Nifuroksazid Gedeon Rihter

Leaflet attached to the packaging: patient information

NIFUROXAZIDE GEDEON RICHTER, 200 mg,

hard capsules
Nifuroxazidum

Read 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 the patient leaflet or as advised 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 possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse, they should contact their 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. Package contents 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 gastrointestinal tract. It does not cause the development of bacterial strains resistant to its action. After oral administration, only a portion (10-20%) is absorbed from the gastrointestinal tract and is largely metabolized. The nifuroxazide that is not 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

Warnings and precautions

• If diarrhea persists for more than 3 days despite taking Nifuroksazyd Gedeon Richter, the patient should contact their doctor. The doctor will perform tests to determine the cause of the symptoms and decide on further treatment.
• In the event of an allergic reaction with symptoms such as rash, itching, the patient 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 frozen foods and cold drinks.
• 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 fluids lost due to diarrhea. In the 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 the patient is taking other medicines, they should consult their doctor before starting treatment with Nifuroksazyd Gedeon Richter.

Nifuroksazyd Gedeon Richter with food and drink

Adequate food intake should be ensured during the treatment of diarrhea, avoiding certain products, especially juices, raw vegetables and fruits, as well as spicy and hard-to-digest foods, and also frozen foods 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 only be used if they are using effective contraception.

Driving and operating machinery

Nifuroksazyd Gedeon Richter does not affect the ability to drive vehicles, operate machinery, and use tools.
Nifuroksazyd Gedeon Richter contains sucrose. If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking the medicine.

3. How to take Nifuroksazyd Gedeon Richter

• The usual dose for adults and children over 7 years of age is 1 capsule taken 4 times a day, every 6 hours.
• Nifuroksazyd Gedeon Richter is taken orally. Capsules should be swallowed

whole, with a sufficient amount of liquid, for example, a glass of water.

• If symptoms worsen or do not improve after 3 days, the patient should contact their 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, so the patient should drink plenty of fluids, preferably water, sweet or flavored drinks (average water intake for an adult patient - 2 liters per day), in order to replenish the fluids lost due to diarrhea. In the case of severe and prolonged diarrhea, severe vomiting, or reluctance to eat, intravenous rehydration should be considered.

If the patient feels that the effect of Nifuroksazyd Gedeon Richter is too strong or too weak, they should consult their doctor.

Taking a higher dose of Nifuroksazyd Gedeon Richter than recommended

In the event of taking a higher dose of Nifuroksazyd Gedeon Richter than recommended, the patient should immediately consult their doctor. The patient should show the doctor the package with the capsules.

Missing a dose of Nifuroksazyd Gedeon Richter

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

Stopping treatment with Nifuroksazyd Gedeon Richter

Treatment should not be stopped before 3 days have passed, even if the patient feels better.
If the patient has any further doubts about the use of this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Nifuroksazyd Gedeon Richter can cause side effects, although not everybody gets them.
No serious, 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 any side effects occur, including any side effects not listed in the leaflet, the patient 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, 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, more information can be collected on the safety of the medicine.

5. How to store Nifuroksazyd Gedeon Richter

Nifuroksazyd Gedeon Richter does not require special storage conditions.
The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiration date stated on the package and on the blisters after:
“Exp:”. The expiration date refers to the last day of the specified month.
Medicines should not be disposed of in the sewage system or in 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 Gedeon Richter contains

• The active substance of the medicine is nifuroxazide. Each hard capsule contains 200 mg of nifuroxazide.
• The other ingredients are: corn starch, corn starch gel, sucrose, magnesium stearate, gelatin, yellow iron oxide, titanium dioxide.

What Nifuroksazyd Gedeon Richter looks like and what the package contains

Nifuroksazyd Gedeon Richter is a yellow, hard gelatin capsule.
The package - a cardboard box - contains 12 capsules.

Marketing authorization holder and manufacturer

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 the last update of the leaflet:

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