Package leaflet: Information for the user

MUPIDER NASALE 20 mg/g nasal ointment

mupirocin
Equivalent medicine
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What MUPIDER NASALE is and what it is used for

MUPIDER NASALE 20 mg/g nasal ointment ("MUPIDER NASALE" in this leaflet)
contains the active substance mupirocin calcium salt. MUPIDER NASALE is an antibiotic
nasal ointment.
It is used:

to eliminate a group of bacteria present in the nose called "staphylococci"
this group includes methicillin-resistant Staphylococcus aureus (MRSA)
the ointment is for nasal use only.

2. What you need to know before using MUPIDER NASALE

Do not use MUPIDER NASALE:

if you are allergic (hypersensitive) to mupirocin calcium salt, mupirocin, or to any of the other ingredients of this medicine (listed in section 6).

Newborns must not be treated with MUPIDER NASALE to avoid the risk of the product being
aspirated into the trachea.
If you are unsure whether this applies to you, do not use this medicine. Speak with your doctor,
pharmacist, or nurse before using MUPIDER NASALE.
Warnings and precautions
Consult your doctor or pharmacist before using MUPIDER NASALE.
MUPIDER NASALE may cause severe skin reactions or allergic reactions. See “Conditions to
which attention should be paid” in section 4.
With prolonged use of MUPIDER NASALE, infections caused by non-susceptible organisms may develop. In such cases, consult your doctor, pharmacist, or nurse.
Keep the ointment away from the eyes.

In case of accidental contact with the eyes, rinse thoroughly with plenty of water.

Other medicines and MUPIDER NASALE
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Driving and using machines
It is unlikely that MUPIDER NASALE will affect your ability to drive or operate machinery.

3. How to use MUPIDER NASAL

Use this medicine exactly as directed by your doctor. If you have any doubts,
consult your doctor or pharmacist.
Dosage
Adults (including elderly) and children from one year of age:
Apply MUPIDER NASAL two to three times a day to the front part of the nostrils.
Children under one year of age:
MUPIDER NASAL must not be used in children under one year of age.
Patients with renal impairment:
No dose adjustment is necessary.
Patients with hepatic impairment:
No dose adjustment is necessary.
How to use the medicine
MUPIDER NASAL is generally applied inside the nose two to three times a day.

Wash and dry your hands.
Apply a small amount of MUPIDER NASAL, approximately the size of a match head, to the little finger.
Apply it inside one nostril.
Repeat steps 2 and 3 for the other nostril.
Press gently on both sides of the nose to help spread the ointment within the nostril.
Close the tube with the cap and wash your hands.

A cotton swab may be used instead of the little finger to apply the ointment,
particularly in children or severely ill patients.
How long to use MUPIDER NASAL?
Use MUPIDER NASAL for the length of time prescribed by your doctor. If you have any doubts, consult your
doctor, pharmacist or nurse. Normally, bacteria are eliminated from the nose within 5–7 days of starting treatment.
If you ingest MUPIDER NASAL
In case of accidental ingestion, seek advice from your doctor, pharmacist or nurse.
If you forget to use MUPIDER NASAL

If you forget to apply MUPIDER NASAL, apply it as soon as you remember.
If the next dose is due within one hour, skip the missed dose.
Do not use a double dose to make up for a forgotten dose.

If you stop treatment with MUPIDER NASAL
If you stop using MUPIDER NASAL too early, it is possible that not all bacteria
have been eliminated or that they may continue to grow. Ask your doctor, pharmacist or nurse
when to stop using the ointment.
If you have any questions about the use of this medicine, consult your doctor, pharmacist or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Conditions to watch for

Severe skin reactions or allergies: These are very rare events in people using MUPIDER NASALE. Signs include:

raised, itchy rash
swelling, sometimes of the face or mouth, leading to breathing difficulties
collapse or loss of consciousness.

Contact a doctor immediately if you experience any of these symptoms. Stop using MUPIDER NASALE.

If you develop a severe skin reaction or allergy:
wash off the ointment
stop using it, and
inform your doctor as soon as possible.

In rare cases, medicines such as MUPIDER NASALE may cause inflammation of the colon (large intestine), resulting in diarrhoea, usually with blood and mucus, stomach pain and fever (pseudomembranous colitis).

Inform your doctor as soon as possible if you experience any of these symptoms.

The following side effects may occur with this medicine:

Uncommon (may affect up to 1 in 100 people)

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

Very rare (may affect up to 1 in 10,000 people)

Some people may develop a severe skin reaction or allergy. Signs may include rash, itching or irritation.

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via
Website:
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store MUPIDER NASAL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the tube or carton after "Exp.". The expiry date refers to the last day of that month.
Do not store above 25°C.
After first opening, the contents may be used for up to 7 days.
MUPIDER NASAL is a homogeneous whiteish ointment. Do not use it if it appears different from normal.
Do not dispose of any medicine 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 MUPIDER NASALE contains

The active substance is mupirocin as mupirocin calcium salt. 100 g of nasal ointment contains 2.00 g of mupirocin as mupirocin calcium salt. 1 g of nasal oint combust contains 20 mg of mupirocin as mupirocin calcium salt.
The other components are white vaseline and glycerol esters.

Description of the appearance of MUPIDER NASALE and contents of the pack

MUPIDER NASALE is a homogeneous, whitish nasal ointment.
MUPIDER NASALE is available in tubes of 3 g or 5 g. Each tube is contained in a box.

Marketing Authorisation Holder and Manufacturer
INFECTOPHARM Arzneimittel und Consilium GmbH
Von-Humboldt-Str. 1
64646 Heppenheim
Germany
This medicinal product is authorised in the European Economic Area countries with 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: MupiNa 20 mg/g pomada nasal
Slovakia: Mupina 20 mg/g nosová masť
Spain: MupiNa 20 mg/g pomada nasal
Czech Republic: Mupina
Hungary: Mupirocin InfectoPharm 20 mg/g orrkenőcs
United Kingdom: Mupirocin 20 mg/g Nasal Ointment