Nifuroxazide polfarmex

Package leaflet: Information for the user

NIFUROKSAZID POLFARMEX, 200 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. 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 there is no improvement within 3 days or if your condition worsens, contact your doctor.

Table of contents

1. What Nifuroksazyd Polfarmex is and what it is used for
2. What you need to know before taking Nifuroksazyd Polfarmex
3. How to take Nifuroksazyd Polfarmex
4. Possible side effects
5. How to store Nifuroksazyd Polfarmex
6. Contents of the pack and other information

1. What Nifuroksazyd Polfarmex is and what it is used for

Nifuroksazyd Polfarmex is a derivative of 5-nitrofuran and an antibacterial agent. It exerts local action within the intestinal lumen against certain bacterial species.
Nifuroksazyd Polfarmex does not destroy non-pathogenic bacteria normally present in the gastrointestinal tract. It does not induce the development of bacterial strains resistant to its action.
After oral administration, the product is partially absorbed (10–20%) from the gastrointestinal tract and is extensively metabolized, with the main circulating components being metabolites.
Nifuroksazyd Polfarmex is indicated for the treatment of acute and chronic bacterial diarrhoea in adults and children above 7 years of age.

2. Information before using Nifuroksazyd Polfarmex

When not to use Nifuroksazyd Polfarmex

• If the patient is allergic to nifuroxazide, derivatives of 5-nitrofuran, or any of the other ingredients of this medicine (listed in section 6). Allergic reactions may manifest as rash, facial swelling, swelling of the lips, tongue or throat, difficulty breathing, confusion, pallor, rapid breathing, weakness and fainting (if such symptoms occur, contact a doctor immediately).
• Do not use in children under 7 years of age, as children in this age group may have difficulty swallowing the tablet.

Warnings and precautions

• If diarrhoea persists after 2 or 3 days of treatment, or if diarrhoea worsens during treatment, contact a doctor immediately.
• If an allergic reaction occurs with symptoms such as rash, itching, swelling, confusion, pallor, rapid breathing, weakness or fainting, discontinue use of Nifuroksazyd Polfarmex immediately.
• Maintain adequate fluid intake with sweet or salty fluids to replace fluids lost due to diarrhoea (average daily water requirement for an adult is 2 litres).
• Continue to eat meals throughout the duration of diarrhoea:
  • excluding certain foods – particularly raw vegetables, fruits, leafy greens, spicy dishes, as well as frozen foods and cold beverages;
  • grilled meat and rice are recommended;
  • alcohol should not be consumed during treatment with nifuroxazide.
• As a precautionary measure, Nifuroksazyd Polfarmex should not be administered during pregnancy or breastfeeding.

In case of severe and prolonged diarrhoea, severe vomiting or loss of appetite,
seek medical advice, as intravenous rehydration may be necessary.
Before starting treatment with Nifuroksazyd Polfarmex, discuss this with your doctor or
pharmacist.
Nifuroksazyd Polfarmex and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines you plan to take.
Nifuroksazyd Polfarmex reduces the absorption of many drugs from the gastrointestinal tract. Therefore,
other oral medicines should not be taken simultaneously during treatment with Nifuroksazyd Polfarmex.
Taking Nifuroksazyd Polfarmex with food, drinks and alcohol
See "Warnings and precautions" and section 3.
Consuming alcohol during treatment with Nifuroksazyd Polfarmex may cause acute and potentially serious intolerance reactions (so-called disulfiram-like reactions).
Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine. As a precautionary measure, Nifuroksazyd Polfarmex should not be used during pregnancy or breastfeeding. In women of childbearing potential, Nifuroksazyd Polfarmex should only be used if effective contraception is being employed.
Driving and operating machinery
Nifuroksazyd Polfarmex has no effect on the ability to drive or operate machinery.
Nifuroksazyd Polfarmex contains 3.84 mg of monohydrate lactose per coated tablet.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should
consult a doctor before taking this medicine. The medicine contains 0.00384 g of lactose (0.00192 g
of glucose and 0.00192 g of galactose) per coated tablet. This should be taken into account in patients
with diabetes.

3. How to use Nifuroksazyd Polfarmex

This medicine should always be taken exactly as described in this patient information leaflet, or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The recommended dose is:
Adults: 800 mg per day in 2–4 divided doses.
Children over 7 years of age: 600–800 mg per day in 2–4 divided doses.
Do not use Nifuroksazyd Polfarmex for longer than 3 days without consulting a doctor. If symptoms worsen or do not improve after 3 days, contact your doctor. Do not use for longer than 7 days.
This medicine is for oral use. Tablets should be swallowed whole with an adequate amount of liquid (a glass of water). Do not chew or crush the tablets.
Do not use Nifuroksazyd Polfarmex for longer than 3 days without consulting a doctor.
If symptoms worsen or do not improve after 3 days, contact your doctor.
During treatment of diarrhoea with Nifuroksazyd Polfarmex, fluid replacement is essential (see "Warnings and precautions" in section 2).
Taking more Nifuroksazyd Polfarmex than recommended
If you take more than the recommended dose, contact your doctor or pharmacist immediately. Show the doctor the medicine packaging.
If you forget to take Nifuroksazyd Polfarmex
If you miss a dose, take it as soon as you remember, unless it is almost time for the next dose.
Do not take a double dose to make up for a missed dose.
Stopping Nifuroksazyd Polfarmex treatment
Do not stop treatment before 3 days have passed, even if you feel 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.
You should contact your doctor immediately if any allergic reactions occur:

• allergic reactions, for example skin reactions; rash, urticaria, angioedema (manifesting as swelling of the face, lips, tongue, shortness of breath);
• anaphylactic shock (manifesting as confusion, pale skin, rapid breathing, weakness, and fainting).

Additionally, the following adverse reactions may occur:
Rare (affects fewer than 1 in 1,000 patients):
rash;
skin blisters.
Unknown frequency (cannot be estimated from available data):
granulocytopenia (reduced number of a certain type of white blood cells – granulocytes);
nodular prurigo in the course of contact allergy to nifuroxazide;
abdominal pain;
nausea;
worsening of diarrhea.
In case of mild abdominal pain, nausea, and diarrhea, there is no need for specific treatment or discontinuation of nifuroxazide. However, if symptoms are severe, the medicine should be discontinued. In such cases, nitrofuran derivatives should be avoided in the future.
Reporting of adverse reactions
If any adverse reactions occur, including any 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: (22) 49 21 301
Fax: (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 Polfarmex

Keep this medicine out of sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date stated on the carton and blister
after: "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 will help
protect the environment.

6. Contents of the pack and other information

What Nifuroksazyd Polfarmex contains
The active substance is nifuroxazid (Nifuroxazidum).
One tablet contains 200 mg of nifuroxazid.
The other ingredients are: potato starch, povidone K-25, magnesium stearate.
Coating: monohydrate lactose, hypromellose 6cP, titanium dioxide (E 171), macrogol 6000, yellow
iron oxide (E 172).
What Nifuroksazyd Polfarmex looks like and contents of the pack
Nifuroksazyd Polfarmex – coated tablet, yellow in colour, round, biconvex, with a nominal diameter of
10 mm, free from spots and damage.
The pack contains 20 or 30 coated tablets.
Marketing Authorisation Holder and Manufacturer
Polfarmex S.A.
ul. Józefów 9
99-300 Kutno
Poland
Tel.: 24 357 44 44
Fax: 24 357 45 45
e-mail: [email protected]