Nifuroxazide gedeon richter

Package leaflet: Information for the patient

NIFUROXAZIDE GEDEON RICHTER, 100 mg, coated tablets
Nifuroxazidum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please contact your pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement or if you feel worse, consult your doctor.

Leaflet 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 action in the intestinal lumen against certain bacterial species.
Nifuroxazide Gedeon Richter does not destroy the 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 extensively metabolized. The portion of nifuroxazide not absorbed in the gastrointestinal tract is excreted unchanged in the faeces.
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 Nifuroksazyd Gedeon Richter

When not to take Nifuroksazyd Gedeon Richter

• If the patient has been diagnosed with hypersensitivity (allergy) to nifuroxazide or any of the other ingredients of this medicine (listed in section 6). Allergic reactions may include swelling of the face, lips, tongue or difficulty breathing (if such symptoms occur, contact a doctor immediately).
• Do not use in children under 7 years of age, as children of this age may have difficulty swallowing the tablet.

Warnings and precautions

• If diarrhea persists for more than 3 days despite treatment with Nifuroksazyd Gedeon Richter, contact a doctor. The doctor will perform tests to determine the cause of symptoms and decide on further treatment.
• If allergic reactions occur, such as rash or itching, discontinue use of Nifuroksazyd Gedeon Richter immediately.
• Nifuroksazyd Gedeon Richter should be used together with a diet excluding juices, raw vegetables and fruits, spicy and hard-to-digest foods, as well as ice creams and cold drinks. It is recommended to eat baked meat and rice.
• During treatment for diarrhea, it is essential to continuously replenish fluids (orally or intravenously), depending on the patient's general condition (average daily water 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.
• As a precaution, Nifuroksazyd Gedeon Richter should not be administered during pregnancy and breastfeeding.

Nifuroksazyd Gedeon Richter and other medicines
Nifuroksazyd Gedeon Richter reduces the absorption of many drugs from the gastrointestinal tract.
If the patient is taking other medicines, they should consult a doctor before starting treatment with Nifuroksazyd Gedeon Richter.
Nifuroksazyd Gedeon Richter with food and drink
Ensure adequate food intake during diarrhea, avoiding certain products, especially juices, raw vegetables and fruits, spicy and hard-to-digest meals, as well as ice creams and cold drinks. It is recommended to eat baked meat and rice.
Drinking alcohol during treatment with Nifuroksazyd Gedeon Richter may cause acute and severe intolerance reactions (so-called disulfiram-like reactions).
Pregnancy and breastfeeding
As a precaution, Nifuroksazyd Gedeon Richter should not be administered during pregnancy and breastfeeding. In women of childbearing age, Nifuroksazyd Gedeon Richter may be used only if effective contraception is used.
Driving and operating machinery
Nifuroksazyd Gedeon Richter has no effect on the ability to drive, operate machinery or handle tools.

3. How to take Nifuroksazyd Gedeon Richter

• The usual dose for adults and children aged 7 years and older is 2 tablets taken 4 times daily, every 6 hours.
• Nifuroksazyd Gedeon Richter is taken orally. The tablets should be swallowed whole with an adequate amount of liquid, for example a glass of water. The tablets must not be chewed or crushed.
• 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 consulting a doctor. During treatment of diarrhoea with Nifuroksazyd Gedeon Richter, continuous oral rehydration is necessary; therefore, large amounts of fluids should be consumed, preferably water, sweetened or flavoured drinks (average water intake for an adult patient - 2 litres per day), to compensate for fluid loss caused by diarrhoea. In cases of severe and prolonged diarrhoea, severe vomiting, or lack of appetite, 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 Nifuroksazyd Gedeon Richter than recommended
If you take more Nifuroksazyd Gedeon Richter than recommended, contact a doctor immediately.
Show the doctor the tablet packaging.
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 doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
No severe, life-threatening side effects have been observed after taking Nifuroksazyd Gedeon Richter, except for 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 side effects may occur:

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

Additionally, the following side effects 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 available data), the following may occur:

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

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department for Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warszawa
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 authorisation holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Nifuroksazyd Gedeon Richter

Keep this medicine 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 word "Exp:". The expiry date refers to the last day of the specified month.
Do not store above 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines no longer in use. This helps protect the environment.

6. Contents of the package and other information

What Nifuroksazyd Gedeon Richter contains
The active substance is nifuroxazide. Each coated tablet contains 100 mg of nifuroxazide.
The other ingredients are: colloidal anhydrous silica, potato starch, gelatin, talc,
magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol 20000, quinoline yellow (E 104).
What Nifuroksazyd Gedeon Richter looks like and contents of the pack
Nifuroksazyd Gedeon Richter is in the form of yellow, round, biconvex coated tablets.

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
[email protected]
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