Package leaflet: Information for the patient

Nifuroxazid Aflofarm, 200 mg, coated tablets
Nifuroxazidum
Please read 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, as you may need to read it again.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any adverse reactions 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

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

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

The medicine contains the active substance nifuroxazide. 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 over 6 years of age.
If there is no improvement after 3 days, or if you feel worse, consult your doctor.

2. Information before taking Nifuroxazide Aflofarm

When not to take Nifuroxazide 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 haemolytic anaemia);
in children under 6 years of age.

Warnings and precautions
Before starting treatment with Nifuroxazide Aflofarm, discuss it with 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 allergic reactions occur with symptoms such as shortness of breath, rash, or itching, discontinue use of the medicine.
Nifuroxazide Aflofarm should be taken together with a proper diet (see section: Nifuroxazide Aflofarm with food, drink and alcohol).
During treatment of diarrhoea, it is essential to maintain constant hydration by drinking large amounts of fluids (see section: Nifuroxazide 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, Nifuroxazide Aflofarm should not be administered during pregnancy and breastfeeding.

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

Nifuroxazide Aflofarm with other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines you plan to take.
Concomitant use of Nifuroxazide Aflofarm with the following medicines may increase the 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 (antibiotic);
nitrofurantoin (antibiotic used in the treatment of urinary tract infections);
griseofulvin (antibiotic used in the treatment of fungal infections).

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

The medicine should be taken together with a strict diet excluding fruit juices, raw vegetables, fruits, green vegetables, spicy foods, as well as frozen foods or drinks. Consumption of rice and grilled meat is recommended.
The body should be hydrated with large amounts of fluids, 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 her doctor or pharmacist before using this medicine.
Pregnant women should not use this medicine unless specifically prescribed by a doctor.
As a precautionary measure, Nifuroxazide Aflofarm should not be administered during pregnancy and breastfeeding. In women of childbearing age, Nifuroxazide Aflofarm may be used only if effective contraception is used.

Driving and operating machinery
This medicine has no influence on the ability to drive or operate machinery.

3. How to take the medicine Nifuroksazyd Aflofarm

This medicine should always be taken exactly as described in this patient leaflet or as advised by your doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.
Recommended dose
Adults: 4 tablets (800 mg) per day in 2–4 divided doses.
Children over 6 years of age: from 3 to 4 tablets (600 mg to 800 mg) per day in 2–4 divided doses.
The tablets should be swallowed whole, not chewed or crushed. Take with an adequate amount of fluid (a glass of water).
Do not take this medicine for longer than 3 days without consulting a doctor. Your doctor may recommend longer treatment.
Taking more than the recommended dose of Nifuroksazyd Aflofarm
If you take more than the recommended dose of Nifuroksazyd Aflofarm or if a child takes a large amount of the medicine, consult your 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 about 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.
You must stop using this medicine immediately and contact your doctor or go to the Emergency Department of the nearest hospital if any of the following adverse symptoms occur in the patient:

Hypersensitivity reaction occurring within 20 minutes after 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 or cardiac arrest) – frequency unknown;
Angioedema (serious allergic reaction – sudden swelling of the face, limbs or joints without itching or pain). Swelling in the head and neck area may cause difficulty in swallowing and breathing – frequency unknown.

This medicine is generally well tolerated.
Frequency unknown (frequency cannot be estimated from 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 at 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to improve the safety information available for this medicine.

5. How to store Nifuroksazyd Aflofarm

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following EXP.
The expiry date refers to the last day of the stated month.
Lot: indicates the 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 no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What Nifuroksazyd Aflofarm contains

The active substance is nifuroxazide. Each coated tablet contains 200 mg of nifuroxazide.
The other ingredients are: pregelatinized starch, povidone K 30, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate, coating Opadry II White (polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide (E 171), talc).

What Nifuroksazyd Aflofarm looks like and contents of the pack
Coated tablets, round, biconvex, 10.0 mm ± 0.3 mm in diameter, white in colour,
smooth with a uniform surface, free from spots and defects.
The pack contains 12 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