Nifuroksazid Gedeon Rihter

Leaflet attached to the packaging: patient information

NIFUROXAZIDE GEDEON RICHTER, 220 mg/5 ml, oral suspension

Nifuroxazide

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Nifuroxazide Gedeon Richter and what is it 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. Package contents and other information

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

Nifuroxazide Gedeon Richter is an antibacterial medicine. It has a local effect in the intestine on certain species of Gram-positive and Gram-negative bacteria. Nifuroxazide Gedeon Richter does not destroy non-pathogenic bacteria that normally occur 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 digestive tract and is largely metabolized. The nifuroxazide that has not been absorbed in the digestive tract is excreted unchanged in the feces.

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

• Acute and chronic bacterial diarrhea.
• Other conditions accompanied by diarrhea, such as acute food poisoning.

2. Important information before taking Nifuroxazide Gedeon Richter

When not to take Nifuroxazide Gedeon Richter

• If the patient is allergic to nifuroxazide or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may manifest as a rash, itching, swelling of the face, lips, tongue, or difficulty breathing (if such symptoms occur, consult a doctor immediately).
• Do not use in premature infants and newborns before the end of the first month of life.

Warnings and precautions

• In case of persistent diarrhea after 3 days of treatment, the doctor will perform tests to determine the cause of the symptoms and consider starting antibiotic treatment.
• In case of severe diarrhea, instead of Nifuroxazide Gedeon Richter, the patient should take an antibiotic that acts systemically, because nifuroxazide is only partially (10-20%) absorbed from the digestive tract after oral administration.

During diarrhea treatment, 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 refusal to eat, intravenous rehydration should be considered.

• The medicine may cause allergic reactions (possible late-type reactions). In case of an allergic reaction with symptoms such as difficulty breathing, rash, itching, discontinue use of Nifuroxazide Gedeon Richter.
• Nifuroxazide Gedeon Richter should be used in combination with a diet that excludes juices, raw vegetables and fruits, as well as spicy and hard-to-digest foods, and frozen and cold drinks.
• As a precaution, Nifuroxazide Gedeon Richter should not be administered during pregnancy and breastfeeding.

Consult a doctor even if the above warnings refer to situations that have occurred in the past.

Nifuroxazide Gedeon Richter and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take. Nifuroxazide reduces the absorption of many medicines from the digestive tract. Therefore, during treatment with Nifuroxazide Gedeon Richter, do not take other oral medicines at the same time.

Nifuroxazide Gedeon Richter with food, drink, and alcohol

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 frozen and cold drinks. It is recommended to eat baked meat and rice. Drinking alcohol while taking Nifuroxazide Gedeon Richter may cause acute and severe intolerance reactions (so-called disulfiram-like reactions).

Pregnancy and breastfeeding

As a precaution, Nifuroxazide Gedeon Richter should not be administered during pregnancy and breastfeeding. In women of childbearing age, Nifuroxazide Gedeon Richter can only be used if they are using effective contraception.

Driving and operating machinery

Nifuroxazide Gedeon Richter does not affect the ability to drive vehicles, operate machinery, and use tools. Nifuroxazide Gedeon Richter contains sucrose.If the patient has previously been diagnosed with intolerance to certain sugars, they should consult a doctor before taking the medicine. Nifuroxazide Gedeon Richter contains methyl parahydroxybenzoate.Due to the presence of methyl parahydroxybenzoate, the medicine may cause allergic reactions (possible late-type reactions).

3. How to take Nifuroxazide Gedeon Richter

Always take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist. The usual dose is:

• For children over 1 month to 6 months: 2.5-5 ml of suspension (1 small or 1 large measuring spoon) 2 times a day, every 12 hours;
• For children from 7 months to 6 years: 5 ml of suspension (1 large measuring spoon) 3 times a day, every 8 hours;
• For adults and children from 7 years: 5 ml of suspension (1 large measuring spoon) 4 times a day, every 6 hours.

Nifuroxazide Gedeon Richter is taken orally. The medicine should be taken at regular intervals throughout the day. Shake the bottle well before use to obtain a uniform suspension, and can be taken with water. Do not take Nifuroxazide Gedeon Richter for more than 7 days. During treatment of acute diarrhea with Nifuroxazide Gedeon Richter, it is necessary to constantly replenish fluids, preferably with 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. The doctor will prescribe the appropriate amount of fluids to be taken orally or intravenously, depending on the patient's general condition. In case of severe and prolonged diarrhea, severe vomiting, or refusal to eat, intravenous rehydration should be considered. If you feel that the effect of Nifuroxazide Gedeon Richter is too strong or too weak, consult your doctor.

Taking a higher dose of Nifuroxazide Gedeon Richter than recommended

In case of taking a higher dose of the medicine than recommended, consult a doctor immediately. Show the doctor the packaging of the suspension.

Missing a dose of Nifuroxazide Gedeon Richter

Take the next dose at the scheduled time. Do not take a double dose to make up for the missed dose.

Stopping treatment with Nifuroxazide Gedeon Richter

Do not stop treatment before the end of 7 days without consulting a doctor, even if you feel better. If you have any further doubts about the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Nifuroxazide Gedeon Richter can cause side effects, although not everybody gets them. No severe, life-threatening side effects have been observed after taking Nifuroxazide Gedeon Richter, except for one case of granulocytopenia (decrease in the number of a certain type of white blood cell - granulocytes).

The occurrence of severe side effects may require immediate medical attention and hospital treatment.

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
• Pimples on the skin
• Itching and hives on the skin

The following side effects may occur with an unknown frequency (frequency cannot be estimated from available data):

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

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, inform 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 Nifuroxazide 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 month stated. 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. This will help protect the environment.

6. Package contents and other information

What Nifuroxazide 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 flavor.

What Nifuroxazide Gedeon Richter looks like and what the package contains

Nifuroxazide Gedeon Richter is a yellow oral suspension with a banana flavor. The suspension may sediment slightly at the bottom of the bottle, but after shaking, it should return to a uniform dispersion. The package - a cardboard box - contains a bottle with 90 ml of suspension and a double measuring spoon.

Marketing authorization 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 more information about the medicine, consult: 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]

Date of last revision of the leaflet:

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