Nifuroxazide gedeon richter

Package leaflet: information for the patient

NIFUROXAZIDE GEDEON RICHTER, 220 mg/5 ml, oral suspension
Nifuroxazidum
Read the entire leaflet carefully before using this medicine, as it contains important information for the patient.

• Keep this leaflet for future reference.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm others, even if their symptoms are similar.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of contents

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

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

Nifuroxazide Gedeon Richter is an antibacterial medicine. It exerts a local effect in the intestinal lumen against certain species of Gram-positive and Gram-negative bacteria.
Nifuroxazide Gedeon Richter does not destroy non-pathogenic bacteria normally present in the gastrointestinal tract. It does not induce the development of resistant bacterial strains. After oral administration, it is only partially absorbed (10–20%) from the gastrointestinal tract and is largely metabolized. The portion of nifuroxazide not absorbed in the gastrointestinal tract is excreted unchanged in feces.
Nifuroxazide Gedeon Richter is indicated for the treatment of the following conditions:

• Acute and chronic bacterial diarrhoea.
• Other conditions associated with diarrhoea, such as acute food poisoning.

2. Important information before using Nifuroksazyd Gedeon Richter

When not to use Nifuroksazyd Gedeon Richter

• If the patient is allergic to nifuroxazide or to any of the other ingredients of this medicine (listed in section 6). Allergic reactions may manifest as rash, itching, swelling of the face, lips, tongue, or difficulty breathing (if such symptoms occur, contact a doctor immediately).
• Do not use in premature infants and newborns under one month of age.

Warnings and precautions

• If diarrhea persists after 3 days of treatment, the doctor will perform tests to determine the cause of symptoms and may consider starting antibiotic treatment.
• In cases of severe diarrhea, instead of Nifuroksazyd Gedeon Richter, the patient should take a systemic-acting antibiotic, because nifuroxazide is only partially absorbed (10–20%) from the gastrointestinal tract after oral administration.

During treatment of diarrhea, it is essential to continuously replenish fluids (orally or intravenously), depending on the patient's general condition (average fluid intake for an adult patient – 2 liters per day), to compensate for fluid loss caused by diarrhea. In cases of severe and prolonged diarrhea, severe vomiting, or refusal to eat, intravenous rehydration should be considered.

• The medicine may cause allergic reactions (including delayed-type reactions). If allergic symptoms such as difficulty breathing, rash, or itching occur, discontinue use of Nifuroksazyd Gedeon Richter.
• Nifuroksazyd Gedeon Richter should be used in conjunction with a diet that excludes fruit juices, raw vegetables and fruits, spicy and hard-to-digest foods, as well as ice cream and cold beverages.
• As a precautionary measure, Nifuroksazyd Gedeon Richter should not be administered during pregnancy and breastfeeding.

Contact a doctor even if the above warnings relate to conditions that occurred in the past.

Nifuroksazyd Gedeon Richter and other medicines

Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines planned for future use.
Nifuroxazide reduces the absorption of many drugs from the gastrointestinal tract. Therefore, other oral medicines should not be taken simultaneously during treatment with Nifuroksazyd Gedeon Richter.

Nifuroksazyd Gedeon Richter with food, drink, and alcohol

Ensure appropriate food intake during episodes of diarrhea, avoiding certain products, especially fruit juices, raw vegetables and fruits, spicy and hard-to-digest foods, as well as ice cream and cold beverages. Baked meat and rice are recommended.
Drinking alcohol during treatment with Nifuroksazyd Gedeon Richter may cause acute and serious intolerance reactions (so-called disulfiram-like reactions).

Pregnancy and breastfeeding

As a precautionary measure, Nifuroksazyd Gedeon Richter should not be used during pregnancy and breastfeeding. In women of childbearing age, Nifuroksazyd Gedeon Richter should only be used if effective contraception is being applied.

Driving and operating machinery

Nifuroksazyd Gedeon Richter has no effect on the ability to drive, operate machinery, or use tools.

Nifuroksazyd Gedeon Richter contains sucrose. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

Nifuroksazyd Gedeon Richter contains methyl parahydroxybenzoate. Due to the presence of methyl parahydroxybenzoate, this medicine may cause allergic reactions (including delayed-type reactions).

