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Florin® Forte (Capsules, Powder) Instructions for Use

ATC Code

A07FA (Antidiarrheal microorganisms)

Active Substances

Bifidobacterium bifidum (Group Group name)

Lactobacillus plantarum (Group Group name)

Clinical-Pharmacological Group

Drug regulating the balance of intestinal microflora (probiotic)

Pharmacotherapeutic Group

MIBP-eubiotic

Pharmacological Action

Bifidobacteria preserve and improve the physiological balance of the intestinal microflora and restore the deficiency of bifidobacteria; exhibit antagonistic activity against a wide range of pathogenic and opportunistic microorganisms; neutralize toxic metabolic products; promote the absorption of minerals (including iron), proteins, carbohydrates; possess vitamin-forming activity, particularly of B vitamins; prevent the formation of protracted forms of intestinal infections; increase the body’s nonspecific resistance.

Lactobacilli are an important component of the normal microflora of the digestive and genital tracts of mammals. They possess diverse biological properties and actively participate in metabolic and regulatory processes. They exhibit pronounced antagonistic activity against a wide range of aerobic and facultative anaerobic gram-negative and gram-positive bacteria, as well as some obligate anaerobic microorganisms. This activity is most pronounced in representatives of the species Lactobacillus acidophilus, L. plantarum, L. casei, L. fermentii, L. buchneri.

Bifidobacteria and lactobacilli, interacting synergistically, maintain and regulate the physiological balance of the intestinal microflora, increasing the resistance of the intestinal mucosa to pathogenic microorganisms; inhibit the translocation of pathogenic bacteria in the colon, possess antagonistic activity against many pathogenic and opportunistic microorganisms, and normalize immunity indicators when it is suppressed.

Indications

Diseases accompanied by a disturbance of the normal intestinal microflora with a deficiency of bifidobacteria, lactobacilli, or normal Escherichia coli; acute intestinal infections caused by rotaviruses and/or opportunistic microflora; acute intestinal infections of unknown etiology; acute respiratory diseases of both viral and microbial origin; chronic gastrointestinal diseases, including those with identified hemolytic Escherichia coli and associations of opportunistic microorganisms in high titers; restoration of normal intestinal flora during the convalescence period after illnesses; dysbacteriosis of various etiologies.

ICD codes

ICD-10 code Indication
A04 Other bacterial intestinal infections
A05 Other bacterial food poisonings, not elsewhere classified
A08.0 Rotaviral enteritis
A09.0 Other and unspecified gastroenteritis and colitis of infectious origin (infectious diarrhea NOS)
J06.9 Acute upper respiratory infection, unspecified
K52.9 Noninfective gastroenteritis and colitis, unspecified
K63.8 Other specified diseases of intestine
Z54 Convalescence
ICD-11 code Indication
1A01 Intestinal infection caused by other Vibrio species
1A03.Z Intestinal infections caused by Escherichia coli, unspecified
1A0Z Bacterial intestinal infections, unspecified
1A1Z Bacterial foodborne intoxications, unspecified
1A22 Gastroenteritis due to Rotavirus
1A40.Z Infectious gastroenteritis or colitis, unspecified
CA07.0 Acute upper respiratory tract infection of unspecified site
DA90.0 Syndromic diarrhea
DA92.1 Pneumatosis intestinalis of the small intestine
DA98.Z Polyps of small intestine, unspecified
DB31.1 Pneumatosis of the colon
DB36.Z Certain infections of the colon, unspecified
DE2Z Diseases of the digestive system, unspecified
QB7Z Convalescence, unspecified

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Administer orally.

Determine the dose and duration individually based on the patient’s age, clinical condition, and the specific formulation prescribed.

For the capsule formulation, swallow whole with a sufficient amount of liquid.

For the powder formulation, mix the contents of the sachet with a small volume of cool or lukewarm water (not exceeding 40°C) immediately before use and ingest the resulting suspension.

For acute intestinal infections and acute respiratory diseases, initiate therapy at the first signs of illness.

For chronic gastrointestinal diseases and dysbiosis, follow the course prescribed by the physician.

To restore normal intestinal flora during convalescence, continue use as directed after the acute phase of illness has resolved.

Do not dissolve the powder in hot liquids.

Do not store the reconstituted suspension.

Avoid concomitant administration with antibiotics; if unavoidable, administer the probiotic at the maximum possible time interval from the antibiotic dose.

Adverse Reactions

Possible: allergic reactions, nausea.

Contraindications

Hypersensitivity to the components of the drug used.

Use in Pregnancy and Lactation

The possibility of use during pregnancy and lactation (breastfeeding) depends on the dosage form used.

Special Precautions

Concomitant use with antibiotics is not recommended, nor is dissolving the drug in hot water (above 40°C) or storing it in dissolved form.

Drug Interactions

The action of drugs containing Bifidobacterium bifidum is enhanced by vitamins (especially B vitamins) and reduced by antibiotics.

Storage Conditions

Store at 2°C (36°F) to 8°C (46°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

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.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Avan-Bio, LLC (Russia)

Manufactured By

Probiofarm, LLC (Russia)

Dosage Form

Bottle OTC Icon Florin® Forte Powder for oral administration 50 million CFU+50 million CFU: sachets 10, 20, or 30 pcs.

Dosage Form, Packaging, and Composition

Powder for oral administration light gray or dark gray in color with black specks, with a faint fermented milk odor.

1 sachet
Bifidobacterium bifidum (sorbed on activated charcoal) Not less than 50 million CFU
Lactobacillus plantarum Not less than 50 million CFU

Excipients : lactose monohydrate – up to 0.85 g.

Sachets made of multilayer metal-polymer material (10) – cardboard packs.
Sachets made of multilayer metal-polymer material (20) – cardboard packs.
Sachets made of multilayer metal-polymer material (30) – cardboard packs.

Marketing Authorization Holder

Avan-Bio, LLC (Russia)

Manufactured By

Probiofarm, LLC (Russia)

Dosage Form

Bottle OTC Icon Florin® forte Capsules 50 million CFU+50 million CFU: 10, 15, 20 or 30 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin, white body, yellow cap; capsule contents – powder light gray or dark gray in color with black specks, with a faint fermented milk odor.

1 sachet
Bifidobacteria B. bifidum No. 1, sorbed on activated carbon Not less than 50 million CFU*
Lactobacilli L. plantarum 8P-A3 Not less than 50 million CFU*

* CFU – colony-forming unit.

Excipients : components of the drying medium (sucrose-gelatin): sucrose – 8.08-8.24 mg, gelatin – 1.07-1.09 mg, activated charcoal – 2.73-2.79 mg, magnesium stearate – 1-10 mg, lactose monohydrate – up to 0.2 g.

Capsule shell composition capsule body – titanium dioxide (white color) 1.0-2.0%, gelatin up to 100%; capsule cap – titanium dioxide 1.0-2.0%, iron oxide (yellow color) 0.05-1.8%, gelatin up to 100%.

10 pcs. – polymer jars (1) – cardboard packs.
15 pcs. – polymer jars (1) – cardboard packs.
20 pcs. – polymer jars (1) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.

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