Nifuroksazid Polfarmex

Package Leaflet: Information for the User

NIFUROKSAZYD POLFARMEX, 200 mg, film-coated tablets

Nifuroxazidum

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this package leaflet for the patient, or as directed by a doctor or pharmacist.

• This package leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the package leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse after 3 days, they should contact their doctor.

Package Leaflet Contents

• 1. What is Nifuroksazyd Polfarmex and what is it used for
• 2. Important information before taking Nifuroksazyd Polfarmex
• 3. How to take Nifuroksazyd Polfarmex
• 4. Possible side effects
• 5. How to store Nifuroksazyd Polfarmex
• 6. Package contents and other information

1. What is Nifuroksazyd Polfarmex and what is it used for

Nifuroksazyd Polfarmex is a 5-nitrofuran derivative and an antibacterial agent. It exhibits local action in the intestinal lumen against certain species of bacteria.
Nifuroksazyd Polfarmex does not destroy non-pathogenic bacteria that normally occur in the gastrointestinal tract. It does not cause the development of bacterial strains resistant to its action.
After oral administration, the product is partially absorbed (10-20%) from the gastrointestinal tract and is extensively metabolized, with the main circulating compounds in the blood being metabolites.
Nifuroksazyd Polfarmex is used in acute and chronic bacterial diarrhea in adults and children over 7 years old.

2. Important information before taking Nifuroksazyd Polfarmex

When not to take Nifuroksazyd Polfarmex

• If the patient is allergic to nifuroxazide, 5-nitrofuran derivatives, or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may manifest as a rash, swelling of the face, lips, tongue, or difficulty breathing, confusion, pallor, rapid breathing, weakness, and fainting (if such symptoms occur, a doctor should be consulted immediately).
• It should not be used in children under 7 years old, as children of this age may have difficulty swallowing the tablet.

Warnings and precautions

• If diarrhea persists after 2 or 3 days of treatment or worsens during treatment, a doctor should be consulted immediately.
• In the event of an allergic reaction with symptoms such as rash, itching, swelling, confusion, pallor, rapid breathing, weakness, and fainting, the use of Nifuroksazyd Polfarmex should be discontinued.
• It is necessary to drink plenty of fluids, sweet or salty, to replenish lost fluids due to diarrhea (average water requirement for an adult is 2 liters).
• It is recommended to continue eating during the entire duration of diarrhea:
• excluding certain food products - in particular raw vegetables, fruits, green vegetables, spicy dishes, as well as frozen food and cold drinks;
• grilled meat and rice are preferred;
• alcohol should not be consumed during treatment with nifuroxazide.
• As a precautionary measure, Nifuroksazyd Polfarmex should not be administered during pregnancy and breastfeeding.

In the event of severe and prolonged diarrhea, severe vomiting, or loss of appetite, a doctor should be consulted, as intravenous hydration may be necessary.
Before starting treatment with Nifuroksazyd Polfarmex, it should be discussed with a doctor or pharmacist.

Nifuroksazyd Polfarmex and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Nifuroksazyd Polfarmex reduces the absorption of many medicines from the gastrointestinal tract. Therefore, during treatment with Nifuroksazyd Polfarmex, other oral medicines should not be taken at the same time.

Taking Nifuroksazyd Polfarmex with food, drink, and alcohol

See "Warnings and precautions" and section 3.
Consuming alcohol during treatment with Nifuroksazyd Polfarmex may cause acute and severe intolerance reactions (so-called disulfiram-like reactions).

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medicine. As a precautionary measure, Nifuroksazyd Polfarmex should not be administered during pregnancy and breastfeeding. In women of childbearing age, Nifuroksazyd Polfarmex can be used only if they are using effective contraception.

Driving and operating machinery

Nifuroksazyd Polfarmex does not affect the ability to drive and operate machinery.

Nifuroksazyd Polfarmex contains 3.84 mg of lactose monohydrate in one film-coated tablet

If the patient has previously been diagnosed with intolerance to certain sugars, they should consult a doctor before taking the medicine. The medicine contains 0.00384 g of lactose (0.00192 g of glucose and 0.00192 g of galactose) in one film-coated tablet. This should be taken into account in patients with diabetes.

