Nifuroksazid 200 Hasco

Leaflet attached to the packaging: patient information

NIFUROXAZIDE 200 HASCO

200 mg, coated tablets
Nifuroxazidum

Please read the contents of the leaflet carefully 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 a doctor, pharmacist, or nurse.

• Please keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 3 days or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Nifuroxazide 200 Hasco and what is it used for
• 2. Important information before using Nifuroxazide 200 Hasco
• 3. How to use Nifuroxazide 200 Hasco
• 4. Possible side effects
• 5. How to store Nifuroxazide 200 Hasco
• 6. Package contents and other information

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

Nifuroxazide exhibits antibacterial activity against most bacteria that cause intestinal infections. The medicine is effective against Gram-positive bacteria of the Staphylococcusand Streptococcusspecies, as well as Gram-negative microorganisms ( Salmonella, Shigella, Klebsiella, Escherichia). It does not affect bacteria of the Proteus, Pseudomonas, Providentiaspecies. It does not disrupt the normal microbiological balance of the gastrointestinal tract.
Nifuroxazide acts quickly, its high concentration occurs in the intestinal lumen, which conditions its antibacterial effect. It does not have a general effect and is quickly eliminated from the body.

Indications for use

Nifuroxazide 200 Hasco is used in acute or chronic diarrhea in the course of bacterial gastrointestinal infections.

2. Important information before using Nifuroxazide 200 Hasco

When not to use Nifuroxazide 200 Hasco:

• if the patient is allergic to nifuroxazide, 5-nitrofuran derivatives, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting to use Nifuroxazide 200 Hasco, you should discuss it with your doctor, pharmacist, or nurse.
As a precaution, Nifuroxazide 200 Hasco should not be administered during pregnancy and breastfeeding.
During treatment, it is necessary to supplement fluids and electrolytes.
If diarrhea persists after 2 or 3 days of treatment or worsens during the use of the medicine, you should immediately contact your doctor.

Nifuroxazide 200 Hasco and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

Nifuroxazide 200 Hasco with food, drink, and alcohol

The medicine should be used simultaneously with a strict diet excluding juices, raw vegetables and fruits, spicy and hard-to-digest foods.
Consuming alcohol during treatment may cause a reaction characterized by increased diarrhea, vomiting, abdominal pain.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before using this medicine.
As a precaution, Nifuroxazide 200 Hasco should not be administered during pregnancy and breastfeeding. In women of childbearing age, Nifuroxazide 200 Hasco can only be used if they are using effective contraception.

Driving and operating machinery

The medicine has no effect or a negligible effect on the ability to drive and operate machinery.

The medicine contains quinoline yellow, lake (E 104), orange yellow, lake (E 110), and sodium

The medicine may cause allergic reactions.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to use Nifuroxazide 200 Hasco

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor, pharmacist, or nurse. If you have any doubts, you should consult your doctor, pharmacist, or nurse.
The medicine is administered orally.
The recommended dose is:
Adults: 800 mg per day in 2-4 divided doses.
Children over 6 years: 600 to 800 mg per day in 2-4 divided doses.
Without consulting a doctor, do not use for more than 3 days.

Using a higher dose of Nifuroxazide 200 Hasco than recommended

In the event of intentional or accidental ingestion of large amounts of the medicine, you should induce vomiting and consult a doctor.

Missing a dose of Nifuroxazide 200 Hasco

A missed dose should be taken as soon as possible. Do not take a double dose to make up for a missed dose.
If you have any further doubts about using this medicine, you should consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Nifuroxazide is usually well-tolerated. Allergic reactions may occur, characterized by skin allergic reactions.
Reporting side effects
If you experience any side effects, including any possible side effects not listed in the leaflet, you should inform your doctor or pharmacist, or nurse. 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.: 22 49-21-301, fax: 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 gather more information on the safety of this medicine.

5. How to store Nifuroxazide 200 Hasco

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C. Store 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 specified month.
Medicines should not be disposed of via wastewater or household waste containers. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Nifuroxazide 200 Hasco contains

• The active substance of the medicine is nifuroxazide ( Nifuroxazidum). One coated tablet contains 200 mg of nifuroxazide.
• The other ingredients (excipients) are: potato starch, povidone, magnesium stearate, and coating (Opadry II Yellow 85F22064) with the composition: 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 Nifuroxazide 200 Hasco looks like and what the package contains

The medicine is in the form of tablets with a shape of a convex disk, yellow in color, with a uniform surface, with a one-sided engraving with the logo of Hasco-Lek company.
One package of the medicine contains 12 coated tablets in a cardboard box.

Marketing authorization holder and manufacturer

“HASCO-LEK” Pharmaceutical Company S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E

Information about the medicine

tel.: 22 742 00 22
e-mail: [email protected]

Date of the last update of the leaflet: