Package leaflet: Information for the patient

NIFUROKSAZID 200 HASCO
200 mg, coated tablets
Nifuroxazidum
Please read carefully all the information in this leaflet before taking the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
the physician, pharmacist, or nurse.

Keep this leaflet, so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
If there is no improvement after 3 days, or if you feel worse, consult your doctor.

Table of contents

What is Nifuroksazid 200 Hasco and what is it used for
Important information before taking Nifuroksazid 200 Hasco
How to take Nifuroksazid 200 Hasco
Possible side effects
How to store Nifuroksazid 200 Hasco
Contents of the pack and other information

1. What is Nifuroksazid 200 Hasco and what is it used for

Nifuroxazid exhibits antibacterial activity against most bacteria causing intestinal infections. The drug acts on Gram-positive cocci of the genera Staphylococcus and Streptococcus, as well as on Gram-negative microorganisms (Salmonella, Shigella, Klebsiella, Escherichia). It has no effect on bacteria of the genera Proteus, Pseudomonas, Providentia. It does not disturb the normal microbiological balance of the gastrointestinal tract.
Nifuroxazid acts rapidly, achieving high concentrations in the intestinal lumen, which ensures its antibacterial effect. It does not exert systemic effects and is rapidly eliminated from the body.
Indications
Nifuroksazid 200 Hasco is indicated in acute or chronic diarrhoea due to bacterial infections of the gastrointestinal tract.

2. Important information before using Nifuroksazyd 200 Hasco

When not to use Nifuroksazyd 200 Hasco:

if the patient is allergic to nifuroxazide, nitrofuran derivatives, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Nifuroksazyd 200 Hasco, discuss it with your doctor,
pharmacist, or nurse.
As a precaution, Nifuroksazyd 200 Hasco should not be administered during
pregnancy and breastfeeding.
During treatment, it is necessary to replenish fluids and electrolytes.
If diarrhoea persists after 2 or 3 days of treatment or if diarrhoea worsens during
treatment, contact your doctor immediately.
Nifuroksazyd 200 Hasco and other medicines
Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines the patient plans to use.
Nifuroksazyd 200 Hasco with food, drink and alcohol
This medicine should be taken while following a strict diet excluding fruit juices, raw vegetables and fruits, spicy and hard-to-digest foods.
Consumption of alcohol during treatment may cause a reaction characterised by severe diarrhoea, vomiting, and abdominal pain.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
As a precaution, Nifuroksazyd 200 Hasco should not be administered during
pregnancy and breastfeeding. In women of childbearing age, Nifuroksazyd 200 Hasco may be used only if effective contraception is used.
Driving and operating machinery
This medicine has no effect or has negligible effect on the ability to drive and operate machinery.
The medicine contains quinoline yellow, lac (E 104), sunset yellow, lac (E 110), and sodium
The medicine may cause allergic reactions.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Nifuroksazyd 200 Hasco

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor, pharmacist, or nurse. If in doubt, consult a doctor, pharmacist, or nurse.
This medicine is taken orally.
Recommended dose:
Adults: 800 mg per day in 2–4 divided doses.
Children over 6 years of age: 600 to 800 mg per day in 2–4 divided doses.
Do not use for longer than 3 days without consulting a doctor.
Taking more Nifuroksazyd 200 Hasco than recommended
In case of intentional or accidental ingestion of large quantities of the medicine, induce vomiting and seek medical advice immediately.
Missing a dose of Nifuroksazyd 200 Hasco
If a dose is missed, take it as soon as possible. Do not take a double dose to make up for the missed dose.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Nifuroksazyd is generally well tolerated. Hypersensitivity reactions may occur, manifesting as
allergic skin reactions.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. 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,
tel.: 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 provide more information on the safety of the medicine.

5. How to store Nifuroksazyd 200 Hasco

Keep this medicine out of sight and reach of children.
Store below 25°C. Keep in the original packaging.
Do not use this medicine after the expiry date stated on the packaging. 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 in use. This will help protect the environment.

6. Contents of the package and other information

What Nifuroksazyd 200 Hasco contains

The active substance is nifuroxazide (Nifuroxazidum). One coated tablet contains 200 mg of nifuroxazide.
The other ingredients (excipients) are: potato starch, povidone, magnesium stearate and a coating (Opadry II Yellow 85F22064) composed of: polyvinyl alcohol, macrogol 3350, quinoline yellow, lake (E 104); talc, titanium dioxide (E 171), orange yellow, lake (E 110); indigo carmine, lake (E 132).

What Nifuroksazyd 200 Hasco looks like and contents of the pack
Nifuroksazyd 200 Hasco is a yellow, biconvex, circular tablet with a uniform surface, featuring the Hasco-Lek company logo engraved on one side.
One pack contains 12 coated tablets in a cardboard box.

Marketing Authorisation Holder and Manufacturer
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E

Information on the medicinal product
tel.: 22 742 00 22
e-mail: [email protected]