Inlax®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT INLAX® (INLAX)

Composition:

Active substance: Saccharomyces boulardii;

One hard capsule contains Saccharomyces boulardii 250 mg (not less than 5 × 10^9 viable cells);

Excipients: microcrystalline cellulose, maize starch, magnesium stearate;

Capsule shell composition: hypromellose, purified water, carrageenan (E 407), potassium acetate, copper complexes of chlorophylls and chlorophyllins (E 141).

Pharmaceutical form. Hard capsules.

Main physicochemical properties: transparent hard capsules of dark green color, containing powder ranging from almost white to beige.

Pharmacotherapeutic group. Antidiarrheal microbial agents. Saccharomyces boulardii.

ATC code A07FA02.

Pharmacological properties.

Pharmacodynamics.

INLAX® normalizes intestinal microflora and exerts a pronounced etiopathogenetic antidiarrheal effect. During passage through the gastrointestinal tract, Saccharomyces boulardii provides a biological protective effect on the normal intestinal microflora.

Main mechanisms of action of Saccharomyces boulardii:

• direct antagonism (antimicrobial activity) due to the ability of Saccharomyces boulardii to inhibit the growth of pathogenic and opportunistic microorganisms and fungi that disrupt intestinal biocenosis, such as: Clostridium difficile, Clostridium pneumoniae, Staphylococcus aureus, Pseudomonas aeruginosa, Candida krusei, Candida pseudotropicalis, Candida albicans, Salmonella typhi, Salmonella enteritidis, Escherichia coli, Shigella dysenteriae, Shigella flexneri, Klebsiella, Proteus, Vibrio cholerae, as well as Entamoeba histolytica, Giardia lamblia; Enterovirus, Rotavirus;
• antitoxic effect resulting from the production of proteases that degrade toxins and act on the enterocyte receptor to which the toxin binds (particularly with respect to toxin A of Clostridium difficile);
• antisecretory effect due to reduction in intracellular cyclic adenosine monophosphate (cAMP) levels in enterocytes, leading to decreased secretion of water and sodium into the intestinal lumen;
• enhancement of nonspecific immune defense by increasing the production of IgA and secretory components of other immunoglobulins;
• enzymatic activity due to increased activity of small intestinal disaccharidases (lactase, sucrase, maltase);
• trophic effect on the mucosa of the small intestine through the release of spermine and spermidine.

Genetically determined resistance of Saccharomyces boulardii to antibiotics justifies their concurrent use with antibiotics to protect the normal biocenosis of the gastrointestinal tract.

Pharmacokinetics.

After administration, a high concentration of Saccharomyces boulardii is rapidly achieved in the colon and maintained for 24 hours. Saccharomyces boulardii do not penetrate into the systemic circulation or mesenteric lymph nodes. After completion of treatment, Saccharomyces boulardii are completely eliminated in feces within 3–5 days.

Clinical characteristics.

Indications.

Prevention and treatment of colitis and diarrhea associated with antibiotic use.

Intestinal dysbiosis.

Acute and chronic bacterial diarrhea.

Acute viral diarrhea.

Irritable bowel syndrome.

Traveler’s diarrhea.

Pseudomembranous colitis and conditions caused by Clostridium difficile.

Diarrhea associated with long-term enteral nutrition.

Contraindications.

Hypersensitivity to any component of the medicinal product.

Contraindicated in patients with established central or peripheral venous catheters; critically ill patients or patients with impaired immunity – due to the risk of fungemia (see section "Special precautions"); patients receiving treatment in intensive care units; immunocompromised patients, such as: HIV-infected individuals, oncology patients, organ transplant recipients, and patients undergoing chemotherapy or radiation therapy, or those receiving prolonged high-dose corticosteroids.

Interaction with other medicinal products and other forms of interaction.

Do not take simultaneously with antifungal agents when administered orally or systemically.

Special precautions for use.

If symptoms of the disease persist for more than 2 days of treatment at the usual dosage, a physician should be consulted and dosage adjustment considered.

INLAX® contains a live culture. Therefore, the product should not be mixed with very hot (above 50°C) or cold beverages, alcoholic liquids, or very hot or cold food.

Treatment does not replace rehydration when rehydration is necessary. The volume and route of fluid administration (oral/intravenous) should be based on the severity of diarrhea, patient's age, and general condition.

Due to the risk of environmental contamination, capsules should not be opened in patient rooms.

