Nifux

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE PATIENT

Nifux2 mg/g ointment
Nitrofural

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

important information for the patient.
This medicine should always be used exactly as described in the patient information leaflet or as advised by
the doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, the pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, the doctor or pharmacist should be informed. See section 4.
• If there is no improvement or the patient feels worse, the doctor should be contacted.
• If there is no improvement or the patient feels worse within 5-7 days, the doctor should be contacted.

Table of contents of the leaflet

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

1. What is Nifux and what is it used for

Nifux is an ointment intended for use on the skin. The active substance is nitrofural
with antibacterial action. Its mechanism of action involves inhibiting bacterial enzymes.

Indications for use

Bacterial skin infections (with Staphylococcus aureus, Streptococcus pyogenes, Escherichia
coli, Aerobacter aerogenesand Proteusbacteria). Secondary infections of allergic lesions caused by these bacteria.
Supportive treatment of burns and ulcers.
Supportive treatment to prevent wound and skin graft infections.

2. Important information before using Nifux

When not to use Nifux

Warnings and precautions

If symptoms such as irritation, rash, or local swelling occur, the use of the medicine should be stopped and the doctor consulted.

Children and adolescents

Nifux should not be used in children and adolescents. There is no data on the use of Nifux in children and adolescents.

Nifux and other medicines

The doctor or pharmacist should be informed about all medicines currently or recently used by the patient, as well as any planned to be used.
There are no studies on interactions with other medicines.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult the doctor or pharmacist before using this medicine.
Nifux 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 using machines

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

3. How to use Nifux

This medicine should always be used exactly as described in the patient information leaflet or as advised by
the doctor or pharmacist. In case of doubts, the doctor or pharmacist should be consulted.
Dosage
Pathologically changed skin areas should be covered with a thin layer of the medicine once or twice a day. Nifux should not be used without a doctor's recommendation for more than 5 to 7 days.
Method of administration
The medicine is intended for use on the skin.
It is recommended to use a sterile dressing at the same time.

Use in children and adolescents

Nifux should not be used in children and adolescents. There is no data on the use of Nifux in children and adolescents.

Using a higher dose of Nifux than recommended

No data available.
The occurrence of systemic side effects due to overdose of the medicine is unlikely, as nitrofural is absorbed through intact, burned, and mucous membranes to a negligible extent.

Missing a dose of Nifux

A double dose should not be used to make up for a missed dose.

Stopping the use of Nifux

In case of any further doubts about the use of this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, Nifux can cause side effects, although not everybody gets them.
Usually, skin and subcutaneous tissue disorders occur:
Common(occurring in 1 to 10 in 100 patients):
allergic reaction (so-called contact dermatitis), manifested by itching, irritation, swelling, skin redness.
Uncommon(occurring in 1 to 10 in 1000 patients):
allergic skin inflammation.
If such symptoms occur, treatment should be discontinued and the doctor consulted.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor or pharmacist, or nurse should be informed.
Side effects can be reported directly to the Department for 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.: 22 49 21 301, fax: 22 49 21 309, e-mail: ndl@urpl.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 the medicine.

5. How to store Nifux

The medicine should be stored out of sight and reach of children.
Store at a temperature below 25°C. Store in the original packaging.
Store 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 month.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer used. This will help protect the environment.

6. Contents of the packaging and other information

What Nifux contains

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

What Nifux looks like and what the pack contains

Nifux is a light yellow to yellow ointment of uniform consistency.
The available packaging of the medicine is an aluminum tube containing 25 g of ointment, placed in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder:

OCEANIC Spółka Akcyjna
ul. Łokietka 58
81-736 Sopot

Manufacturer:

OCEANIC Spółka Akcyjna
ul. Gdańska 5
Trąbki Małe
83-034 Trąbki Wielkie
To obtain more detailed information, please contact the representative of the marketing authorization holder:
OCEANIC Spółka Akcyjna, ul. Gdańska 5, Trąbki Małe, 83-034 Trąbki Wielkie, tel. 58 692 10 00

Date of last update of the leaflet: