PSEROCINA 20 mg /G Maść

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1. PSEROCINA 20 mg/g ointment
   1. What is PSEROCINA and what is it used for
   2. What you need to know before using PSEROCINA
   3. How to use PSEROCINA
   4. Possible side effects
   5. How to store PSEROCINA
   6. Contents of the pack and other information

PSEROCINA 20 mg/g ointment

mupirocin
Generic medicine
Read this leaflet carefully before using this medicine as 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 pass it on to others, even if they have the same
symptoms as you, as it may be harmful.
If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What PSEROCINA is and what it is used for
• 2. What you need to know before you use PSEROCINA
• 3. How to use PSEROCINA
• 4. Possible side effects
• 5. How to store PSEROCINA
• 6. Contents of the pack and other information

1. What is PSEROCINA and what is it used for

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

• infection of hair follicles with the formation of pustules containing pus (“folliculitis”),
• a contagious skin infection with blisters and scabs, called “impetigo”, or
• recurring boils (“furunculosis”). to kill various bacteria that cause other skin infections, such as Staphylococci,Streptococciand E. coli. This group includes MRSA bacteria (methicillin-resistant Staphylococcus aureus).

2. What you need to know before using PSEROCINA

Do not use PSEROCINA
if you are allergic (hypersensitive) to mupirocin or any of the other ingredients of this
medicine (listed in section 6).
in the eyes, in the nose or around intravenous cannulas (intravenous therapy).
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Do not use the product if any of the above conditions apply to you. If you have doubts, do not use this
medicine. Ask your doctor or pharmacist before using PSEROCINA.

Warnings and precautions
Talk to your doctor or pharmacist before using PSEROCINA.
PSEROCINA may cause severe skin reactions or allergies. See “Things to be careful about”
in section 4.
Thrush (a fungal infection) may occur if you use PSEROCINA for a long time. In this
case, inform your doctor or pharmacist.
Keep the ointment away from your eyes. If accidental contact with the eyes occurs, wash your eyes
thoroughly with water.

Children
Do not use PSEROCINA in newborns and infants under 8 weeks of age.

Other medicines and PSEROCINA
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor for advice before using this medicine.
If the treatment concerns a cracked nipple, the ointment must be washed off carefully before
breastfeeding.

Driving and using machines
PSEROCINA has no effect on the ability to drive vehicles or use machines.

PSEROCINA contains polyethylene glycol
Talk to your doctor before using this medicine if:
you have kidney problems
you have extensive open wounds or large areas of damaged skin to be treated

PSEROCINA contains butylhydroxytoluene (E 321)
Butylhydroxytoluene may cause local, limited skin irritation (e.g. contact dermatitis) and irritation of the eyes and mucous membranes.

3. How to use PSEROCINA

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have any
doubts, consult your doctor or pharmacist.

How to use the medicine
Do not mix PSEROCINA with other creams or ointments for external use on the infected skin area,
because this may reduce the effectiveness of PSEROCINA.
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Generally, apply PSEROCINA to the skin 2 to 3 times a day.
1 .Wash and dry your hands before opening the tube.
2 .Apply the ointment to the infected skin area.
3 .The treated area may be covered with plasters or suitable bandages, unless your doctor has
told you not to cover it.
4 .Close the tube with the cap and wash your hands.

For how long to use PSEROCINA?
Use PSEROCINA for the entire time indicated by your doctor. If you have any doubts, consult your doctor or
pharmacist. Bacteria are normally 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 PSEROCINA than you should

• If you use more PSEROCINA than you should, ask your doctor or pharmacist for advice.
• Remove the excess ointment with a clean cotton ball or clean gauze.
• In case of ingestion of PSEROCINA, seek immediate medical attention and report what you have ingested and in what quantity. If you forget to use PSEROCINAIf you forget to apply PSEROCINA, apply it as soon as you remember. If the next dose is due in less than an hour, skip the missed dose. Do not use a double dose to make up for a missed dose. If you stop using PSEROCINAIf you stop using PSEROCINA early, 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 the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Problems to watch out for
Severe skin reactions or allergies
These are very rare in people who use PSEROCINA. The signs include:
raised and itchy rash
swelling, sometimes of the face or mouth, causing difficulty in breathing
collapse or loss of consciousness.

• Contact a doctor immediatelyif any of these symptoms occur. Stop using PSEROCINA.

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If you develop a severe skin reaction or an allergy:
wash off the ointment
stop using it and
tell your doctor as soon as possible.
In rare cases, medicines like PSEROCINA can cause inflammation of the colon (large
intestine), causing diarrhoea, usually with blood and mucus, stomach pain, fever (pseudomembranous
colitis).

• Tell your doctor as soon as possibleif 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 at the site of ointment application.

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

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

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through 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 PSEROCINA

Keep this medicine out of the sight and reach of children.
Do not store at a temperature above 25 °C.
Do not use this medicine after the expiry date which is stated on the tube and the carton after
“Exp.”. The expiry date refers to the last day of that month.
After opening, store the tube at a temperature below 25 ºC. After first opening, the
contents can be used for a maximum of 10 days.
PSEROCINA is a homogeneous, off-white ointment.
Do not use PSEROCINA if it has a different appearance than normal.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

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What PSEROCINA contains

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

Description of the appearance of PSEROCINA and contents of the pack

• PSEROCINA is a homogeneous, whitish ointment.
• PSEROCINA is available in aluminum tubes of 5 g or 15 g with a membrane, coated inside with epoxy-phenolic lacquer, closed with a screw cap made of polypropylene with a tamper-evident seal. Each tube is packaged in a carton.
• Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
INFECTOPHARM Arzneimittel und Consilium GmbH
Von-Humboldt-Str. 1
64646 Heppenheim
Germany

Distributor
FARMA GROUP S.r.l.
Via N. Strampelli, 18
63074 San Benedetto del Tronto (AP)

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Italy: PSEROCINA
Poland: Mupirocin InfectoPharm
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