3. How to take Nifuroksazyd Polfarmex

This medicine should always be taken exactly as described in this package leaflet for the patient, or as directed by a doctor or pharmacist. If there are any doubts, a doctor or pharmacist should be consulted.
The recommended dose is:
Adults:800 mg per day in 2-4 divided doses.
Children over 7 years old:600-800 mg per day in 2-4 divided doses.
Nifuroksazyd Polfarmex should not be taken for more than 3 days without consulting a doctor. If symptoms worsen or do not improve after 3 days, a doctor should be consulted. The medicine should not be taken for more than 7 days.
The medicine is taken orally. The tablets should be swallowed whole, washed down with a sufficient amount of liquid (a glass of water). The tablets should not be chewed or crushed.
Nifuroksazyd Polfarmex should not be taken for more than 3 days without consulting a doctor.
If symptoms worsen or do not improve after 3 days, a doctor should be consulted.
During treatment for diarrhea with Nifuroksazyd Polfarmex, it is necessary to replenish fluids (see "Warnings and precautions" in section 2).

Taking a higher dose of Nifuroksazyd Polfarmex than recommended

In the event of taking a higher dose of the medicine than recommended, a doctor or pharmacist should be consulted immediately. The doctor should be shown the packaging with the tablets.

Missing a dose of Nifuroksazyd Polfarmex

If a dose is missed, it should be taken as soon as possible, unless it is almost time for the next dose.
A double dose should not be taken to make up for a missed dose.

Stopping treatment with Nifuroksazyd Polfarmex

Treatment should not be stopped before 3 days have passed, even if the patient feels better.
If there are any further doubts about taking this medicine, a doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, Nifuroksazyd Polfarmex can cause side effects, although not everybody gets them.
A doctor should be consulted immediately if an allergic reaction occurs:

• allergic reactions, e.g., skin reactions; rash, urticaria, angioedema (manifested as swelling of the face, lips, tongue, or difficulty breathing);
• anaphylactic shock (manifested as confusion, pallor, rapid breathing, weakness, and fainting).

The following side effects may also occur:
rare (less than 1 in 1000 patients):
rash;
skin pustules.
unknown (frequency cannot be estimated from available data):
granulocytopenia (reduced number of a certain type of white blood cell - granulocytes);
nodular prurigo in contact allergy to nifuroxazide;
abdominal pain;
nausea;
worsening of diarrhea.
If mild abdominal pain, nausea, and diarrhea occur, there is no need for special treatment or discontinuation of nifuroxazide. If the symptoms are severe, the medicine should be discontinued. In such cases, nitrofuran derivatives should be avoided in the future.

Reporting side effects

If any side effects occur, including any side effects not listed in the package leaflet, a doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: (22) 49 21 301
Fax: (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 Nifuroksazyd Polfarmex

The medicine should be stored out of sight and reach of children.
It should be stored at a temperature below 25°C.
The medicine should not be used after the expiration date stated on the packaging and blister after: "EXP". The expiration date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. A pharmacist should be asked how to dispose of unused medicines. This will help protect the environment.

6. Package contents and other information

What Nifuroksazyd Polfarmex contains

The active substance of the medicine is nifuroxazide (Nifuroxazidum).
One film-coated tablet contains 200 mg of nifuroxazide.
The other ingredients are: potato starch, povidone K-25, magnesium stearate.
Coating: lactose monohydrate, hypromellose 6cP, titanium dioxide (E 171), macrogol 6000, yellow iron oxide (E 172).

What Nifuroksazyd Polfarmex looks like and what the package contains

Nifuroksazyd Polfarmex - film-coated tablet, yellow, round, biconvex, with a nominal diameter of 10 mm, without spots and damage.
The package contains 20 or 30 film-coated tablets.

Marketing authorization holder and manufacturer

Polfarmex S.A.
ul. Józefów 9
99-300 Kutno
Poland (Poland)
Phone: 24 357 44 44
Fax: 24 357 45 45
e-mail: polfarmex@polfarmex.pl

Date of last revision of the package leaflet: