Nitrofurazon

1. What is Nitrofurazon and what is it used for

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

Indications for use of Nitrofurazon:

• bacterial skin infections (caused by bacteria: Staphylococcus aureus, Streptococcus pyogenes, Escherichia coli, Proteus sp., Aerobacter aerogenes);
• secondary infections of allergic lesions caused by bacteria;
• supportive treatment of burns and ulcers;
• supportive prevention of wound and skin graft infections.

2. Important information before using Nitrofurazon

When not to use Nitrofurazon

The medicine should not be used if the patient is allergic to nitrofural or any other component of the 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, the use of the medicine should be discontinued and a doctor or pharmacist consulted.

Children

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

Nitrofurazon and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
No interaction between Nitrofurazon and other locally applied skin medicines has been found.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.
Nitrofurazon may be used in pregnant and breastfeeding women only if the doctor considers it necessary.
There is no data on the safety of using this medicine during pregnancy and breastfeeding.

Driving and operating machinery

No effect of the medicine on the ability to drive and operate machinery, as well as on psychophysical fitness, has been found.

3. How to use Nitrofurazon

This medicine should always be used exactly as described in the patient leaflet or according to the doctor's or pharmacist's instructions.
In case of doubts, consult a doctor or pharmacist.
The medicine is intended for topical application to the skin.

Recommended dosage

Apply 1 or 2 times a day.
A thin layer of ointment should be applied to the affected areas of the skin. If necessary, they can be covered with a sterile dressing.
If after 5-7 days there is no improvement or the patient feels worse, consult a doctor.

Use in children

Do not use in children under 12 years of age.

Using more than the recommended dose of Nitrofurazon

In case of using more than the recommended dose of the medicine, consult a doctor.
The risk of overdose of this medicine is low.

Missing a dose of Nitrofurazon

Apply the ointment as soon as possible, and the next dose at the usual time.
Do not use a double dose to make up for a missed dose.
In case of any further doubts about using this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Uncommon(more than 1 in 1,000, but less than 1 in 100 patients) side effects may include skin and subcutaneous tissue disorders:

• allergic reaction (contact dermatitis) with symptoms of itching, irritation, swelling
• allergic skin inflammation with symptoms of redness, dryness, and itching of the skin

If such symptoms occur, discontinue treatment and consult a doctor.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, tell your doctor or pharmacist or nurse.
Side effects can be reported directly to the Department of Monitoring 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 gather more information on the safety of the medicine.

5. How to store Nitrofurazon

Keep the medicine out of the sight and reach of children. Store in 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 month stated.
Nitrofurazon can be used for 6 months from the date of first use, without exceeding the expiry date stated on the packaging.
Write the date of first use in this window:
Medicines should not be disposed of via wastewater or household waste containers. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Nitrofurazon contains

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

What Nitrofurazon looks like and what the package contains

The medicine is a yellow ointment. The package: an aluminum tube internally lacquered with a PE screw cap, containing 25 g of ointment, placed in a cardboard box with a leaflet.

Marketing authorization holder and manufacturer

Zakłady Farmaceutyczne „UNIA” Spółdzielnia Pracy
ul. Chłodna 56/60, 00-872 Warsaw
tel.: 22 620 90 81 ext. 190, fax: 22 654 92 40
e-mail: [email protected]
The content of the Nitrofurazon leaflet is available in the Ulotka Audio system at the national, free phone number: 800 706 848.
Date of last update of the leaflet:June 2021