Soltopin

Package Leaflet: Information for the User

SOLTOPIN, 20 mg/g, ointment

Mupirocin

Please read carefully the contents of this leaflet before using the medicine, as it contains

important information for the patient.
Keep this leaflet, you may need to read it again.
In case of any doubts, consult a doctor or pharmacist.
This medicine has been prescribed to you by a doctor. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is SOLTOPIN and what is it used for

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

• infected hair follicles, forming lumps containing pus (“folliculitis”),
• infectious skin disease with blisters and crusts, called “impetigo” or
• recurring boils (“furunculosis”). to kill various bacteria that cause other skin infections, including those from the genus Staphylococcus, Streptococcusand bacteria Escherichia coli. This group includes MRSA (methicillin-resistant Staphylococcus aureus).

2. Important information before using SOLTOPIN

When not to use SOLTOPIN:

if you are allergic (hypersensitive) to mupirocin or any of the other ingredients of this medicine (listed in section 6).
in the eyes, nose, or in areas around the insertion of intravenous cannulas (“drips”).
Do not use in case of any of the above situations. In case of doubt, do not use this medicine. Before using SOLTOPIN, discuss it with your doctor or pharmacist.

Warnings and precautions

Before using SOLTOPIN, discuss it with your doctor or pharmacist.
SOLTOPIN may cause severe skin reactions or allergies. See “Conditions to watch out for” in section 4.
Prolonged use of SOLTOPIN may lead to thrush (fungal infection). If this occurs, tell 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 and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about medicines you plan to take.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before using this medicine.
If you are being treated for a cracked nipple, wash the ointment off thoroughly before breastfeeding.

Driving and using machines

SOLTOPIN has no effect on the ability to drive and use machines.

SOLTOPIN contains polyethylene glycol

Before using this medicine, discuss it with your doctor if:
you have kidney disease
the surface area of treated open wounds or damaged skin is large.

SOLTOPIN contains butylhydroxytoluene (E 321)

Butylhydroxytoluene may cause local skin reaction (e.g., contact dermatitis) or eye and mucous membrane irritation.

3. How to use SOLTOPIN

This medicine should always be used as directed by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.

Using this medicine

Do not mix SOLTOPIN with any other external medicine in the form of cream or ointment on the infected skin area, as this may reduce the effectiveness of SOLTOPIN.
SOLTOPIN is usually applied to the skin 2-3 times a day.
1 .Before opening the tube, wash and dry your hands.
2 .Apply the ointment to the infected skin area.
3 .The treated skin area can be covered with a plaster (plasters) or a suitable dressing (dressings), unless the doctor has advised against it.
4 .Put the cap back on the tube and wash your hands.

How long to use SOLTOPIN?

Use SOLTOPIN for as long as your doctor has told you. In case of doubt, consult your doctor or pharmacist. Bacteria are usually removed from the skin within 10 days of starting treatment.
Do not use for more than 10 days. Dispose of any unused ointment.

Using more than the recommended dose of SOLTOPIN

• In case of using more than the recommended dose of SOLTOPIN, consult your doctor or pharmacist.
• Remove excess ointment with a clean cotton swab or gauze.
• In case of swallowing SOLTOPIN, contact your doctor immediately and tell them what and how much was swallowed.

Missing a dose of SOLTOPIN

In case of missing a dose of SOLTOPIN, use it as soon as you remember.
If the next dose is to be used within the next hour, do not use the missed dose.
Do not use a double dose to make up for the missed dose.

Stopping the use of SOLTOPIN

In case of stopping the use of SOLTOPIN too early, not all bacteria may be killed or may continue to grow. Consult your doctor or pharmacist when to stop using the ointment.
In case of any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Conditions to watch out for

Severe skin reactions or allergies

These are very rare in people using SOLTOPIN. Symptoms include:

• raised and itchy rash
• swelling, sometimes of the face or lips, causing difficulty breathing
• collapse or loss of consciousness → Seek medical attention immediatelyif any of the above symptoms occur. Stop using SOLTOPIN.

In case of a severe skin reaction or allergy:

• wash off the ointment
• stop using it and
• notify your doctor as soon as possible.

In rare cases, medicines like SOLTOPIN may cause colitis (inflammation of the colon), leading to diarrhea, usually bloody and containing mucus, abdominal pain, fever (pseudomembranous colitis).
→ Notify your doctor as soon as possibleif any of these symptoms occur.
The following side effects may occur during the use of this medicine:
Common(may occur in up to 1 in 10 people)
Burning sensation at the application site.
Uncommon(may occur in up to 1 in 100 people)
Itching, redness, stinging, and dryness of the skin at the application site of SOLTOPIN.
Allergic rash, itching, redness, or skin pain may also occur on other parts of the body.
Rare(may occur in up to 1 in 10,000 people)
Swelling of the face and (or) difficulty breathing. This may be a sign of a severe allergic reaction, which may require emergency treatment.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Adverse Reactions to Medicinal Products of 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.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store SOLTOPIN

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 the month.
After opening the tube, store it below 25 ºC.
Shelf-life after first opening of the immediate packaging: 10 days.
SOLTOPIN is a uniform, white ointment.
Do not use SOLTOPIN if it looks different from normal.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack 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 uniform, white ointment.
• SOLTOPIN is available in aluminum tubes containing 5 g or 15 g of ointment, with a membrane, coated internally with epoxy-phenolic lacquer, closed with a polypropylene cap with a piercer, placed in a cardboard box.
• Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

INFECTOPHARM Arzneimittel und Consilium GmbH
Von-Humboldt-Str. 1
D-64646 Heppenheim
Germany
To obtain more detailed information, please contact the representative of the marketing authorization holder:
SOLPHARM Sp. z o.o.
ul. Zakątek 1
05-270 Marki
Tel.: + 48 22 616 28 08

This medicinal product is authorized in the Member States of the European

Economic Area under the following names:

Poland:
SOLTOPIN
Italy:
PSEROCINA

Date of last revision of the leaflet: 20.04.2022