Nifuroxazide hasco

Package leaflet: information for the patient

NIFUROKSAZYD HASCO
220 mg/5 ml, oral suspension
Nifuroxazidum
Please read carefully the entire leaflet before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

1. What is Nifuroksazyd Hasco and for what is it used
2. Important information before using Nifuroksazyd Hasco
3. How to use Nifuroksazyd Hasco
4. Possible adverse reactions
5. How to store Nifuroksazyd Hasco
6. Contents of the pack and other information

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

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

2. Important information before using Nifuroksazyd Hasco

When not to use Nifuroksazyd Hasco:

• if the patient is allergic to nifuroxazide, 5-nitrofuran derivatives, or any of the other ingredients of this medicine (listed in section 6),
• in premature infants and newborns (up to 1 month of age).

Warnings and precautions
Before starting treatment with Nifuroksazyd Hasco, consult your doctor, pharmacist, or nurse.
As a precautionary measure, Nifuroksazyd Hasco should not be administered during pregnancy or breastfeeding.
During treatment, it is essential to replenish fluids and electrolytes.
If diarrhea persists after 2 or 3 days of treatment, or if diarrhea worsens during treatment, contact your doctor immediately.

Nifuroksazyd Hasco with other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Taking Nifuroksazyd 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.
Consuming alcohol during treatment may cause a reaction characterized by severe diarrhea, vomiting, and abdominal pain.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
As a precautionary measure, Nifuroksazyd Hasco should not be used during pregnancy or breastfeeding. In women of childbearing age, Nifuroksazyd Hasco should only be used if effective contraception is being applied.

Driving and operating machinery
This medicine does not impair psycho-physical performance or the ability to drive mechanical vehicles or operate machinery in motion.

Nifuroksazyd Hasco contains: methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate, non-crystallizing liquid sorbitol (E 420), sodium, ethanol (from flavoring), and propylene glycol (E 1520)
This medicine may cause allergic reactions (including delayed-type 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 the patient (or their child) has previously been diagnosed with intolerance to certain sugars or hereditary fructose intolerance—a rare genetic disorder in which the body cannot break down fructose—the patient should consult a doctor before taking the medicine or giving it to a child.
When the dose of sorbitol ingested from a 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, meaning this medicine is considered "sodium-free".
This medicine contains 1 mg of alcohol (ethanol) in each 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 produce noticeable effects.
The medicine contains 139 mg of propylene glycol in each 5 ml of suspension. When the dose of propylene glycol ingested from a medicinal product exceeds 50 mg/kg body weight per day, the following warnings should be considered.
Before administering this medicine to a child under 5 years of age, consult a doctor or pharmacist, especially if the child is taking other medicines containing propylene glycol or alcohol.
Women who are pregnant or breastfeeding should not take this medicine without medical advice. The doctor may decide to perform additional tests in such patients.
Patients with impaired liver or kidney function should not take this medicine without medical advice. The doctor may decide to perform additional tests in such patients.

3. How to use Nifuroksazyd Hasco

This medicine should always be used according to the instructions given by your doctor or pharmacist. If you have any doubts,
you should consult your doctor or pharmacist.
The medicine is taken orally. Before use, shake vigorously to obtain a uniform suspension.
Recommended dose:
Children 1-30 months: from 220 mg to 660 mg, i.e. from 1 measuring spoon (5 ml) to 3 measuring spoons (15 ml) per day in
2-3 divided doses.
Children over 30 months: 660 mg, i.e. 3 measuring spoons (15 ml) per day in 3 divided doses.
Do not administer to premature infants and newborns (up to 1 month of age).
Do not use for longer than 7 days.
A measuring spoon (5 ml) is provided with the packaging.
Use of a higher than recommended dose of Nifuroksazyd Hasco
If large quantities of the medicine are taken intentionally or accidentally, induce vomiting and
seek immediate medical attention.
Missed dose of Nifuroksazyd 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.

4. Possible adverse effects

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

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse.
Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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 effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store the medicine Nifuroksazyd Hasco

Keep the medicine out of the sight and reach of children.
Store in the original tightly closed container, 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 stated month.
Medicines must 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. Package contents and other information

What Nifuroxazide Hasco contains

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

What Nifuroxazide Hasco looks like and contents of the pack
The medicine is a yellow suspension.
One package consists of a 100 ml bottle containing not less than 100 g of suspension, in a cardboard box with a dosing spoon.
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]