Nifuroksazid Aflofarm

Package Leaflet: Information for the Patient

Nifuroksazyd Aflofarm, 200 mg, Film-Coated Tablets

Nifuroxazide

Read the Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

This medication should always be taken exactly as described in this patient leaflet or as advised by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, consult a pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or you feel worse, contact a 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. Contents of the pack and other information

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

The medication contains the active substance nifuroxazide. The medication exhibits antibacterial activity against most bacteria that cause intestinal infections.
The medication does not affect the natural bacterial flora in the gastrointestinal tract.
The medication acts locally in the intestine. It is not absorbed from the gastrointestinal tract.

Indications for use:

treatment of acute or chronic diarrhea in the course of bacterial infections of the gastrointestinal tract (including traveler's diarrhea, food poisoning, gastritis).
This medication is intended for use in adults and children over 6 years of age.
If after 3 days there is no improvement or the patient feels worse, 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 medication (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, discuss it with a doctor or pharmacist.
If diarrhea persists for more than 2 or 3 days, despite taking the medication, or if the diarrhea worsens, contact a 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, discontinue the medication.
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, consider intravenous hydration.
As a precaution, Nifuroksazyd Aflofarm should not be taken during pregnancy and breastfeeding.

Children

Do not use in children under 6 years of age.

Nifuroksazyd Aflofarm and other medications

Tell your doctor or pharmacist about all medications you are currently taking or have recently taken, as well as any medications you plan to take.
Taking Nifuroksazyd Aflofarm with the following medications may cause a risk of a disulfiram-like reaction (acute and life-threatening intolerance reaction):

• metronidazole(chemotherapy used to treat infections, including acne, peritonitis, sepsis);
• sulfonamides(medications 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 liquid.

• The medication 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.
• Hydrate the body with a large amount of fluids, sweetened or salty drinks, to replenish fluids lost due to diarrhea (average water intake for an adult is 2 liters per day).
• During treatment with the medication, do not drink alcohol, as it may cause acute and life-threatening intolerance reactions (so-called disulfiram-like reactions).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult a doctor or pharmacist before taking this medication.
Pregnant women should not take this medication 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 medication does not affect the ability to drive and operate machinery.

3. How to take Nifuroksazyd Aflofarm

This medication should always be taken exactly as described in this patient leaflet or as advised by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Recommended dose
Adults:4 tablets (800 mg) per day in 2-4 divided doses.
Children over 6 years of age:3 to 4 tablets (600 mg to 800 mg) per day in 2-4 divided doses.
Swallow the tablets whole, do not chew or crush. Take with a sufficient amount of liquid (a glass of water).
Without consulting a doctor, do not take the medication for more than 3 days. A doctor may recommend longer use of the medication.

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 medication by a child, consult a doctor or pharmacist.

Missing a dose of Nifuroksazyd Aflofarm

Take the missed dose as soon as possible. If it is almost time for the next dose, do not take a double dose to make up for the missed dose.
In case of any further doubts about the use of this medication, consult a doctor or pharmacist.

4. Possible side effects

Like all medications, Nifuroksazyd Aflofarm can cause side effects, although not everybody gets them.

Stop taking the medication and contact a doctor or go to the Emergency Department of the nearest hospital immediately if you experience any of the following side effects:

• allergic reaction occurring within 20 minutes of taking the medication (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, and 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 and breathing - frequency not known.

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

• skin rash;
• hives;
• 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 you experience any side effects, including those not listed in this leaflet, tell your 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.
By reporting side effects, you can help provide more information on the safety of this medication.

5. How to store Nifuroksazyd Aflofarm

Keep the medication out of sight and reach of children.
Do not use this medication after the expiry date stated on the carton and blister after EXP.
The expiry date refers to the last day of the month.
Batch: means batch number.
Store below 25°C.
Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Nifuroksazyd Aflofarm contains

• The active substance of the medication is nifuroxazide. Each film-coated tablet contains 200 mg of nifuroxazide.
• Other ingredients are: cornstarch, povidone K 30, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate, Opadry II White coating (polyvinyl alcohol, macrogol 3350, titanium dioxide (E 171), talc).

What Nifuroksazyd Aflofarm looks like and contents of the pack

Film-coated tablets, round, biconvex, 10.0 mm ± 0.3 mm in diameter, white, smooth, and uniform surface, without spots or damage.
The pack contains 12 film-coated tablets in a PVC/PVDC/Aluminum blister pack in a cardboard box with a patient 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