Package leaflet: Information for the user

MUPIDER 20 mg/g ointment

mupirocin
Generic 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 or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
If any adverse reaction occurs, including any not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:

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

1. What MUPIDER is and what it is used for

MUPIDER 20 mg/g ointment (referred to as 'MUPIDER' in this leaflet) contains the active substance called mupirocin.
MUPIDER is an antibiotic ointment intended for topical use on the skin only.
It is used in adults, adolescents, children and infants aged 8 weeks and older:
to treat skin infections such as

infection of the hair follicles with formation of pus-filled pustules ("folliculitis"),
a contagious skin infection with blisters and crusts, called "impetigo", or
recurrent boils ("furunculosis"). to kill various bacteria causing other skin infections, such as Staphylococci, Streptococci and E. coli. This group includes MRSA (methicillin-resistant Staphylococcus aureus) bacteria.

2. What you need to know before using MUPIDER

Do not use MUPIDER
if you are allergic (hypersensitive) to mupirocin or to any of the other ingredients of this
medicinal product (listed in section 6).
in the eyes, in the nose, or around intravenous cannulas (intravenous therapy).
Do not use the product if any of the above conditions apply to you. If you have any doubts, do not use this
medicinal product. Consult your doctor or pharmacist before using MUPIDER.
Warnings and precautions
Consult your doctor or pharmacist before using MUPIDER.
MUPIDER may cause severe skin reactions or allergies. See “Possible side effects” in
section 4.
Oral thrush (a fungal infection) may occur if MUPIDER is used for a prolonged period. In such a case,
inform your doctor or pharmacist.
Keep the ointment away from the eyes. In case of accidental contact with the eyes, rinse the eyes thoroughly with water.
Children
Do not use MUPIDER in newborns and infants under 8 weeks of age.
Other medicines and MUPIDER
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, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor before using this medicinal product.
If treatment involves a cracked nipple, the ointment must be carefully washed off before breastfeeding.
Driving and operating machinery
MUPIDER has no effect on the ability to drive vehicles or operate machinery.
MUPIDER contains polyethylene glycol
Consult your doctor before using this medicinal product if:
you have kidney problems
you have extensive open wounds or large areas of damaged skin to treat
MUPIDER contains butylated hydroxytoluene (E 321)
Butylated hydroxytoluene may cause localized skin irritation (e.g. contact dermatitis) and irritation of the eyes and mucous membranes.

3. How to use MUPIDER

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
How to use the medicine
Do not mix MUPIDER with other creams or ointments for topical use on the infected skin area, as
this may reduce the effectiveness of MUPIDER.
MUPIDER is generally applied to the skin two to three times a day.

Wash and dry your hands before opening the tube.
Apply the ointment to the infected skin area.
The treated area may be covered with suitable plasters or dressings, unless your doctor has advised you not to cover it.
Close the tube with the cap and wash your hands.
How long to use MUPIDER?
Use MUPIDER for the duration prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Bacteria are usually eliminated from the skin within 10 days of starting treatment.
Do not use for more than 10 days.
Discard any remaining ointment.
If you use more MUPIDER than you should

If you use more MUPIDER than recommended, consult your doctor or pharmacist.
Remove excess ointment with a clean cotton ball or clean gauze.
If MUPIDER has been ingested, seek immediate medical advice and inform the doctor what and how much has been ingested.
If you forget to use MUPIDER
If you forget to apply MUPIDER, do so as soon as you remember. If the next dose is due in less than one hour, skip the missed dose. Do not apply a double dose to make up for a forgotten dose.
If you stop using MUPIDER
If you stop using MUPIDER prematurely, it is possible that not all bacteria have been killed or that they continue to multiply. Ask your doctor or pharmacist when you can stop using the ointment.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Problems to be aware of
Severe skin reactions or allergies
These are very rare in people using MUPIDER. Signs include:
raised, itchy rash
swelling, sometimes of the face or mouth, causing difficulty in breathing
collapse or loss of consciousness.
→ Contact a doctor immediately if any of these symptoms occur. Stop using MUPIDER.
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 may cause inflammation of the colon (large intestine), leading to 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:
Common (may affect up to 1 in 10 people)
Burning sensation at the site of ointment application.

Uncommon (may affect up to 1 in 100 people)
Itching, redness, stinging pain, and dry skin at the site of MUPIDER application.
Allergic skin rash, itching, redness, or skin irritation may also occur in other parts of the body.

Very rare (may affect up to 1 in 10,000 people)
Swelling of the face and/or difficulty in breathing. This may be a sign of a severe allergic reaction that could require emergency treatment.

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 the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store MUPIDER

Keep this medicine out of the sight and reach of children.
Do not store above 25 °C.
Do not use this medicine after the expiry date stated on the tube and carton after "Exp.". The expiry date refers to the last day of that month.
After opening, store the tube below 25 °C. After first opening, the contents may be used for a maximum of 10 days.
MUPIDER is a white, slightly yellowish homogeneous ointment.
Do not use MUPIDER 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 contains

The active substance is mupirocin. 1 g of ointment contains 20 mg of mupirocin.
The other ingredients are macrogol 400 (polyethylene glycol 400) and macrogol 3350 (polyethylene glycol 3350) with butylhydroxytoluene (E 321).

Description of the appearance of MUPIDER and package contents

MUPIDER is a homogeneous, whitish ointment.
MUPIDER is available in 5 g or 15 g aluminium tubes with a membrane, internally coated with epoxy-phenolic lacquer, closed with a polypropylene screw cap with a piercing device. Each tube is packaged in a box.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
INFECTOPHARM Arzneimittel und Consilium GmbH
Von-Humboldt-Str. 1
64646 Heppenheim
Germany
Selling Concessionaire
InfectoPharm S.r.l.
Via Gustavo Fara, 28
20124 Milan, Italy
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Italy: MUPIDER
Poland: SOLTOPIN