What you need to know before you use Mupina
How to use Mupina
Possible side effects
How to store Mupina
Contents of the pack and other information

1. What Mupina is and what it is used for

Mupina, 20 mg/g, nasal ointment (referred to as "Mupina" in this leaflet) contains the active substance calcium mupirocin. Mupina is a nasal antibiotic ointment.
This medicine is used:

to eliminate bacteria called Staphylococcus from the nose.
this group includes MRSA (methicillin-resistant Staphylococcus aureus).
this ointment is for nasal use only.

2. Important information before using Mupina medicine

When not to use Mupina medicine:
if the patient is allergic (hypersensitive) to calcium mupirocin, mupirocin, or
any of the other ingredients of this medicine (listed in section 6).
Mupina medicine must not be used in infants to avoid inhalation into the upper respiratory tract and choking.
If in doubt whether this applies to the patient, this medicine should not be used. Before
starting to use Mupina medicine, discuss this with a doctor, nurse, or
pharmacist.
Warnings and precautions
Before starting to use Mupina medicine, discuss this with a doctor or pharmacist.
pal-mupirocin-nasal-3252000-pl-9-0
Mupina medicine may cause severe skin reactions and allergies. See "Conditions to be aware of" in section 4.
Infections caused by resistant organisms may develop if Mupina medicine is used for a prolonged period. In such a case, inform your doctor, pharmacist, or
nurse.
Avoid contact of the ointment with the eyes.

If the ointment accidentally gets into the eyes, rinse thoroughly with water.

Mupina medicine and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently using or has recently used, as well as any medicines the patient plans to use.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Driving and operating machinery
It is unlikely that Mupina medicine will affect the ability to drive or
operate machinery.

3. How to use Mupina

This medicine should always be used as directed by the physician. In case of doubt, consult
your doctor or pharmacist.
Dosage
Adults (including elderly patients) and children over one year of age:
Mupina should be applied into the nose two to three times daily.
Children under one year of age:
Mupina must not be used in children under one year of age.
Patients with renal impairment:
Dose adjustment is not necessary.
Patients with hepatic impairment:
Dose adjustment is not necessary.
How to use this medicine
Mupina should be applied into the nose two to three times daily.

Wash and dry your hands.
Place a small amount of Mupina ointment, approximately the size of a match head, on the little finger.
Insert it into one nostril.
Repeat steps 2 and 3 for the other nostril.
Press the sides of the nose together gently to spread the ointment inside the nostrils.
Replace the cap on the tube and wash your hands.

Instead of using the little finger, a cotton swab may be used to apply the ointment,
especially in young children or seriously ill patients.
How long to use Mupina
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Mupina should be used for as long as directed by the physician. In case of doubt, consult
your doctor, nurse, or pharmacist. Usually, bacteria are eliminated from the nose within
5–7 days of starting treatment.
Accidental ingestion of Mupina
If any amount of the ointment is swallowed, consult your doctor, nurse, or pharmacist immediately.
Missed dose of Mupina

If the patient forgets to apply Mupina, apply it as soon as they remember.
If the next scheduled dose is due within one hour, skip the missed dose.
Do not apply a double dose to make up for a missed dose.

Stopping Mupina treatment
If the patient stops using Mupina too early, not all bacteria may be killed, or they may continue to multiply.
Consult your doctor, nurse, or pharmacist before stopping the ointment.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
Conditions requiring attention
Severe skin reactions or allergies:
These are very rare in people using Mupina. Symptoms include:

raised, itchy rash
swelling, sometimes of the face or lips, causing difficulty in breathing
fainting or loss of consciousness.

If any of these symptoms occur, seek medical advice immediately.
Stop using Mupina.

If a severe skin reaction or allergy occurs:
wash off the ointment
discontinue its use, and
inform your doctor as soon as possible.

In rare cases, medicines such as Mupina may cause inflammation of the colon (large intestine), leading to diarrhoea, usually with blood and mucus, abdominal pain, and fever (pseudomembranous colitis).
If any of these symptoms occur, contact your doctor immediately.

The following adverse reactions may occur during treatment with this medicine:
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Not very common (may occur in fewer than 1 in 100 people):

Itching, redness, burning, tingling, or stinging in the nose.

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

In some individuals, a skin reaction or allergy may occur in a severe form. Symptoms may include, among others: rash, itching, redness, or pain.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +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 this medicine.

5. How to store Mupina

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the tube or carton, following “Expiry” or “EXP”. The expiry date refers to the last day of the stated month.
Do not store above 25°C.
Shelf life after first opening of the tube: 7 days.
Mupina is a smooth, whitish ointment. Do not use if it appears different from usual.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This helps protect the environment.

6. Contents of the pack and other information

What Mupina contains

The active substance is mupirocin in the form of mupirocin calcium. 100 g of nasal ointment contains 2.00 g of mupirocin as mupirocin calcium. 1 g of nasal ointment contains 20 mg of mupirocin as mupirocin calcium.
The other ingredients are: white soft paraffin and bis-diglycerol polyacyladipate-2.

What Mupina looks like and contents of the pack

Mupina is a smooth, whitish nasal ointment.
Mupina is available in tubes containing 3 g or 5 g of ointment. Each tube is packed in a cardboard box.

Marketing Authorisation Holder and Manufacturer
INFECTOPHARM Arzneimittel und Consilium GmbH
Von-Humboldt-Straße 1
64646 Heppenheim
pal-mupirocin-nasal-3252000-pl-9-0
Germany
For further information, please contact the representative of the
Marketing Authorisation Holder:
SOLPHARM Sp. z o.o.
ul. Zakątek 1
05-270 Marki
Tel.: + 48 22 616 28 08
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Germany: Mupirocin InfectoPharm 20 mg/g Nasensalbe
France: MupiNa 2 %, pommade nasale
Greece: MUPINA
Italy: MUPIDER NASALE
Netherlands: Mupirocine InfectoPharm, 20 mg/g, neuszalf
Austria: Mupirocin InfectoPharm 20 mg/g Nasensalbe
Poland: Mupina
Portugal: Mupirocina Infectopharm Nasal
Slovakia: Mupina 20 mg/g nosová masť
Spain: Bacnas 20 mg/g pomada nasal
Czech Republic: Mupina
Hungary: Mupirocin InfectoPharm 20 mg/g orrkenőcs
United Kingdom: Mupirocin 20 mg/g Nasal Ointment