3. How to use Nifuroksazyd Gedeon Richter

This medicine should always be used as directed by the physician. If in doubt, consult a doctor or pharmacist.

The usual dosage is:

• In children from 1 month up to 6 months of age: 2.5–5 ml of suspension (1 small or 1 large measuring spoon) twice daily, every 12 hours;
• In children from 7 months to 6 years of age: 5 ml of suspension (1 large measuring spoon) three times daily, every 8 hours;
• In adults and children from 7 years of age: 5 ml of suspension (1 large measuring spoon) four times daily, every 6 hours.

Nifuroksazyd Gedeon Richter is administered orally.
The medicine should be taken at regular intervals throughout the day.
Shake the bottle well before each use to obtain a uniform suspension. The suspension may be taken with water.
Nifuroksazyd Gedeon Richter should not be used for longer than 7 days.

During treatment of acute diarrhoea with Nifuroksazyd Gedeon Richter, it is essential to maintain adequate hydration, preferably with water, sweetened or flavored drinks (average fluid intake for an adult patient – 2 liters per day), in order to replace fluids lost due to diarrhoea. The physician will determine the appropriate amount of oral or intravenous fluids depending on the patient's general condition. In cases of severe and prolonged diarrhoea, severe vomiting, or refusal to eat, intravenous rehydration should be considered.

If you feel that the effect of Nifuroksazyd Gedeon Richter is too strong or too weak, consult your doctor.

Taking more than the recommended dose of Nifuroksazyd Gedeon Richter
In case of overdose, seek immediate medical advice. Show the doctor the container of the suspension.

Missing a dose of Nifuroksazyd Gedeon Richter
Take the next dose at the scheduled time.
Do not take a double dose to make up for a missed dose.

Stopping treatment with Nifuroksazyd Gedeon Richter
Do not discontinue treatment before 7 days have passed without consulting your doctor, even if the patient feels better.

If you have any further questions 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 everybody will experience them.
Severe, life-threatening adverse reactions have not been observed after taking the medicine
Nifuroksazyd Gedeon Richter, with the exception of one case of granulocytopenia (reduction in
the number of a certain type of white blood cells – granulocytes).
The occurrence of severe adverse symptoms may require immediate medical assistance and
hospital treatment.
The following adverse reactions may occur:

• abdominal pain
• nausea
• worsening of diarrhoea

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

• rash
• skin blisters
• itching and skin nodules

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

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

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 Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Nifuroksazyd Gedeon Richter
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "EXP".
The expiry date refers to the last day of the stated month.
Do not store above 25°C.
Do not use this medicine after 3 months from opening the bottle.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the package and other information

What Nifuroksazyd Gedeon Richter contains

• The active substance is nifuroxazide. 5 ml of suspension contains 220 mg of nifuroxazide.
  The other ingredients are: carbomer, sucrose, citric acid, sodium hydroxide, methyl parahydroxybenzoate, simethicone emulsion 30%, purified water, banana flavouring.

What Nifuroksazyd Gedeon Richter looks like and contents of the pack
Nifuroksazyd Gedeon Richter is a light yellow oral suspension with a banana odour.
The suspension may settle slightly at the bottom of the bottle, but should return to a uniform dispersion after shaking.
Nifuroksazyd Gedeon Richter oral suspension 220 mg/5 ml is packed in an amber glass bottle.
➢ Amber glass bottle of 125 ml, containing 90 ml of suspension
Each bottle is closed with a PP28S cap equipped with a tamper-evident ring made of HDPE, a dosing device made of HDPE/LDPE, and a double measuring spoon (5 ml; 2.5 ml) made of white polystyrene.

Marketing Authorisation Holder:
GEDEON RICHTER POLSKA Sp. z o.o.
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Poland
Tel.: +48 (22) 755 50 81

Manufacturer:
GEDEON RICHTER POLSKA Sp. z o.o.
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Poland
Gedeon Richter România S.A.,
Str. Cuza Vodă 99-105,
Târgu–Mureş – 540306,
Romania

For further information about this medicinal product, 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
[email protected]

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