PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Nifux 2 mg/g ointment
Nitrofuralum
Please read carefully the entire leaflet before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
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 you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If your condition does not improve or if you feel worse, consult your doctor.
If there is no improvement within 5–7 days, or if you feel worse, consult your doctor.

Table of contents of the leaflet

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

1. What Nifux is and what it is used for

Nifux is an ointment intended for topical application to the skin. The active substance is nitrofural, which has antibacterial properties. Its mechanism of action involves inhibition of bacterial enzymes.
Indications
Bacterial skin infections (caused by Staphylococcus aureus, Streptococcus pyogenes, Escherichia coli, Aerobacter aerogenes, and Proteus species). Secondary infections of allergic skin lesions caused by these bacteria.
As an adjunct in the treatment of burns and ulcers.
As an adjunct in the prevention of infections in wounds and skin grafts.

2. Important information before using Nifux

When not to use Nifux

if the patient is allergic to nitrofurazone or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
If symptoms such as irritation, rash, or local swelling occur, discontinue use of the medicine and contact a doctor.
Children and adolescents
Do not use in children and adolescents. There is a lack of data regarding the use of Nifux in children and adolescents.
Nifux 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 use.
There are no studies on interactions with other medicines.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
Nifux may be used in pregnant women and during breastfeeding only when deemed necessary by a physician.
There is lack of data on the safety of using this medicine during pregnancy and breastfeeding.
Driving and operating machinery
Nifux has no effect on the ability to drive or operate machinery.

3. How to use Nifux

This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Dosage
Affected skin areas should be covered with a thin layer of the medicine once or twice daily.
Nifux should not be used without medical advice for longer than 5 to 7 days.
Method of administration
The medicine is intended for topical use on the skin.
The simultaneous use of a sterile dressing is recommended.
Use in children and adolescents
Do not use in children and adolescents. There is a lack of data regarding the use of Nifux in children and adolescents.
Use of a higher than recommended dose of Nifux
No data available.
Systemic adverse effects following an overdose are unlikely, since nitrofurazone is absorbed to a negligible extent through intact skin, burned skin, and mucous membranes.
Missed dose of Nifux
Do not apply a double dose to make up for a missed dose.
Stopping treatment with Nifux
If you have any further doubts concerning the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, Nifux can cause adverse reactions, although not everybody experiences them.
Usually, adverse reactions affecting the skin and subcutaneous tissue occur:
Common (occur in 1 to 10 out of 100 patients):
allergic reaction (so-called contact dermatitis), manifested by itching, irritation,
swelling, and skin pruritus.
Uncommon (occur in 1 to 10 out of 1,000 patients):
allergic dermatitis.
If such symptoms occur, treatment should be discontinued and a doctor should be consulted.
Reporting of adverse reactions
If any adverse symptoms 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 of the Office for Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, phone: 22 49 21 301, fax: 22 49 21 309, e-mail: [email protected].
Adverse reactions can also be reported to the marketing authorization holder.
By reporting adverse reactions, additional information on the safety of using the medicine can be collected.

5. How to store Nifux

Keep the medicine out of the sight and reach of children.
Store below 25°C. Store in the original packaging.
Keep the tube tightly closed.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the stated month.
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 package and other information

What the medicine Nifux contains

The active substance is nitrofural.
1 g of ointment contains 2 mg of nitrofural.
The other ingredient of the medicine is white petroleum jelly.

What Nifux looks like and contents of the pack
Nifux is a yellow to light yellow ointment with a uniform consistency.
The medicine is available in an aluminum tube containing 25 g of ointment, placed in a cardboard box.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
OCEANIC Joint Stock Company
Łokietka 58 Street
81-736 Sopot

Manufacturer:
OCEANIC Joint Stock Company
Gdańska 5 Street
Trąbki Małe
83-034 Trąbki Wielkie

For further information, please contact the Marketing Authorisation Holder's representative:
OCEANIC Joint Stock Company, Gdańska 5 Street, Trąbki Małe, 83-034 Trąbki Wielkie, tel. 58 692 10 00