Package leaflet: Information for the user

SOLTOPIN, 20 mg/g, 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 or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may
harm someone else, even if their symptoms are the same.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or
pharmacist. See section 4.
Contents of the leaflet

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

1. What SOLTOPIN is and what it is used for

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

infected hair follicles causing pus-filled lumps (‘folliculitis’),
an infectious skin condition with blisters and crusts called ‘impetigo’, or
recurrent boils (‘furunculosis’). to kill various bacteria causing other skin infections, including Staphylococcus, Streptococcus, and Escherichia coli bacteria. This group includes MRSA (methicillin-resistant Staphylococcus aureus strains).

2. Information before using SOLTOPIN

When not to use SOLTOPIN:
if the patient is allergic (hypersensitive) to mupirocin or to any of the other
ingredients of this medicine (listed in section 6).
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into eyes, nose or around intravenous cannula sites (drips).
Do not use in any of the situations listed above. If in doubt, do not use this medicine. Before starting to use SOLTOPIN,
discuss this with your doctor or pharmacist.
Warnings and precautions
Before starting to use SOLTOPIN, discuss this with your doctor or pharmacist.
SOLTOPIN may cause severe skin reactions or allergies. See "Conditions to be aware of" in section 4.
Prolonged use of SOLTOPIN may lead to fungal infection (candidiasis). If this occurs, inform your doctor or pharmacist.
Avoid contact of the ointment with the eyes. If the ointment accidentally gets into the eyes, rinse them thoroughly with water.
Children
Do not use SOLTOPIN in newborns and infants under 8 weeks of age.
SOLTOPIN with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, 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 her doctor before using this medicine.
If treating a cracked nipple, wash the ointment off thoroughly before breastfeeding.
Driving and operating machinery
SOLTOPIN has no influence on the ability to drive and operate machinery.
SOLTOPIN contains polyethylene glycol
Before starting to use this medicine, discuss this with your doctor if:
the patient has kidney disease
the surface area of treated open wounds or damaged skin is large.
SOLTOPIN contains butylhydroxytoluene (E 321)
Butylhydroxytoluene may cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes.

3. How to use SOLTOPIN

This medicine should always be used exactly as directed by your doctor or pharmacist. If you are unsure,
consult your doctor or pharmacist.
How to use this medicine
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Do not mix SOLTOPIN with any other topical cream or ointment applied to the infected area of skin, as this may reduce the effectiveness of SOLTOPIN.
SOLTOPIN is usually applied to the skin 2–3 times daily.

Wash and dry your hands before opening the tube.
Apply the ointment to the infected area of skin.
The treated area may be covered with a plaster (plasters) or appropriate dressing (dressings), unless your doctor has advised leaving it uncovered.
Replace the cap on the tube and wash your hands.
How long should SOLTOPIN be used?
SOLTOPIN should be used for as long as directed by your doctor. If in doubt, consult your doctor or pharmacist. Bacteria are usually cleared from the skin within 10 days of starting treatment.
Do not use for longer than 10 days. Any unused ointment should be discarded.
Use of more than the recommended dose of SOLTOPIN

If more than the recommended dose of SOLTOPIN has been used, consult your doctor or pharmacist.
Excess ointment should be removed with a clean swab or gauze pad.
If SOLTOPIN has been swallowed, contact your doctor immediately and inform them what and how much has been ingested.
Missed dose of SOLTOPIN
If you forget to apply SOLTOPIN, apply it as soon as you remember. If the next dose is due within the next hour, do not apply the missed dose. Do not apply a double dose to make up for a missed dose.
Stopping SOLTOPIN treatment
If SOLTOPIN treatment is stopped too early, not all bacteria may be killed or they may continue to grow. Consult your doctor or pharmacist about when to stop using the ointment.

If you have any further questions 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 not everybody will experience them.
Conditions to be aware of
Severe skin reactions or allergies
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These are very rare in people using SOLTOPIN. Symptoms include:

raised, itchy rash
swelling, sometimes of the face or lips, causing difficulty in breathing
collapse or loss of consciousness → Contact a doctor immediately if any of the above symptoms occur. Discontinue use of SOLTOPIN.

In case of a severe skin or allergic reaction:

wash off the ointment
discontinue its use, and
contact a doctor as soon as possible.

In rare cases, medicines such as SOLTOPIN may cause inflammation of the colon (large intestine), leading to diarrhoea, usually bloody and containing mucus, abdominal pain, and fever (pseudomembranous colitis).
→ Contact a doctor as soon as possible if any of these symptoms occur.

The following adverse reactions may occur during treatment with this medicine:
Common (may occur in up to 1 in 10 people)
Burning sensation at the site of ointment application.
Uncommon (may occur in up to 1 in 100 people)
Itching, redness, stinging, and dryness of the skin at the site of SOLTOPIN application.
Allergic rash, itching, redness, or skin pain may also occur in other parts of the body.
Very rare (may occur in up to 1 in 10,000 people)
Facial swelling and/or difficulty breathing. This may be a sign of a severe allergic reaction, which may require emergency treatment.
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 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.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.
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5. How to store SOLTOPIN

Keep this medicine out of 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 the stated month.
After opening, store the tube below 25 °C.
Period of use after first opening of the immediate packaging: 10 days.
SOLTOPIN is a uniform, whitish ointment.
Do not use SOLTOPIN if it appears different from normal.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What Soltopin contains

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

What Soltopin looks like and contents of the pack

Soltopin is a homogeneous, white to off-white ointment.
Soltopin is available in aluminium tubes containing 5 g or 15 g of ointment, with a membrane, internally coated with epoxy-phenolic lacquer, closed with a polypropylene cap with a piercing device, placed in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
INFECTOPHARM Arzneimittel und Consilium GmbH
Von-Humboldt-Str. 1
D-64646 Heppenheim
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:
Poland: SOLTOPIN
Italy: MUPIDER
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