Package leaflet: Information for the patient

Nifuroxasid Aflofarm, 100 mg, coated tablets
Nifuroxazidum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
the physician 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 not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 3 days, or if you feel worse, consult your doctor.

Table of contents of the leaflet

What Nifuroxasid Aflofarm is and what it is used for
Important information before taking Nifuroxasid Aflofarm
How to take Nifuroxasid Aflofarm
Possible side effects
How to store Nifuroxasid Aflofarm
Contents of the pack and other information

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

The medicine contains the active substance nifuroxazid. The medicine exhibits antibacterial activity against
most bacteria causing intestinal infections.
This medicine does not affect the natural bacterial flora of the gastrointestinal tract.
The medicine acts locally within the intestinal lumen. It is not absorbed from the gastrointestinal tract.
Indications:
treatment of acute or chronic diarrhoea due to bacterial infections of the gastrointestinal tract (e.g. traveller's diarrhoea, foodborne diarrhoea, gastroenteritis).
This medicine is intended for use in adults and children above 6 years of age.
If there is no improvement after 3 days, or if you feel worse, consult your 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 glucose-6-phosphate dehydrogenase deficiency (risk of developing haemolytic anaemia);
in children under 6 years of age.

Warnings and precautions
Before starting treatment with Nifuroksazyd Aflofarm, consult your doctor or pharmacist.
If diarrhoea persists for more than 2 or 3 days despite treatment, or if diarrhoea worsens, contact your doctor immediately. The doctor will perform tests to determine the cause of symptoms and decide on further treatment.
If an allergic reaction occurs with symptoms such as shortness of breath, rash, or itching, discontinue use of the medicine.
Nifuroksazyd Aflofarm should be used in combination with a diet (see section: Nifuroksazyd Aflofarm with food, drink and alcohol).
During treatment for diarrhoea, it is essential to maintain constant hydration by drinking large amounts of fluids (see section: Nifuroksazyd Aflofarm with food, drink and alcohol).
In cases of severe and prolonged diarrhoea, severe vomiting, or loss of appetite, intravenous rehydration should be considered.
As a precautionary measure, Nifuroksazyd Aflofarm should not be administered during pregnancy or breastfeeding.

Children
Do not use in children under 6 years of age.

Nifuroksazyd Aflofarm and other medicines
Inform 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.
Concomitant use of Nifuroksazyd Aflofarm with the following medicines may cause a risk of disulfiram-like reactions (acute and health-threatening intolerance reactions):

metronidazole (a chemotherapeutic agent used in the treatment of infections, including rosacea, peritonitis, and sepsis);
sulfonamides (medicines used to treat bacterial infections);
cephalosporins (antibiotics);
chloramphenicol (an antibiotic);
nitrofurantoin (an antibiotic used in the treatment of urinary tract infections);
griseofulvin (an antibiotic used in the treatment of fungal infections).

Nifuroksazyd Aflofarm with food, drink and alcohol
Tablets should be taken with liquid.

The medicine should be taken together with a strict diet, which involves excluding fruit juices, raw vegetables, fruits, green vegetables, spicy foods, as well as frozen foods or beverages. Consumption of rice and grilled meat is recommended.
The body should be hydrated with large amounts of fluids, including sweetened or salty drinks, to compensate for fluid loss caused by diarrhoea (average daily water intake for an adult is 2 litres).
Alcohol must not be consumed during treatment, as it may cause acute and health-threatening intolerance reactions (so-called disulfiram-like reactions).

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Pregnant women should not use this medicine unless specifically prescribed by a doctor.
As a precautionary measure, Nifuroksazyd Aflofarm should not be administered during pregnancy or breastfeeding. In women of childbearing age, Nifuroksazyd Aflofarm should only be used if effective contraception is applied.

Driving and operating machinery
This medicine has no effect on 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 information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.

Recommended dose
Adults: 8 tablets (800 mg) per day, divided into 2 to 4 doses.
Children over 6 years of age: 6 to 8 tablets (600 mg to 800 mg) per day, divided into 2 to 4 doses.

The tablets should be swallowed whole, not chewed or crushed, with an adequate amount of liquid (a glass of water).

Do not take this medicine for longer than 3 days without consulting a doctor. A doctor may recommend a longer duration of treatment.

Taking more than the recommended dose of Nifuroksazyd Aflofarm
If a larger than recommended dose of Nifuroksazyd Aflofarm is taken, or if a child takes a large amount of the medicine, consult a doctor or pharmacist immediately.

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 one.

If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Treatment with this medicine must be discontinued and immediate contact with a doctor sought
or go to the nearest hospital Emergency Department if the patient develops any of the
following adverse symptoms:

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 rapid heartbeat, pallor, restlessness, sweating, dizziness, loss of consciousness, respiratory arrest and cardiac arrest) – frequency unknown;
angioedema (serious allergic reaction - sudden swelling of the face, limbs or joints without itching or pain). Swelling involving the head and neck may cause difficulty in swallowing and breathing – frequency unknown.

This medicine is generally well tolerated.
Frequency unknown (frequency cannot be estimated from the available data):

skin rash;
urticaria;
haemolytic anaemia (in patients with known glucose-6-phosphate dehydrogenase deficiency, there is a risk of haemolytic anaemia);
abdominal pain, nausea, worsening diarrhoea.

Additional adverse reactions in children and adolescents
None.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor or pharmacist. Adverse reactions can be
reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Nifuroksazyd Aflofarm

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack after EXP.
The expiry date refers to the last day of the stated month.
Lot: means batch number.
Store below 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Nifuroksazyd Aflofarm contains

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

What Nifuroksazyd Aflofarm looks like and contents of the pack
Coated tablets, round, biconvex, 8.0 mm ± 0.2 mm in diameter, yellow in colour,
smooth with a uniform surface, without spots or damage.
The pack contains 24 coated tablets in a PVC/PVDC/Aluminium blister, placed
in a cardboard box with a leaflet.
Marketing Authorisation Holder
Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
tel. (42) 22-53-100
Manufacturer
Aflofarm Farmacja Polska Sp. z o.o.
ul. Szkolna 31
95-054 Ksawerów