Zifurax Iunior

Leaflet attached to the packaging: patient information

ZYFURAX JUNIOR, 100 mg, coated tablets

Nifuroxazide

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 advised by
the doctor, pharmacist, or nurse.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, the pharmacist should be consulted.
• 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 Zyfurax Junior and what is it used for
• 2. Important information before using Zyfurax Junior
• 3. How to use Zyfurax Junior
• 4. Possible side effects
• 5. How to store Zyfurax Junior
• 6. Package contents and other information

1. What is Zyfurax Junior and what is it used for

The active substance of Zyfurax Junior is nifuroxazide. It has antibacterial effects against most bacteria that cause intestinal infections. It acts on Gram-positive cocci of the Staphylococcusand Streptococcusgenera, as well as Gram-negative microorganisms (Salmonella, Shigella,
Klebsiella, Escherichia). It does not act on bacteria of the Proteus, Pseudomonas, Providentiagenera.
It does not disrupt the normal microbiological balance of the gastrointestinal tract.

Indications for use

Zyfurax Junior is used in acute or chronic diarrhea in the course of bacterial gastrointestinal infections.

2. Important information before using Zyfurax Junior

When not to use Zyfurax Junior:

• 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 Zyfurax Junior, the patient should discuss it with their doctor, pharmacist, or
nurse.
During treatment, it is necessary to replenish fluids and electrolytes.
If diarrhea persists after 2 or 3 days of treatment or worsens during the use of the medicine, the patient should immediately contact their doctor.
The patient should consult their doctor, even if the above warnings concern situations that occurred
in the past.

Zyfurax Junior and other medicines

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

Using Zyfurax Junior with alcohol

Drinking alcohol during treatment may cause severe diarrhea, vomiting, abdominal pain.

Using Zyfurax Junior with food and drink

The medicine should be used at the same time, maintaining a strict diet that excludes juices, raw vegetables and fruits, spicy and hard-to-digest foods.

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 using this medicine.
Zyfurax Junior is not recommended during pregnancy and breastfeeding.

Driving and using machines

Zyfurax Junior has no influence or negligible influence on the ability to drive and use machines.

Zyfurax Junior contains tartrazine and sunset yellow FCF.

The medicine may cause allergic reactions.

3. How to use Zyfurax Junior

This medicine should always be used exactly as described in the patient leaflet or as advised by
the doctor, pharmacist, or nurse. In case of doubt, the patient should consult their doctor, pharmacist, or nurse.
The medicine is for oral use.

Recommended dose:

Adults:

8 tablets per day (800 mg) in 2-4 divided doses
Children over 6 years old:
6 to 8 tablets per day (600 to 800 mg) in 2-4 divided doses
Without consulting a doctor, the medicine should not be used for more than 3 days.

Use in children

Zyfurax Junior should not be used in children under 6 years old.

Using a higher dose of Zyfurax Junior than recommended

In case of taking a higher dose of the medicine than recommended, the patient should induce vomiting and consult their doctor or pharmacist.

Missing a dose of Zyfurax Junior

In case of missing a dose, the patient should take it as soon as possible.
A double dose should not be taken to make up for the missed dose.

Stopping the use of Zyfurax Junior

In case of any further doubts about the use of the medicine, the patient should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Zyfurax Junior can cause side effects, although not everybody gets them.
Zyfurax Junior is usually well-tolerated.
Allergic reactions may occur, such as:
rash,
urticaria,
angioedema (swelling of soft tissues of the face, lips, tongue, sometimes with accompanying laryngeal edema that may make breathing difficult) or anaphylactic shock
(a life-threatening allergic reaction with symptoms such as itching, urticaria, shortness of breath,
drop in blood pressure, rapid heartbeat).

Reporting side effects

If any side effects occur, including any possible side effects not listed in the leaflet, the patient should inform 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 181 C, 02-222 Warsaw,
tel. +48 22 49 21 301, fax: + 48 22 49 21 309,
e-mail: ndl@urpl.gov.pl .
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Zyfurax Junior

Store in a temperature below 25°C. Store in the original packaging.
The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the stated 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 Zyfurax Junior contains

• The active substance of the medicine is nifuroxazide. One tablet contains 100 mg of nifuroxazide.
• The other ingredients (excipients) are: potato starch, povidone K-30, magnesium stearate; coating Opadry II 85F22064 Yellow with the composition: polyvinyl alcohol, macrogol 3350, tartrazine, lake (E 104), talc, titanium dioxide (E 171), sunset yellow FCF, lake (E 110), indigo carmine, lake (E 132).

What Zyfurax Junior looks like and what the package contains

Zyfurax Junior is a yellow, round, biconvex tablet.
One package of the medicine contains 24 coated tablets (1 blister) in a cardboard box.

Marketing authorization holder and manufacturer

“PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK” S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Information about the medicine
tel. + 48 (22) 742 00 22
e-mail: informacjaoleku@hasco-lek.pl

Date of the last update of the leaflet: