Bifiform^® (Capsules) Instructions for Use

Marketing Authorization Holder

Cheleon Rus, JSC (Russia)

Manufactured By

Haleon Italy Manufacturing, S.r.l. (Italy)

Contact Information

CHELEON RUS JSC (Russia)

ATC Code

A07FA (Antidiarrheal microorganisms)

Dosage Form

Bifiform®

Enteric-coated capsules: 15, 20, 30, 40, 60 or 100 pcs.

Dosage Form, Packaging, and Composition

Enteric-coated capsules hard gelatin, size 3, white or almost white; capsule contents – powder from white to light yellow.

Excipients: anhydrous dextrose, yeast starter*, locust bean gum, lactulose, magnesium stearate.

* represents Saccharomyces cerevisiae yeast.

Capsule shell composition gelatin, titanium dioxide, magnesium stearate, methacrylic acid and methyl methacrylate copolymer [1:1], methacrylic acid and ethyl acrylate copolymer [1:1] [30% dispersion], talc, macrogol 6000, purified soybean oil, diacetylated glycerides.

15 pcs. – aluminum tubes (1) – cardboard packs.
20 pcs. – aluminum tubes (1) – cardboard packs.
30 pcs. – aluminum tubes (1) – cardboard packs.
40 pcs. – aluminum tubes (1) – cardboard packs.
60 pcs. – aluminum tubes (1) – cardboard packs.
100 pcs. – aluminum tubes (1) – cardboard packs.

The secondary packaging may have a first-opening control.

Clinical-Pharmacological Group

Drug regulating the balance of intestinal microflora

Pharmacotherapeutic Group

Antidiarrheal, intestinal anti-inflammatory/antimicrobial agents; antidiarrheal microorganisms

Pharmacological Action

The strains of Enterococcus faecium and Bifidobacterium longum included in the drug are natural symbiotic bacteria inhabiting the gastrointestinal tract.

The drug has a normalizing effect on the quantitative and qualitative composition of the intestinal microflora.

The action is due to both the direct effect of the components included in the drug (high antagonistic activity against pathogenic and opportunistic microorganisms) and an indirect effect – stimulation of the local intestinal immune link (activation of immunoglobulin A synthesis, induction of endogenous interferon synthesis).

Bifidobacterium longum has high survival in the human intestine and a high growth rate.

The inclusion of the non-pathogenic enterococcus Enterococcus faecium, which normally colonizes the small intestine, allows for a positive effect on the condition and digestive functions of not only the large intestine but also the small intestine, especially in the presence of fermentative dyspepsia and symptoms of flatulence.

Pharmacokinetics

No information available.

Indications

Prevention in adults and children from 2 years

• Prevention of dysbiosis;
• Support of the immune system (immunity);
• Prevention of antibiotic-associated diarrhea.

Treatment in adults and children from 2 years

• Diarrhea caused by acute and exacerbation of chronic gastroenteritis;
• Diarrhea caused by rotavirus infection;
• Antibiotic-associated diarrhea;
• Traveler’s diarrhea (acute diarrhea developing when traveling to other climatic zones);
• As part of complex therapy for acute intestinal infections;
• As part of complex therapy for chronic gastrointestinal diseases such as colitis, irritable bowel syndrome and other functional gastrointestinal disorders;
• Normalization of intestinal microflora, treatment of dysbiosis;
• Lactose intolerance;
• As part of complex standard eradication therapy in patients with Helicobacter pylori infection.

ICD codes

Dosage Regimen

* The duration of administration may be adjusted. If necessary, the course of treatment can be repeated.

Children from 2 years – 1 capsule 2-3 times/day.

Bifiform^® should not be used in children under 2 years of age.

When prescribed to children and patients who cannot swallow a whole capsule, it should be carefully broken, the contents gently poured into a spoon without loss and mixed with a small amount of liquid.

Adverse Reactions

When used in recommended doses for the established indications, adverse reactions have not been identified.

Contraindications

• Individual hypersensitivity to the components of the drug.

Use in Pregnancy and Lactation

The use of the drug during pregnancy and breastfeeding is considered safe, since the drug is not absorbed and does not have a systemic effect.

Pediatric Use

Prescribed for children from 2 years.

Special Precautions

The maximum daily dose should not be exceeded.

In case of intolerance to certain sugars, the patient should consult the attending physician before taking this medicinal product.

Effect on ability to drive vehicles and machinery

The drug does not affect the ability to drive vehicles and work with machinery.

Overdose

Symptoms of overdose have not been previously reported.

Treatment in case of significant exceeding of the recommended doses, medical supervision is advisable.

Drug Interactions

The drug can be used in combination with other medicinal products.

Simultaneous administration with antibiotics is allowed, including from the first day of antibacterial therapy for the prevention of dysbiosis and antibiotic-associated diarrhea.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 2 years. Do not use after the expiration date printed on the packaging.

Transport at a temperature not exceeding 25°C (77°F).

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.