Nifuroksazid Gedeon Rihter

Package Leaflet: Information for the Patient

NIFUROXAZIDE GEDEON RICHTER, 100 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 the package leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any side effects, including those not listed in the leaflet, tell your doctor or pharmacist. See section 4.
• If you do not feel better or if you feel worse, you should contact your doctor.

Table of Contents of the Leaflet

• 1. What is Nifuroksazyd Gedeon Richter and what is it used for
• 2. Important information before taking Nifuroksazyd Gedeon Richter
• 3. How to take Nifuroksazyd Gedeon Richter
• 4. Possible side effects
• 5. How to store Nifuroksazyd Gedeon Richter
• 6. Contents of the pack and other information

1. What is Nifuroksazyd Gedeon Richter and what is it used for

Nifuroksazyd Gedeon Richter is an antibacterial medicine. It has a local effect in the gut against certain species of bacteria.
Nifuroksazyd Gedeon Richter does not destroy non-pathogenic bacteria that are normally present in the digestive tract. It does not cause the formation of bacterial strains resistant to its action. After oral administration, it is only partially (10-20%) absorbed from the gastrointestinal tract and is largely metabolized. Nifuroksazyd that has not been absorbed in the gastrointestinal tract is excreted unchanged in the feces.

Nifuroksazyd Gedeon Richter is used to treat the following diseases and conditions:

• Acute and chronic bacterial diarrhea.
• Other conditions accompanied by diarrhea.

2. Important information before taking Nifuroksazyd Gedeon Richter

When not to take Nifuroksazyd Gedeon Richter

• If you are allergic (hypersensitive) to nifuroxazide or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may manifest as swelling of the face, lips, tongue, or difficulty breathing (if such symptoms occur, you should contact your doctor immediately).
• Do not use in children under 7 years of age, as they may have difficulty swallowing the tablet.

Warnings and precautions

• If diarrhea persists for more than 3 days despite taking Nifuroksazyd Gedeon Richter, you should contact your doctor. 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 rash, itching, you should stop taking Nifuroksazyd Gedeon Richter.
• Nifuroksazyd Gedeon Richter should be taken in combination with a diet that excludes juices, raw vegetables and fruits, as well as spicy and hard-to-digest foods, and also ice cream and cold drinks. It is recommended to eat baked meat and rice.
• During the treatment of diarrhea, it is necessary to constantly replenish fluids (orally or intravenously) depending on the patient's general condition (average water intake for an adult patient - 2 liters per day), in order to replenish the fluid loss caused by diarrhea. In case of severe and prolonged diarrhea, severe vomiting, or reluctance to eat, intravenous rehydration should be considered.
• As a precautionary measure, Nifuroksazyd Gedeon Richter should not be taken during pregnancy and breastfeeding.

Nifuroksazyd Gedeon Richter and other medicines

Nifuroksazyd Gedeon Richter reduces the absorption of many medicines from the gastrointestinal tract.
If you are taking other medicines, you should consult your doctor before starting treatment with Nifuroksazyd Gedeon Richter.

Nifuroksazyd Gedeon Richter with food and drink

You should ensure adequate food intake during diarrhea, avoiding certain products, especially juices, raw vegetables and fruits, as well as spicy and hard-to-digest foods, and also ice cream and cold drinks. It is recommended to eat baked meat and rice.
Drinking alcohol while taking Nifuroksazyd Gedeon Richter may cause acute and severe intolerance reactions (so-called disulfiram-like reactions).

Pregnancy and breastfeeding

As a precautionary measure, Nifuroksazyd Gedeon Richter should not be taken during pregnancy and breastfeeding. In women of childbearing age, Nifuroksazyd Gedeon Richter can be used only if they use effective contraception.

Driving and using machines

Nifuroksazyd Gedeon Richter does not affect the ability to drive vehicles, operate machinery, and use tools.

3. How to take Nifuroksazyd Gedeon Richter

• Adults and children over 7 years of age usually take 2 tablets 4 times a day, every 6 hours.
• Nifuroksazyd Gedeon Richter is taken orally. Tablets should be swallowed whole,washed down with a sufficient amount of liquid, for example, a glass of water. Tablets should not be chewed or crushed.
• If symptoms worsen or do not improve after 3 days, you should contact your doctor.
• Nifuroksazyd Gedeon Richter should not be taken for more than 3 days without consulting a doctor. During the treatment of diarrhea with Nifuroksazyd Gedeon Richter, it is necessary to constantly replenish fluids orally, you should drink large amounts of fluids, preferably water, sweet or flavored drinks (average water intake for an adult patient - 2 liters per day), in order to replenish the fluid loss caused by diarrhea. In case of severe and prolonged diarrhea, severe vomiting, or reluctance to eat, intravenous rehydration should be considered. If you feel that the effect of Nifuroksazyd Gedeon Richter is too strong or too weak, you should consult your doctor.

In case of any doubts about the use of this medicine, you should consult your doctor or pharmacist.

Taking a higher dose of Nifuroksazyd Gedeon Richter than recommended

In case of taking a higher dose of Nifuroksazyd Gedeon Richter than recommended, you should immediately consult your doctor. You should show the doctor the package with the tablets.

Missing a dose of Nifuroksazyd Gedeon Richter

The next dose should be taken at the scheduled time.
You should not take a double dose to make up for the missed dose.

Stopping treatment with Nifuroksazyd Gedeon Richter

You should not stop treatment before the end of 3 days, even if you feel better.
In case of any doubts about the use of this medicine, you should consult your doctor or pharmacist.

Possible side effects

Like all medicines, Nifuroksazyd Gedeon Richter can cause side effects, although not everybody gets them.
No severe, life-threatening side effects have been observed after taking Nifuroksazyd Gedeon Richter, except for one case of granulocytopenia (decrease in the number of a certain type of white blood cell - granulocytes).
In individual cases of allergic reactions to nifuroxazide, the following side effects may occur:

• abdominal pain,
• nausea,
• worsening of diarrhea.

Additionally, the following side effects may occur rarely (in at least 1 in 10,000, but less than 1 in 1,000 patients):

• rash,
• pustules on the skin,
• itching and hives on the skin.

With an unknown frequency (frequency cannot be estimated from the available data), the following side effects may occur:

• allergic reactions, such as skin rash, urticaria, angioedema, anaphylactic shock.

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, you should 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 tel.: +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 medicine.

5. How to store Nifuroksazyd Gedeon Richter

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the blisters after the words "Exp:". The expiry date refers to the last day of the month.
Do not store above 25°C.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Nifuroksazyd Gedeon Richter contains

The active substance of the medicine is nifuroxazide. Each film-coated tablet contains 100 mg of nifuroxazide.
The other ingredients are: colloidal silica, potato starch, gelatin, talc, magnesium stearate, hypromellose, titanium dioxide, macrogol 20000, quinoline yellow (E 104).

What Nifuroksazyd Gedeon Richter looks like and contents of the pack

Nifuroksazyd Gedeon Richter is a yellow, round, biconvex film-coated tablet

GEDEON RICHTER POLSKA Sp. z o.o.
ul. ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Poland
tel.: +48 (22) 755 50 81
For more detailed information, please contact:
GEDEON RICHTER POLSKA Sp. z o.o.
Medical Department
ul. ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Tel. +48 (22)755 96 48
lekalert@grodzisk.rgnet.org

Date of last revision of the leaflet:

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