Nifuroksazid Aflofarm

Leaflet attached to the packaging: patient information

Nifuroksazyd Aflofarm, 100 mg, coated tablets

Nifuroxazidum

Please read the contents of the 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 patient leaflet or as directed by a doctor or pharmacist.

• This 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 side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement after 3 days or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

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

The medicine contains the active substance nifuroxazide. The medicine has antibacterial effects against most bacteria that cause intestinal infections.
The medicine does not affect the natural bacterial flora in the digestive tract.
The medicine works locally in the intestine. It is not absorbed from the digestive tract.

Indications for use:

treatment of acute or chronic diarrhea in the course of bacterial infections of the digestive tract (including traveler's diarrhea, food poisoning, gastritis).
This medicine is intended for use in adults and children over 6 years of age.
If there is no improvement after 3 days or the patient feels worse, they should consult a doctor.

2. Important information before taking Nifuroksazyd Aflofarm

When not to take Nifuroksazyd Aflofarm

• if the patient is allergic to nifuroxazide, nitrofuran derivatives, or any of the other ingredients of this medicine (listed in section 6);
• if the patient has a deficiency of glucose-6-phosphate dehydrogenase (risk of hemolytic anemia);
• in children under 6 years of age.

Warnings and precautions

Before starting to take Nifuroksazyd Aflofarm, the patient should discuss it with their doctor or pharmacist.
If diarrhea persists for more than 2 or 3 days, despite taking the medicine, or if the diarrhea worsens, the patient should contact their doctor immediately. The doctor will perform tests to determine the cause of the symptoms and decide on further treatment.
In case of an allergic reaction with symptoms such as: shortness of breath, rash, itching, the patient should stop taking the medicine.
Nifuroksazyd Aflofarm should be taken with a strict diet (see section: Nifuroksazyd Aflofarm with food, drink, and alcohol).
During treatment for diarrhea, it is necessary to constantly hydrate the body with a large amount of fluids (see section: Nifuroksazyd Aflofarm with food, drink, and alcohol).
In case of severe and prolonged diarrhea, severe vomiting, or loss of appetite, intravenous hydration should be considered.
As a precaution, Nifuroksazyd Aflofarm should not be taken during pregnancy and breastfeeding.

Children

This medicine should not be used in children under 6 years of age.

Nifuroksazyd Aflofarm and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Taking Nifuroksazyd Aflofarm with the following medicines may cause a risk of a disulfiram-like reaction (severe and life-threatening intolerance reaction):

• metronidazole(chemotherapy used to treat infections, including acne, peritonitis, sepsis);
• sulfonamides(medicines used to treat bacterial infections);
• cephalosporins(antibiotics);
• chloramphenicol(antibiotic);
• nitrofurantoin(antibiotic used to treat urinary tract infections);
• griseofulvin(antibiotic used to treat fungal infections).

Nifuroksazyd Aflofarm with food, drink, and alcohol

Tablets should be taken with a drink.

• The medicine should be taken with a strict diet, which involves excluding juices, raw vegetables, fruits, green vegetables, spicy dishes, as well as frozen food or drinks. It is recommended to eat rice and grilled meat.
• The body should be hydrated with a large amount of fluids, sweetened or salty drinks, to compensate for the loss of fluids caused by diarrhea (average water intake for an adult is 2 liters per day).
• During treatment with the medicine, alcohol should not be consumed, as it may cause severe and life-threatening intolerance reactions (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 their doctor or pharmacist before taking this medicine.
Pregnant women should not take this medicine unless it is prescribed by a doctor.
As a precaution, Nifuroksazyd Aflofarm should not be taken during pregnancy and breastfeeding. In women of childbearing age, Nifuroksazyd Aflofarm can be used only if they use effective contraception.

Driving and operating machinery

This medicine does not affect the ability to drive or operate machinery.

3. How to take Nifuroksazyd Aflofarm

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If there are any doubts, the patient should consult their doctor or pharmacist.
Recommended dose
Adults:8 tablets (800 mg) per day in 2-4 divided doses.
Children over 6 years of age:6-8 tablets (600 mg to 800 mg) per day in 2-4 divided doses.
Tablets should be swallowed whole, without chewing or crushing. They should be taken with a sufficient amount of liquid (a glass of water).
Without consulting a doctor, the medicine should not be taken for more than 3 days. The doctor may recommend longer treatment.

Taking a higher dose of Nifuroksazyd Aflofarm than recommended

In case of taking a higher dose of Nifuroksazyd Aflofarm than recommended or taking a large amount of the medicine by a child, the patient should consult their doctor or pharmacist.

Missing a dose of Nifuroksazyd Aflofarm

The missed dose should be taken as soon as possible. If it is almost time for the next dose, the patient should not take a double dose to make up for the missed one.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The patient should stop taking the medicine and contact their doctor or go to the Emergency Department of the nearest hospital immediately if they experience any of the following side effects:

• allergic reaction occurring within 20 minutes of taking the medicine (rash, severe swelling of the face, lips, or throat, difficulty breathing, speaking, or swallowing, sudden drop in blood pressure, slow or fast heart rate, paleness, anxiety, sweating, dizziness, loss of consciousness, respiratory or cardiac arrest) - frequency not known;
• angioedema (severe allergic reaction - sudden swelling of the face, limbs, or joints without itching or pain). Swelling in the head and neck area may cause difficulty swallowing or breathing - frequency not known.

This medicine is usually well-tolerated.
Frequency not known(frequency cannot be estimated from the available data):

• skin rash;
• urticaria;
• hemolytic anemia (in patients with a diagnosed deficiency of glucose-6-phosphate dehydrogenase, there is a risk of hemolytic anemia);
• abdominal pain, nausea, worsening of diarrhea.

Additional side effects in children and adolescents

None.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. 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
Phone: +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 can help gather more information on the safety of the medicine.

5. How to store Nifuroksazyd Aflofarm

The medicine should be stored out of sight and reach of children.
This medicine should not be taken after the expiry date stated on the packaging and blister after EXP.
The expiry date refers to the last day of the month.
Batch: means batch number.
Store in a temperature below 25°C.
Medicines should not be disposed of via wastewater or household waste containers. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Nifuroksazyd Aflofarm contains

• The active substance of the medicine is nifuroxazide. Each coated tablet contains 100 mg of nifuroxazide.
• Other ingredients are: corn starch, povidone K 30, microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate, Opadry II Yellow coating (polyvinyl alcohol, macrogol 3350, titanium dioxide (E 171), talc, quinoline yellow (E 104), lacquer, yellow iron oxide (E 172), red iron oxide (E 172), indigo carmine (E 132), lacquer).

What Nifuroksazyd Aflofarm looks like and what the package contains

Coated tablets, round, biconvex, with a diameter of 8.0 mm ± 0.2 mm, yellow, smooth, and uniform surface, without spots or damage.
The package contains 24 coated tablets in a PVC/PVDC/Aluminum blister pack in a cardboard box with a leaflet.

Marketing authorization holder

Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
phone: (42) 22-53-100

Manufacturer

Aflofarm Farmacja Polska Sp. z o.o.
ul. Szkolna 31
95-054 Ksawerów
Date of last revision of the leaflet:01.08.2022