Nifuroksazid Hasco

Package Leaflet: Information for the Patient

NIFUROKSAZYD HASCO

220 mg/5 ml, oral suspension
Nifuroxazidum

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

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. Contents of the pack and other information

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

Nifuroksazyd has antibacterial activity against most bacteria that cause intestinal infections. The medicine works on Gram-positive bacteria of the genus Staphylococcus and Streptococcusand Gram-negative microorganisms (Salmonella, Shigella, Klebsiella, Escherichia). It does not work on bacteria of the genus Proteus, Pseudomonas, Providentia. It does not disrupt the normal microbiological balance of the digestive tract. The medicine works quickly, its high concentration occurs in the intestine, which conditions the antibacterial effect. It does not have a general effect and is quickly excreted from the body.

Indications for Use

Nifuroksazyd Hasco oral suspension is used in acute or chronic diarrhea in the course of bacterial infections of the digestive tract.

2. Important Information Before Taking Nifuroksazyd Hasco

When Not to Take Nifuroksazyd Hasco:

• in premature infants and newborns (up to 1 month).

Warnings and Precautions

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

Nifuroksazyd Hasco and Other Medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take.

Taking 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 with increased diarrhea, vomiting, abdominal pain.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before taking this medicine.
As a precaution, Nifuroksazyd Hasco should not be taken 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 does not cause impairment of psychophysical abilities, the ability to drive vehicles, and operate machinery.

Nifuroksazyd Hasco Contains:

The medicine may cause allergic reactions (possible late reactions).
The medicine contains 907.5 mg of non-crystallizing liquid sorbitol in each 5 ml of suspension.
Sorbitol is a source of fructose. If you have previously been diagnosed with intolerance to some sugars or have been diagnosed with hereditary fructose intolerance, a rare genetic disease in which the body does not break down fructose, you should contact your doctor before taking the medicine or giving it to your child.
In case the dose of sorbitol taken with the medicinal product exceeds 140 mg/kg body weight per day, sorbitol may cause gastrointestinal discomfort and may have a mild laxative effect.
The medicine contains less than 1 mmol (23 mg) of sodium per 5 ml, which means the medicine is considered "sodium-free".
This medicine contains 1 mg of alcohol (ethanol) per 5 ml. The amount of alcohol in 5 ml of this medicine is equivalent to less than 1 ml of beer or 1 ml of wine. The small amount of alcohol in this medicine will not have noticeable effects.
The medicine contains 139 mg of propylene glycol per 5 ml of suspension. If the dose of propylene glycol taken with the medicinal product exceeds 50 mg/kg body weight per day, the following warnings should be taken into account.
Before giving the medicine to a child under 5 years of age, consult a doctor or pharmacist, especially if the child is taking other medicines that contain propylene glycol or alcohol.
Pregnant or breastfeeding women should not take this medicine without a doctor's recommendation. The doctor may decide to perform additional tests on such patients.
Patients with liver or kidney function disorders should not take this medicine without a doctor's recommendation. The doctor may decide to perform additional tests on such patients.

3. How to Take Nifuroksazyd Hasco

Take this medicine always as directed by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist.
Take the medicine orally. Before use, shake vigorously to obtain a uniform suspension.
The recommended dose is:
Children 1-30 months: from 220 mg to 660 mg, i.e., from 1 measuring cup (5 ml) to 3 measuring cups (15 ml) per day in 2-3 divided doses.
Children over 30 months: 660 mg, i.e., 3 measuring cups (15 ml) per day in 3 divided doses.
Do not give to premature infants and newborns (up to 1 month).
Do not take for more than 7 days.
A measuring cup (5 ml) is attached to the package.

Taking a Higher Dose of Nifuroksazyd Hasco Than Recommended

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

Missing a Dose of Nifuroksazyd Hasco

Take the missed dose as soon as possible. Do not take a double dose to make up for the missed dose.

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, manifesting as skin allergic reactions.
Reporting Side Effects
If you experience any side effects, including those not listed in this leaflet, tell your 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, you can help provide more information on the safety of this medicine.

5. How to Store Nifuroksazyd Hasco

Keep the medicine out of the sight and reach of children.
Store in the original package, at a temperature below 25°C.
Do not use this medicine after the expiry date stated on the package. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the Pack and Other Information

What Nifuroksazyd Hasco Contains

• The active substance of the medicine is nifuroksazyd (Nifuroxazidum). 1 measuring cup (5 ml) contains 220 mg of nifuroksazyd.
• The other ingredients (excipients) are: methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate, propylene glycol (E 1520), carbomer, sodium saccharin, sodium hydroxide, citric acid monohydrate, non-crystallizing liquid sorbitol (E 420), glycerol, banana flavor (contains propylene glycol E 1520 and ethanol), and purified water.

What Nifuroksazyd Hasco Looks Like and What the Pack Contains

The medicine is a yellow suspension.
One pack of the medicine consists of a 100 ml bottle containing not less than 100 g of suspension, in a cardboard box with a measuring cup for administering the medicine.

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
email: [email protected]

Date of Last Update of the Leaflet: