Linex®

INSTRUCTIONS for medical use of the medicinal product LINEX®

Composition:

Active substances: 1 capsule contains no less than 1.2 × 10⁷ CFU antibiotic-resistant lactic acid bacteria: no less than 4.5 × 10⁶ CFU Lactobacillus acidophilus (sp. L. gasseri), no less than 3.0 × 10⁶ CFU Bifidobacterium infantis, no less than 4.5 × 10⁶ CFU Enterococcus faecium;

Excipients: lactose monohydrate, potato starch, dextrin, magnesium stearate;

Capsule shell: gelatin, titanium dioxide (E 171).

Pharmaceutical form. Hard capsules.

Main physicochemical properties: capsule: white cap – white body, no marking; capsule contents: white powder.

Pharmacotherapeutic group.

Antidiarrheal microbial agents. ATC code A07FA01.

Pharmacological properties.

Pharmacodynamics.

Linex® is a combination drug containing 3 different types of lyophilized viable lactic acid bacteria originating from various segments of the intestine, which are part of the normal intestinal flora and maintain and regulate the physiological balance of intestinal microflora. The preventive and therapeutic effects of these microorganisms are achieved through several mechanisms:

• Fermentation of lactose shifts pH toward an acidic environment. The acidic environment suppresses the growth of pathogenic and conditionally pathogenic bacteria and ensures optimal activity of digestive enzymes;
• Lactic acid bacteria synthesize vitamins B1, B2, B6, B12, and vitamin K;
• They participate in the metabolism of bile acids and bile pigments;
• They prevent adhesion of pathogenic microorganisms to the intestinal wall;
• They synthesize substances with antibacterial activity (bacteriocins);
• They stimulate humoral immunity and local intestinal immunity.

Disturbances in the balance of lactic acid bacteria may occur due to various reasons (viral and bacterial infections, international travel, use of broad-spectrum antibiotics and chemotherapeutic agents, irradiation of abdominal and pelvic organs).

In newborns, delayed development of normal intestinal microflora may occur. All these factors may lead to gastrointestinal disorders accompanied by meteorism, diarrhea, and constipation.

Administration of Linex® capsules promotes maintenance of normal intestinal microflora and restoration of disturbed microbial balance in the intestine.

Pharmacokinetics.

After oral administration, lactic acid bacteria exert local effects within the gastrointestinal tract.

Due to the absence of systemic absorption, pharmacokinetic studies data are not available.

According to preclinical data, including standard safety, toxicity, genotoxicity, carcinogenicity, and teratogenicity studies, the drug is safe for use.

Clinical characteristics.

Indications.

For the complex treatment of intestinal dysbiosis, and for the prevention and treatment of diarrhea caused by:

• viral or bacterial infections of the gastrointestinal tract (e.g., rotavirus infection, traveler's diarrhea);
• use of antimicrobial agents (antibiotics or other synthetic antimicrobial drugs).

Contraindications.

Hypersensitivity to the components of the drug.

Interaction with other medicinal products and other forms of interaction.

Linex® capsules can be used concomitantly with antibiotics and chemotherapeutic agents. To enhance the drug's effectiveness, it is recommended to take Linex® capsules 3 hours after taking antibiotics and chemotherapeutic agents.

No clinically significant interactions with other medicinal products have been identified.

Instructions for use

Before starting treatment with Linex®, consult a physician in the following cases:

• body temperature above 38 °C;
• presence of occult blood or mucus in the stool;
• diarrhea lasting more than 2 days;
• severe diarrhea accompanied by dehydration and weight loss;
• diarrhea associated with severe abdominal pain;
• presence of other chronic diseases (e.g., diabetes mellitus, cardiovascular diseases) or immunodeficiency (e.g., HIV infection).

Treatment of diarrhea in children under 6 years of age should be conducted only under medical supervision.

One capsule contains 98.28 mg of lactose; therefore, the product should not be administered to patients with rare hereditary galactose intolerance, lactase deficiency, or glucose-galactose malabsorption syndrome.

The product contains milk protein residues, which may provoke allergic reactions.

Use during pregnancy or breastfeeding.

There are no reports of adverse effects associated with the use of Linex® during pregnancy or breastfeeding. However, in cases of severe diarrhea, precautionary measures should be taken to avoid fluid and electrolyte depletion or other adverse effects that could pose a risk to the fetus or pregnant woman. Treatment of diarrhea during pregnancy or breastfeeding should be conducted only under medical supervision. The use of Linex® during these periods is not recommended due to insufficient data on its safety.

Ability to influence reaction speed when driving or operating machinery.

No data available.

Dosage and Administration.

Infants and children up to 2 years of age: 1 capsule three times a day.

Children aged 2 to 12 years: 1–2 capsules three times a day.

Adults and children aged 12 years and older: 2 capsules three times a day.

Treatment of diarrhea in children under 6 years of age should be carried out under medical supervision.

If a child cannot swallow the capsule whole, it should be opened and the contents mixed with a teaspoon of liquid (tea, juice, sweetened water). The resulting mixture must not be stored.

To prevent the adverse effect of gastric juice on lactic acid bacteria, the medication should be taken during meals. Linex® capsules should not be taken with alcohol or hot beverages.

The medication should be taken until the patient's condition improves.

The duration of treatment depends on the cause of the disease and individual characteristics of the organism.

If diarrhea does not stop within 2 days despite taking the medication, consult a doctor.

In case of diarrhea, special attention should be paid to replenishing lost fluids and electrolytes.

Children.

Can be used in pediatric practice.

Overdose.

No cases of overdose have been reported.

Side effects.

Side effects are very rare (≤ 1:10,000). Possible hypersensitivity reactions, rash, itching.

Shelf life.

2 years.

After first opening of the bottle – 4 months (for capsules in bottle).

Storage conditions.

Store at a temperature not exceeding 25 °C in the original packaging.

Keep bottle tightly closed (for capsules in bottle).

Keep out of reach of children.

Packaging.

32 capsules in a bottle; 1 bottle in a cardboard box.

8 capsules in a blister; 2 (8 × 2), 4 (8 × 4), or 6 (8 × 6) blisters per cardboard box.

Category of supply.

Over-the-counter.

Manufacturer.

Lek Pharmaceuticals d. d., Slovenia (responsible for batch release).

Manufacturer's address and location of operations.

Verovskova 57, 1526 Ljubljana, Slovenia.