Zifurax Babi

ZYFURAX BABY

220 mg/5 ml, oral suspension
Nifuroxazide
You should read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor.
• This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor. See section 4.

Table of contents of the leaflet

1. What is Zyfurax baby and what is it used for
2. Important information before using Zyfurax baby
3. How to use Zyfurax baby
4. Possible side effects
5. How to store Zyfurax baby
6. Contents of the pack and other information

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

The active substance of Zyfurax baby is nifuroxazide. It has antibacterial effects against most bacteria that cause intestinal infections. It acts on Gram-positive bacteria (Staphylococcus and Streptococcus) and Gram-negative microorganisms (Salmonella, Shigella, Escherichia). It does not act on bacteria of the Proteus, Pseudomonas, Providencia genus. It does not disrupt the normal microbiological balance of the gastrointestinal tract.

Indications for use

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

2. Important information before using Zyfurax baby

If the patient is allergic to nifuroxazide, 5-nitrofuran derivatives or any of the other ingredients of Zyfurax baby (see section 6).
Warnings and precautions
Caution should be exercised when using Zyfurax baby in newborns and infants under 3 months of age due to the risk of hemolytic anemia.
Zyfurax baby should be avoided in newborns and infants under 1 month of age.
In case of hypersensitivity reactions, the use of the medicine should be discontinued immediately and a doctor consulted.

Concomitant use of other medicines

The doctor should be informed about all medicines being taken, including those available without a prescription.
Nifuroxazide may enhance the effect of anticoagulant medicines of the coumarin type.

Pregnancy and breastfeeding

Zyfurax baby should be used during pregnancy and breastfeeding only if absolutely necessary and under close medical supervision.

Driving and using machines

Zyfurax baby does not affect the ability to drive and use machines.

3. How to use Zyfurax baby

This medicine should always be used as directed by the doctor. In case of doubts, the doctor or pharmacist should be consulted.
Dosage
The recommended dose of Zyfurax baby depends on the patient's body weight:

• Children from 6 months to 1 year of age: 5 ml (100 mg of nifuroxazide) 3 times a day.
• Children from 1 year to 6 years of age: 10 ml (200 mg of nifuroxazide) 3 times a day.
• Children over 6 years of age and adolescents: 20 ml (400 mg of nifuroxazide) 3 times a day.

The medicine should be taken orally, preferably 30 minutes before a meal.
Duration of treatment: the medicine should not be used for more than 7 days without consulting a doctor.
In case of improvement of symptoms, treatment should be continued for at least 3 days.
In case of worsening of symptoms or lack of improvement after 3 days of treatment, a doctor should be consulted.

4. Possible side effects

Like all medicines, Zyfurax baby can cause side effects, although not everybody gets them.
Common side effects (may affect up to 1 in 10 people):

• Nausea
• Vomiting
• Diarrhea
• Abdominal pain

Rare side effects (may affect up to 1 in 1000 people):

• Rash
• Itching
• Urticaria

Very rare side effects (may affect up to 1 in 10,000 people):

• Allergic reactions (e.g. angioedema, anaphylactic shock)
• Hepatitis
• Blood disorders (e.g. hemolytic anemia, leukopenia, thrombocytopenia)

Reporting side effects
If any side effects occur, they should be reported to the doctor or pharmacist, or directly to the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.

5. How to store Zyfurax baby

Store in a temperature below 25°C, in the original packaging, in a place inaccessible and invisible to children.
Do not use after the expiry date stated on the packaging.

