Ersefuryl^® (Capsules) Instructions for Use

Marketing Authorization Holder

Sanofi-Aventis France (France)

Manufactured By

Delpharm Dijon (France)

ATC Code

A07AX03 (Nifuroxazide)

Active Substance

Nifuroxazide (Rec.INN registered by WHO)

Dosage Form

Ersefuryl®

Capsules 200 mg: 14 or 28 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin, size No. 1; yellow body, yellow cap; capsule contents – yellow powder.

Excipients: corn starch, sucrose, magnesium stearate.

Capsule composition body: gelatin, titanium dioxide (E171), iron oxide yellow dye (E172); cap: gelatin, titanium dioxide (E171), iron oxide yellow dye (E172).

14 pcs. – blisters (1) – cardboard packs.
14 pcs. – blisters (2) – cardboard packs.

Clinical-Pharmacological Group

Intestinal antiseptic. Antidiarrheal agent

Pharmacotherapeutic Group

Antimicrobial agent – nitrofuran

Pharmacological Action

Nifuroxazide is an antimicrobial agent, a nitrofuran derivative.

It blocks the activity of dehydrogenases and inhibits the respiratory chains, the tricarboxylic acid cycle, and a number of other biochemical processes in the microbial cell.

It destroys the microbial cell membrane and reduces toxin production by microorganisms.

It is highly active against Campylobacter jejuni, Escherichia coli, Salmonella spp., Shigella spp., Clostridium perfringens, Vibrio cholerae, pathogenic Vibrions and Vibrio parahaemolytique, Staphylococcus spp.

Weakly sensitive to nifuroxazide: Citrobacter spp., Enterobacter cloacae and Proteus indologenes.

Resistant to nifuroxazide: Klebsiella spp., Proteus mirabilis, Providencia spp., Pseudomonas spp.

It does not disturb the balance of the intestinal microflora.

In acute bacterial diarrhea, it restores intestinal eubiosis.

When infected with enterotropic viruses, it prevents the development of bacterial superinfection.

Pharmacokinetics

After oral administration, Nifuroxazide is practically not absorbed from the digestive tract and exerts its antibacterial action exclusively in the intestinal lumen.

Nifuroxazide is eliminated by the intestine: 20% unchanged, and the remaining amount of nifuroxazide – chemically altered.

Indications

• Acute bacterial diarrhea occurring without deterioration of general condition, fever, or intoxication.

ICD codes

Dosage Regimen

The drug is taken orally.

Adults are prescribed 200 mg (1 caps.) 4 times/day (6-hour interval between doses); children aged 6 to 18 years – 200 mg (1 caps.) 3-4 times/day (6-8 hour interval between doses); children aged 3 to 6 years are prescribed 200 mg (1 caps.) 3 times/day (8-hour interval between doses).

The duration of the treatment course is 5-7 days, but not more than 7 days.

If no improvement occurs within the first 3 days of administration, the patient should consult a doctor.

The drug should be used only according to the method of administration and in the doses indicated in the instructions. If necessary, the patient should consult a doctor before using the drug.

Adverse Reactions

Allergic reactions possible – skin rash, urticaria, angioedema, anaphylactic shock.

If any of the side effects listed in the instructions worsen, or any other side effects not listed in the instructions are noted, the patient must inform the doctor.

Contraindications

• Hypersensitivity to nifuroxazide, nitrofuran derivatives, or other components of the drug;
• Children under 3 years of age;
• Pregnancy;
• Fructose intolerance, glucose-galactose malabsorption syndrome, or sucrase and isomaltase deficiency (due to the presence of sucrose in the drug composition).

Use in Pregnancy and Lactation

Animal studies with nifuroxazide did not reveal a teratogenic effect. However, as a precaution, taking Nifuroxazide during pregnancy is not recommended (insufficient clinical experience of use during pregnancy).

During the lactation period, breastfeeding can be continued in case of a short course of treatment with the drug.

Pediatric Use

Contraindicated in children under 3 years of age.

Special Precautions

When treating diarrhea, rehydration therapy should be carried out simultaneously with nifuroxazide therapy.

In case of bacterial diarrhea with signs of systemic involvement (deterioration of general condition, fever, symptoms of intoxication or infection), the patient should consult a doctor to decide on the use of systemic antibacterial drugs.

If symptoms of hypersensitivity (shortness of breath, skin rash, skin itching) appear, the drug should be discontinued.

Alcohol consumption is prohibited during nifuroxazide therapy.

Information for patients with diabetes: one single dose (1 caps.) of Ersefuryl^® contains 72 mg of sucrose, which corresponds to 0.00072 XE. The maximum daily dose (4 caps.) contains 288 mg of sucrose, which corresponds to 0.0288 XE.

Effect on ability to drive vehicles and mechanisms

The drug Ersefuryl^® does not affect the ability to drive vehicles and mechanisms.

Overdose

Symptoms of overdose are unknown.

Treatment symptomatic therapy.

Drug Interactions

Concomitant use with drugs that cause disulfiram-like reactions and drugs that depress the function of the central nervous system is not recommended.

If the patient is taking other medications (including over-the-counter ones), a doctor should be consulted before using Ersefuryl^®.

Storage Conditions

The drug should be stored out of the reach of children, in a dry place at a temperature not exceeding 30°C (86°F).

Shelf Life

Shelf life – 5 years. Do not use the drug after the expiration date printed on the package.

Dispensing Status

The drug is available without a prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.