Flonivin BS (Capsules) Instructions for Use

Marketing Authorization Holder

Galenika Crna Gora D.O.O. (Montenegro)

ATC Code

A07FA01 (Lactic acid-producing microorganisms)

Dosage Form

Flonivin BS

Capsules 35 mg: 16 pcs.

Dosage Form, Packaging, and Composition

Capsules are hard gelatin, size No. 2, matte, milky-white in color; the capsule contents are an amorphous powder of white-gray or pale-yellow color, with a specific odor.

Excipients: calcium carbonate – 35 mg, kaolin – 100 mg.

Capsule shell composition: gelatin – 61.74 mg, titanium dioxide (CI77891) – 1.26 mg.

8 pcs. – blisters (2) – cardboard packs.

Clinical-Pharmacological Group

Antidiarrheal drug regulating intestinal microflora balance

Pharmacotherapeutic Group

MIBP-eubiotic

Pharmacological Action

The bacteria Bacillus cereus IP 5832 secrete broad-spectrum antibacterial substances that suppress the development of pathogenic and opportunistic bacteria, exerting antimicrobial and antidiarrheal effects, and restore the intestinal microflora.

The bacterial spores contained in the drug are resistant to the action of gastric juice. Their germination into vegetative forms of bacteria occurs in the intestine.

Indications

• Treatment of acute and chronic diarrhea of various origins;
• Treatment of colitis, enterocolitis;
• Prevention and treatment of intestinal dysbiosis (including those developed as a result of antibiotic, chemotherapy, or radiotherapy);
• Fermentation disorders (flatulence).

ICD codes

Dosage Regimen

Administer orally.

Take the capsules one hour before meals.

For adults, the dose is two capsules taken two to four times daily.

For children over 7 years of age, the dose is one to two capsules taken two to three times daily.

The standard treatment duration for both groups is seven to ten days.

Swallow the capsules whole with a sufficient amount of liquid.

Do not take the drug with hot liquids or alcoholic beverages.

If no improvement is observed within three days of starting treatment, discontinue use and consult a physician.

For the prevention of dysbiosis during antibiotic therapy, initiate treatment concurrently with the antibiotic.

Continue administration for several days after the course of antibiotics is completed.

The drug is compatible with most antibiotics and sulfonamides.

Inform your physician about all concurrently taken medications.

Adverse Reactions

When the drug is used according to the indications in the recommended doses, no adverse effects have been identified.

Contraindications

• Primary immunodeficiencies;
• Hypersensitivity to any of the components of the drug.

Pediatric Use

Flonivin BS is prescribed for children over 7 years of age – 1-2 capsules 2-3 times/day for 7-10 days.

Special Precautions

The drug is used as prescribed by a doctor; the drug should not be taken uncontrollably or on the advice of third parties.

If improvement does not occur within 3 days of treatment, the drug should be discontinued.

Drug Interactions

The drug is resistant to the action of various antibiotics and sulfonamide drugs, so it can be prescribed together with the latter. It is necessary to inform the attending physician about simultaneously taken medications.

Storage Conditions

Store the drug in a dry place, protected from light, at a temperature not exceeding 25°C (77°F). Keep out of reach of children.

Shelf Life

Shelf life – 3 years. Do not use the drug after the expiration date printed on the packaging.

Dispensing Status

The drug is approved for use as an over-the-counter product.

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.