6. Contents of the pack and other information

What Zyfurax baby contains:
The active substance is nifuroxazide. 200 mg of nifuroxazide in 5 ml of suspension.
Other ingredients are: propylene glycol, sucrose, xanthan gum, strawberry flavor, purified water.
What Zyfurax baby looks like and what the pack contains:
Oral suspension with a strawberry flavor. The medicine is in a plastic bottle with a child-resistant cap. The pack also includes a measuring syringe.
Packaging: 100 ml suspension.
Marketing authorization holder:
Polpharma S.A.
ul. Pelplińska 19
83-200 Starogard Gdański
Manufacturer:
Polpharma S.A.
ul. Pelplińska 19
83-200 Starogard Gdański
Date of last update of the leaflet: 01.02.2018

Zyfurax baby with food and drink

The medicine should be taken with a diet that excludes juices, raw vegetables and fruits, as well as spicy and hard-to-digest foods.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, thinks she may be pregnant or plans to have a child, she should consult a doctor or pharmacist before using this medicine.
Zyfurax baby should not be used in pregnant and breastfeeding women.

Driving and using machines

Zyfurax baby does not affect the ability to drive and use machines.

Zyfurax baby contains sorbitol

If the patient has previously been diagnosed with intolerance to some sugars, the patient should contact their doctor before taking the medicine.

Zyfurax baby contains sodium

This medicine contains less than 1 mmol (39 mg) of sodium per dose, which means it is considered "sodium-free".

Zyfurax baby contains methyl parahydroxybenzoate and propyl parahydroxybenzoate

The medicine may cause allergic reactions (possible late reactions).

3. How to use Zyfurax baby

This medicine should always be used as directed by the doctor. In case of doubts, the doctor should be consulted.
Recommended dose

• for children from 1 to 6 months of age: 110-220 mg (2.5-5 ml) 2 times a day, every 12 hours.
• for children from 7 months to 6 years of age: 220 mg (5 ml) 3 times a day, every 8 hours.
• for adults and children from 7 years of age: 220 mg (5 ml) 4 times a day, every 6 hours.

A measuring syringe (5 ml) is attached to the packaging.
Zyfurax baby should be taken orally.
Before each use, the bottle should be shaken to obtain a uniform suspension. After measuring the prescribed dose, the suspension can be mixed with water.
Taking a higher dose than recommended
In case of taking a higher dose than recommended, a doctor or the nearest hospital should be consulted immediately.
Missing a dose of the medicine
A double dose should not be taken to make up for a missed dose. The next dose should be taken as directed.
Stopping the use of the medicine
The use of Zyfurax baby should not be stopped before the time specified by the doctor, even if the patient's condition improves. Premature discontinuation of treatment may cause the disease to recur.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common side effects (may affect more than 1 in 10 people):

• diarrhea
• nausea
• vomiting

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4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
There may be hypersensitivity reactions, such as: rash, urticaria, angioedema (swelling of soft tissues of the face, lips, tongue, and possibly with accompanying laryngeal edema, which may make breathing difficult) or anaphylactic shock (a life-threatening allergic reaction), with symptoms such as: itching, urticaria, shortness of breath, decrease in blood pressure, rapid heartbeat).
Reporting side effects
If any side effects occur, including any side effects not listed in the leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (current address, phone number and fax www.urpl.gov.pl). By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Zyfurax baby

Store in a closed original packaging, at a temperature below 25°C.
The medicine should be stored in a place that is invisible and inaccessible to children.
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 pharmacist should be asked how to dispose of medicines that are no longer used. This will help protect the environment.

6. Contents of the pack and other information

Contents of the pack:

• Active substance: (excipient): 5 ml contains 220 mg of nifuroxazide.
• Other ingredients: propylene glycol, benzoic acid, strawberry flavor, (23%), sorbitol 70% solution (does not contain fructose), purified water.

Packaging: Dark glass bottle with a high-density polyethylene cap and a measuring device. 100 ml
Suspected adverse reaction to Zyfurax baby
In case of suspected adverse reactions or doubts, a doctor or pharmacist should be consulted.

Manufacturer

Polpharma S.A.
ul. Pelplińska 19
83-200 Starogard Gdański
Poland

Date of update of the leaflet

01.08.2011

Date of last update of the leaflet:

PPF HASCO-LEK S.A., Al. Jana Pawła II 100, 00-828 Warszawa
Department of Clinical Trials of Medicinal Products
HEAD
Pharmacist Małgorzata Han-Marek
Dworski