Bioselac (Capsules) Instructions for Use

Marketing Authorization Holder

Rotapharm, Limited (United Kingdom)

Manufactured By

IBSS Biomed, S.A. (Poland)

ATC Code

G01AX14 (Lactobacilli)

Active Substance

Lactobacillus acidophilus (Grouping name)

Dosage Form

Bioselac

Vaginal capsules 108 CFU: 10 pcs.

Dosage Form, Packaging, and Composition

Vaginal capsules hard gelatin, white in color, containing a homogeneous cream-colored powder.

Excipients: skimmed milk powder – 13.8 mg, sucrose – 11.7 mg, sodium L-glutamate – 1.5 mg, potato starch – 37.5 mg, magnesium stearate – 2.25 mg, mannitol – 158.25 mg.

Composition of the hard gelatin capsule titanium dioxide – 1.52 mg, gelatin – 74.48 mg.

10 pcs. – blisters (1) – cardboard packs.
10 pcs. – bottles (1) – cardboard packs.

Clinical-Pharmacological Group

Drug regulating the balance of vaginal microflora

Pharmacotherapeutic Group

Eubiotic

Pharmacological Action

Lactobacillus rhamnosus is the most studied and well-known strain of probiotic bacteria. There are various subspecies of Lactobacillus rhamnosus.

Probiotics help restore the normal microflora of the intestine and vagina (after infectious diseases, antibiotic therapy), normalize the digestive activity of the gastrointestinal tract, improve metabolic processes, and contribute to the restoration of natural immunity.

Lactobacilli, which are normally found in the small and large intestines and in the vagina, maintain the acid-base balance necessary for normal digestion and bowel function (peristalsis), and the normal balance of vaginal microflora. They produce nutrients and create an optimal environment necessary for intestinal cells. Furthermore, they help digest food components, such as lactose. They are essential for the establishment and functioning of the immune system and prevent the excessive growth of harmful bacteria.

The therapeutic effect of this agent is manifested in a rapid decrease in vaginal pH to 4.0-4.7, active suppression of the growth and reproduction of pathogenic bacteria, restoration of the natural vaginal microflora and the physiological balance of microflora in the vagina.

When taken orally, lactobacilli help in restoring and maintaining the physiological balance of the intestinal microflora. They are resistant to the effects of digestive juices, thereby retaining activity when passing through the stomach and duodenum. Upon entering the intestine, lactobacilli can attach to the surface of the mucous membrane and act for a certain period of time.

Indications

For oral administration: prevention and complex treatment of antibiotic-associated diarrhea in adults.

For intravaginal use: bacterial vaginosis (during antibacterial therapy or immediately after its completion); preparation for planned gynecological surgeries; prenatal preparation of pregnant women at risk for bacterial vaginosis.

ICD codes

Dosage Regimen

Administer orally or intravaginally as directed by a physician.

For oral administration in adults for prevention of antibiotic-associated diarrhea: take one capsule daily during the entire course of antibiotic therapy.

For intravaginal administration in adults for bacterial vaginosis: insert one capsule deeply into the vagina once daily, preferably at bedtime, for 7 to 10 days.

For intravaginal administration as preparation for gynecological surgery: use one capsule daily for 7 days preceding the scheduled procedure.

For intravaginal administration for prenatal preparation of pregnant women: follow the specific regimen prescribed by the attending obstetrician-gynecologist.

Take oral capsules with a small amount of water. For concomitant antibiotic therapy, take this agent no earlier than 3 hours after the antibiotic dose.

This agent is contraindicated in children and adolescents under 18 years of age. Use only the dosage form and strength specified for the indication.

Adverse Reactions

Possible allergic reactions.

Contraindications

Hypersensitivity to this agent, candidiasis, childhood and adolescence under 18 years of age.

For oral administration: diabetes mellitus; immunodeficiency, including that caused by radiation and chemotherapy; history of gastrointestinal surgery; inflammatory bowel disease, celiac disease or pancreatitis; increased intestinal permeability syndrome; irritable bowel syndrome.

Use in Pregnancy and Lactation

Can be used if indicated.

Pediatric Use

Contraindicated for use in children and adolescents under 18 years of age.

Geriatric Use

The drug is approved for use in elderly patients.

Special Precautions

Before oral administration, the patient should consult with the attending physician in the following cases: body temperature above 38°C (100.4°F); traces of blood or mucus in the stool; diarrhea lasting more than 2 days; severe diarrhea with dehydration and weight loss; diarrhea combined with severe abdominal pain; diarrhea against the background of other severe concomitant conditions (severe illness, presence of structural heart disease, established central venous catheter); weakened immunity (e.g., in HIV infection or immunosuppressive therapy); use of corticosteroids; impaired intestinal barrier (including in the postoperative period); increased intestinal permeability syndrome.

When treating diarrhea, it is absolutely necessary to replenish lost fluids and electrolytes.

Drug Interactions

When used concomitantly with antibiotics, it is recommended to take this agent no earlier than 3 hours after taking the antibiotic.

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.