Very rare cases of fungemia (and positive blood cultures for Saccharomyces strains), as well as sepsis, have been reported, primarily in patients with central venous catheters, critically ill patients, or immunocompromised patients. Most reported cases presented with fever. In most instances, outcomes were favorable after discontinuation of Saccharomyces boulardii, antifungal therapy, and, if necessary, catheter removal. However, fatal outcomes have occurred in some critically ill patients (see sections "Contraindications" and "Side effects").

As with all medicinal products containing live microorganisms, special care should be taken when handling Saccharomyces boulardii in the presence of patients, particularly those with central venous catheters, but also those with peripheral catheters, even if they are not receiving Saccharomyces boulardii treatment, to prevent any contamination via hands and/or airborne dissemination of microorganisms.

If microbiological stool examinations are performed in patients during or shortly after treatment with a medicinal product containing S. boulardii, laboratory personnel should be informed that the patient is receiving this treatment, as false-positive results may occur.

When preparing probiotics for administration, healthcare personnel must use disposable medical gloves. Gloves must be destroyed after use. Healthcare personnel should perform hygienic hand disinfection.

Use during pregnancy or breastfeeding.

To date, no clinically significant malformative or fetotoxic effects have been observed.

Monitoring of pregnancy in women taking this medicinal product is insufficient to exclude any risk. Therefore, as a precautionary measure, it is advisable to avoid using the product during pregnancy.

During breastfeeding, the product may be used under medical supervision.

Ability to affect reaction speed when driving or operating machinery. No effect.

Dosage and Administration

For adults and children aged 6 years and older: take 1–2 capsules 1–2 times daily. Maximum daily dose: 4 capsules.

Recommended treatment duration:

• Acute diarrhea: 3–5 days;
• Treatment of dysbiosis, chronic diarrhea syndrome, irritable bowel syndrome:
  10–14 days;
• Prevention and treatment of antibiotic-associated diarrhea and pseudomembranous colitis:
  INLAX® should be administered concomitantly with antibiotics, starting on the first day of antibiotic therapy and continuing until the end of antibiotic treatment;
• Traveler’s diarrhea: begin administration 5 days before departure, 1 capsule daily, continuing throughout the entire trip; discontinue on the day of return from the destination country. The medicinal product should be taken every morning on an empty stomach. Maximum duration of use: 30 days.

Capsules should be taken with water.

Due to the risk of airborne transmission, capsules must not be opened in patient wards. Healthcare professionals should wear disposable gloves when preparing probiotics for administration, remove them promptly afterwards, and thoroughly wash their hands (see section "Special Instructions").

Children.
For use in children aged 6 years and older. For children under 6 years of age, administration of Saccharomyces boulardii in the form of lyophilized powder for oral use is recommended.

Overdose

Slight overdose does not cause adverse reactions. In case of significant overdose, symptoms such as flatulence, nausea, vomiting, or worsening of adverse reactions may occur.

Treatment: gastric lavage, administration of activated charcoal and/or symptomatic therapy.

Adverse Reactions

Gastrointestinal disorders: transient epigastric discomfort not requiring discontinuation of the medicinal product, bloating, constipation – frequency not known.

In individuals with individual hypersensitivity to any component of the medicinal product, hypersensitivity reactions may occur, including skin rashes, pruritus, exanthema, urticaria, anaphylactic reactions, angioneurotic edema, anaphylactic shock, Quincke's edema, dyspnea.

Very rarely, fungemia is possible.

Sepsis may occur in hospitalized patients with central or peripheral venous catheters, critically ill patients, or patients with impaired immunity – frequency not known (see section "Special precautions for use").

If allergic reactions occur, administration of the medicinal product should be discontinued.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after medicinal product authorization is of great importance. It allows ongoing monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals and patients, or their legal representatives, are encouraged to report any suspected adverse reactions and lack of efficacy of the medicinal product via the Automated Information System for Pharmacovigilance at the following link: https://aisf.dec.gov.ua.

Shelf life: 2 years.

Storage conditions: Store at a temperature not exceeding 25 °C, in the original packaging, in a place protected from light and moisture. Keep out of reach of children.

Packaging: 10 hard capsules in a blister; 1 blister in a sachet; 1 sachet in a carton.

Supply category: Over-the-counter (without prescription).

Manufacturer: ABELA PHARM DOO BEOGRAD (manufacturing, primary and secondary packaging, batch release) / ABELA PHARM DOO BEOGRAD.

Manufacturer's address: Brace Trninic 31, 22305 Stari Banovci, Republic of Serbia.

Marketing Authorization Holder: JSC "Farmak".

Address of the Marketing Authorization Holder: 63 Kyrylivska St., Kyiv, 04080, Ukraine.