Nifuroxazide gedeon richter

Package leaflet: Information for the patient

NIFUROXAZIDE GEDEON RICHTER, 200 mg,
hard capsules
Nifuroxazidum
Please read carefully the entire leaflet before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in the 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, consult your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If symptoms do not improve or worsen, contact your doctor.

Table of contents

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. Contents of the pack and other information

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

Nifuroxazide Gedeon Richter is an antibacterial medicine. It exerts a local effect in the intestinal lumen against certain bacterial species.
Nifuroxazide Gedeon Richter does not destroy the normal, non-pathogenic intestinal flora. 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 the feces.
Nifuroxazide Gedeon Richter is indicated for the treatment of the following conditions:

• Acute and chronic bacterial diarrhoea.
• Other disorders associated with diarrhoea.

2. Important information before using the medicine Nifuroksazyd Gedeon Richter

When not to use the medicine Nifuroksazyd Gedeon Richter

Warnings and precautions

• If diarrhoea persists for more than 3 days despite treatment with Nifuroxasid Gedeon Richter, consult a physician. The physician will perform tests to determine the cause of symptoms and establish further treatment.
• If allergic reactions occur with symptoms such as rash or itching, discontinue use of Nifuroxasid Gedeon Richter.
• Nifuroxasid Gedeon Richter should be used in conjunction with a diet excluding fruit juices, raw vegetables and fruits, spicy and hard-to-digest foods, as well as ice cream and cold beverages.
• During treatment for diarrhoea, it is essential to continuously replenish fluids (orally or intravenously), depending on the patient's general condition (average daily fluid intake for an adult patient – 2 litres), in order to compensate for fluid loss caused by diarrhoea. In cases of severe and prolonged diarrhoea, severe vomiting, or refusal to eat, intravenous rehydration should be considered.
• As a precautionary measure, Nifuroxasid Gedeon Richter should not be administered during pregnancy and breastfeeding.

Nifuroxasid Gedeon Richter and other medicines
Nifuroxasid Gedeon Richter reduces the absorption of many drugs from the gastrointestinal tract.
If the patient is taking other medicines, they should consult a physician before starting treatment with Nifuroxasid Gedeon Richter.

Nifuroxasid Gedeon Richter with food and drink
Appropriate dietary intake should be ensured during episodes of diarrhoea, avoiding certain products, particularly 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.
Consumption of alcohol during treatment with Nifuroxasid Gedeon Richter may cause acute and dangerous intolerance reactions (so-called disulfiram-like reactions).

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

Driving and operating machinery
Nifuroxasid Gedeon Richter has no influence on the ability to drive, operate machinery, or use tools.

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

3. How to use Nifuroksazyd Gedeon Richter

• The usual dose for adults and children aged 7 years and older is 1 capsule taken 4 times daily, every 6 hours.

• Nifuroksazyd Gedeon Richter is administered orally. The capsules should be swallowed whole, accompanied by an adequate amount of liquid, for example a glass of water.

• If symptoms worsen or do not improve after 3 days, consult a doctor.

• Nifuroksazyd Gedeon Richter should not be used for longer than 3 days without medical advice. During treatment of diarrhoea with Nifuroksazyd Gedeon Richter, it is essential to maintain constant hydration. Large amounts of fluids should therefore be consumed, preferably water, sweetened or flavoured drinks (average daily water intake for an adult patient – 2 litres), in order to replace fluids lost due to diarrhoea. 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
If you take more than the recommended dose of Nifuroksazyd Gedeon Richter, seek medical advice immediately. Show the doctor the packaging of the capsules.
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 stop treatment before the end of 3 days, even if you feel better.
If you have any further doubts regarding 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 will experience them.
Severe, life-threatening adverse reactions following administration of the medicine
Nifuroxazide Gedeon Richter have not been observed, with the exception of one case of granulocytopenia (reduction in the number of a certain type of white blood cells - granulocytes).
In individual cases of hypersensitivity to nifuroxazide, the following adverse reactions may occur:

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

Additionally, the following adverse reactions may rarely occur (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 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 may 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

Nifuroksazyd Gedeon Richter does not require any special storage conditions.
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 blisters following:
"Exp:". The expiry date refers to the last day of the stated month.
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 Gedeon Richter contains

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

What Nifuroksazyd Gedeon Richter looks like and contents of the pack
Nifuroksazyd Gedeon Richter is in the form of yellow hard gelatin capsules.
Pack: a cardboard box containing 12 capsules.

Marketing Authorisation 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 further 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
[email protected]
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