Package leaflet: Information for the user

Nitrofurazon
2 mg/g, ointment
(Nitrofuralum)
Please read all of this leaflet carefully before using this medicine, because it contains
information important for the patient.
This medicine should always be used exactly as described in the patient leaflet or according to
the instructions of a doctor or pharmacist.

Keep this leaflet, so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 5–7 days, or if the patient feels worse, consult a doctor.

Contents of the leaflet:

What Nitrofurazon is and what it is used for
Important information before using Nitrofurazon
How to use Nitrofurazon
Possible side effects
How to store Nitrofurazon
Contents of the pack and other information

1. What Nitrofurazon is and what it is used for

Nitrofurazon is an ointment for topical application to the skin. It contains the active substance nitrofural, which has antibacterial properties.
Indications for Nitrofurazon:

bacterial skin infections (caused by bacteria: Staphylococcus aureus, Streptococcus pyogenes, Escherichia coli, Proteus sp., Aerobacter aerogenes);
secondary bacterial infections of allergic skin lesions;
adjunctive treatment of burns and ulcers;
adjunctive prevention of infections in wounds and skin grafts.

2. Important information before using Nitrofurazon

When not to use Nitrofurazon
Do not use this medicine if the patient is allergic to nitrofural or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
If any signs of hypersensitivity (such as irritation, rash or local swelling) occur at the site of application, discontinue use of the medicine and consult a doctor or pharmacist.

Children
Do not use in children under 12 years of age due to lack of data on the use of this medicine in this patient group.

Nitrofurazon and 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 take.

No interaction has been observed between Nitrofurazon and other medicines applied locally to the skin.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Nitrofurazon may be used in pregnant and breastfeeding women only if deemed necessary by a physician.
There is lack of data regarding the safety of using this medicine during pregnancy and breastfeeding.

Driving and operating machinery
Nitrofurazon has no known influence on the ability to drive and operate machinery or on psycho-physical performance.

3. How to use Nitrofurazon

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
The medicine is intended for topical application to the skin.
Recommended dosage
Apply once or twice daily.
A thin layer of the ointment should be applied to the affected areas of the skin. If necessary, these areas may be covered with a sterile dressing.
If there is no improvement after 5–7 days, or if the patient's condition worsens, consult a doctor.
Use in children
Do not use in children under 12 years of age.
Use of a higher than recommended dose of Nitrofurazon
If more than the recommended dose is used, consult a doctor.
The risk of overdose with this medicine is low.
Missed dose of Nitrofurazon
Apply the ointment as soon as possible, and then apply the next dose at the usual time.
Do not apply a double dose to make up for a missed dose.
If you have any further doubts regarding 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 everyone will experience them.
Not common (occurs more frequently than in 1 out of 1,000 but less frequently than in 1 out of 100 patients) adverse reactions may include skin and subcutaneous tissue disorders:

allergic reaction (so-called contact dermatitis) manifested by itching, irritation, and swelling
allergic dermatitis manifested by redness, dryness, and itching of the skin

If such symptoms occur, treatment should be discontinued and medical advice should be sought.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse.
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
Phone: +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.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Nitrofurazon

Keep this medicine out of sight and reach of children. Store at a temperature below 25°C. Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Nitrofurazon medicine may be used for up to 6 months after the date of first use of the medicine, provided that this does not exceed the expiry date indicated on the packaging.
Enter the date of first use of the medicine in this box:
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the package and other information

What Nitrofurazon contains

The active substance is nitrofural. 1 g of ointment contains 2 mg of nitrofural.
The other ingredient is: white petrolatum.

What Nitrofurazon looks like and contents of the pack
The medicine is a yellow ointment. Packaging: an internally lacquered aluminum tube with a PE cap,
containing 25 g of ointment, placed in a cardboard box with a leaflet.
Marketing Authorisation Holder and Manufacturer
Pharmaceutical Plants "UNIA" Labour Cooperative
Chłodna 56/60, 00-872 Warsaw
tel.: 22 620 90 81 ext. 190, fax: 22 654 92 40
e-mail: [email protected]
The Nitrofurazon package leaflet is available in the Audio Leaflet system via the nationwide,
toll-free telephone number: 800 706 848.