Nifuroksazid Hasco

Package Leaflet: Information for the Patient

NIFUROXAZID HASCO

100 mg, film-coated tablets
Nifuroxazidum

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the package leaflet for the patient, or as directed by a doctor, pharmacist, or nurse.

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

Table of Contents of the Leaflet

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

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

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

Indications for Use

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

2. Important Information Before Taking Nifuroksazyd Hasco

When Not to Take Nifuroksazyd Hasco:

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

Warnings and Precautions

Before starting to take Nifuroksazyd Hasco, the patient should discuss it with their doctor, pharmacist, or nurse.
As a precaution, Nifuroksazyd Hasco should not be given during pregnancy and breastfeeding.
During treatment, it is necessary to replenish fluids and electrolytes.
If diarrhea persists after 2-3 days of treatment or if diarrhea worsens during treatment, the patient should contact their doctor immediately.

Children

The medicine should not be used in children under 6 years of age.

Nifuroksazyd Hasco and Other Medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take.

Nifuroksazyd Hasco with Food, Drink, and Alcohol

The medicine should be taken 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, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
As a precaution, Nifuroksazyd Hasco should not be given during pregnancy and breastfeeding. In women of childbearing age, Nifuroksazyd Hasco can only be used if they are using effective contraception.

Driving and Operating Machines

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

The Medicine Contains Aluminum Lake Quinoline Yellow (E 104), Aluminum Lake Orange Yellow (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 Take Nifuroksazyd Hasco

This medicine should always be taken exactly as described in the package leaflet for the patient, or as directed by a doctor, pharmacist, or nurse. If in doubt, the patient should consult their doctor, pharmacist, or nurse.
The medicine is taken orally.
The recommended dose is:
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.
Without consulting a doctor, the medicine should not be taken for more than 3 days.

Taking a Higher Dose of Nifuroksazyd Hasco Than Recommended

In case of intentional or accidental ingestion of large amounts of the medicine, the patient should induce vomiting and consult their doctor.

Missing a Dose of Nifuroksazyd Hasco

A missed dose should be taken as soon as possible. A double dose should not be taken to make up for a missed dose.
If there are any further doubts about taking this medicine, the patient should consult their doctor, pharmacist, or nurse.

4. Possible Side Effects

Like all medicines, Nifuroksazyd Hasco can cause side effects, although not everybody gets them.
Nifuroksazyd is usually well-tolerated. Allergic reactions may occur, characterized by skin allergic reactions.
Reporting Side Effects
If any side effects occur, including any possible side effects not listed in the leaflet, the patient should tell their doctor, 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, more information can be gathered on the safety of the medicine.

5. How to Store Nifuroksazyd Hasco

The medicine should be stored out of sight and reach of children.
Store in the original packaging, at a temperature below 25°C.
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. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package Contents and Other Information

What Nifuroksazyd Hasco Contains

• The active substance of the medicine is nifuroksazyd ( Nifuroxazidum). One film-coated tablet contains 100 mg of nifuroksazyd.
• The other ingredients (excipients) are: potato starch, povidone, magnesium stearate, and coating (Opadry II HP 85F22064 Yellow) with the composition: polyvinyl alcohol, macrogol 3350, aluminum lake quinoline yellow (E 104), talc, titanium dioxide (E 171), aluminum lake orange yellow (E 110), aluminum lake indigo carmine (E 132).

What Nifuroksazyd Hasco Looks Like and What the Package Contains

The medicine is in the form of tablets with a convex shape on both sides, yellow in color, with a smooth and uniform surface.
One package of the medicine contains 24 film-coated tablets in a cardboard box.

Marketing Authorization Holder and Manufacturer

“PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK” S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E

Medicine Information

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

Date of Last Update of the Leaflet: