Linex forte®
Ukraine
Table of Contents
INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT LINEX forte®
Composition:
Active substances: 1 capsule contains a mixture of probiotics: Lactobacillus acidophilus – not less than 1 × 109 CFU (approximately 25.74 mg), Bifidobacterium animalis subsp. lactis – not less than 1 × 109 CFU (approximately 3.06 mg);
Excipients: maltodextrin, Beneo® Synergy 1 (inulin, oligofructose (glucose + fructose + sucrose)), magnesium stearate;
Capsule shell: hydroxypropylmethylcellulose, titanium dioxide (E 171), yellow iron oxide (E 172).
Pharmaceutical form. Hard capsules.
Main physicochemical properties: size 2 capsules, white body, yellow cap; capsule contents: powder from light beige to light pink with darker specks.
Pharmacotherapeutic group.
Antidiarrheal microbial agents. ATC code A07FA01.
Pharmacological Properties
Pharmacodynamics
Linex Forte® capsules contain Lactobacillus acidophilus (LA-5) and Bifidobacterium animalis subsp. lactis (BB-12). Both lactic acid bacteria are part of the normal human intestinal microflora.
Several mechanisms underlie their inherent prophylactic and therapeutic effects, preventing the growth of pathogenic bacteria:
- they contribute to lowering the pH in the intestinal tract (due to the ability of Lactobacillus acidophilus to produce lactic acid, and Bifidobacterium animalis subsp. lactis to produce, in addition to lactic acid, also acetic and succinic acids);
- they produce metabolites toxic to pathogenic bacteria (such as H₂O₂ formation);
- they produce substances with antibacterial activity—bacteriocins (Lactobacillus acidophilus synthesizes acidocin, a broad-spectrum bacteriocin that inhibits the growth of bacteria and fungi);
- they compete with pathogenic bacteria for nutrients;
- by binding to enterocyte receptors, they prevent colonization by pathogenic microorganisms.
The bacterial strains contained in the product also stimulate both specific and non-specific immune systems.
Disruption of the intestinal microflora balance (e.g., due to viral and bacterial intestinal infections, treatment with broad-spectrum antibiotics and chemotherapeutic agents, or abdominal and pelvic irradiation), or delayed establishment of normal microflora in newborns, may lead to gastrointestinal disorders and be accompanied by bloating, diarrhea, and constipation.
The product reduces the frequency and severity of gastrointestinal symptoms (primarily diarrhea) associated with disturbances in normal intestinal microflora and helps maintain normal intestinal function.
Pharmacokinetics
After oral administration, lactic acid bacteria exert a local effect in the gastrointestinal tract.
Due to the absence of systemic absorption, there are no available data on pharmacokinetic studies.
The resistance of Lactobacillus acidophilus and Bifidobacterium animalis subsp. lactis to gastric acid and bile ensures a high survival rate of these strains as they pass through the stomach and duodenum. Both lactic acid bacterial strains can adhere to the intestinal mucosa and, similar to other microorganisms present in the gastrointestinal tract, are gradually eliminated through peristalsis and defecation.
According to preclinical studies, including standard safety, toxicity, genotoxicity, carcinogenicity, and teratogenicity assessments, the product is safe for use.
Clinical characteristics.
Indications.
For the complex treatment of intestinal dysbiosis, and for the prevention and treatment of diarrhea, bloating, and other gastrointestinal disorders 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.
Interaction studies have not been conducted.
Lactic acid bacteria contained in the drug, like other bacteria, are sensitive to certain antibiotics. To enhance the effectiveness of the drug, it is recommended to take Linex Forte® capsules 3 hours after taking antibiotics.
Special precautions for use.
Before starting treatment with Linex forte®, consult a physician in the following cases:
- body temperature above 38 °C;
- presence of occult blood or mucus in stool;
- duration of diarrhea exceeding 2 days;
- severe diarrhea associated with dehydration and weight loss;
- diarrhea accompanied by severe abdominal pain.
Use with caution in:
- patients with severe underlying conditions (e.g., structural heart disease, presence of central venous catheters),
- patients receiving immunosuppressive therapy,
- patients with immunodeficiency (e.g., HIV infection),
- patients with impaired intestinal barrier function (e.g., short bowel syndrome),
- patients with chronic diseases (e.g., diabetes mellitus, cardiovascular diseases), as the safety of lactic acid bacteria in these patient groups has not been sufficiently studied, and there have been isolated reports of severe complications following their use.
When self-treating diarrhea, the first and most important step is to replenish lost fluids and electrolytes. Diarrhea in children under 6 years of age should be treated only under medical supervision.
The product contains oligofructose (glucose + fructose + sucrose) and possibly residual lactose; therefore, it should not be administered to patients with rare hereditary fructose intolerance, glucose-galactose malabsorption syndrome, lactase deficiency, or sucrase-isomaltase deficiency.
The product contains residual milk protein, which may provoke allergic reactions.
Use during pregnancy or breastfeeding.
There are no reports of adverse effects associated with the use of the product during pregnancy or breastfeeding. However, in cases of severe diarrhea, precautionary measures should be taken to prevent fluid and electrolyte depletion or other adverse effects that could endanger the fetus or the pregnant woman. Symptom relief of diarrhea during pregnancy or breastfeeding should be managed under medical supervision. Since sufficient data on the use of the product during pregnancy or breastfeeding are lacking, its use during these periods is not recommended.
Fertility: data are lacking.
Ability to influence reaction rate when driving or operating machinery.
Data are lacking.
Dosage and Administration.
Children aged 1 to 2 years: 1 capsule once daily.
Children aged 2 to 12 years: 1 capsule 1–2 times daily (depending on the severity of symptoms).
Adults and children aged 12 years and older: 1 capsule 1–3 times daily (depending on the severity of symptoms).
Children under 6 years of age should be treated for diarrhea under medical supervision.
Use of the drug is not recommended in infants under 1 year of age. For this age group, Linex baby®, powder for oral suspension, is recommended.
If a patient is unable to 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 ensure maximum effectiveness, the drug should be taken during meals. Linex Forte® capsules should not be taken with alcohol or hot beverages.
The drug should be taken until the patient's condition improves.
The duration of treatment depends on the underlying cause of the disease and individual patient characteristics.
If diarrhea persists for 2 days despite taking the drug, a doctor should be consulted.
When treating diarrhea, special attention should be paid to replenishing lost fluids and electrolytes.
Children.
Used in pediatric practice (see section "Dosage and Administration").
Overdose.
No cases of overdose have been reported.
Side effects.
Side effects are very rare (≤ 1:10,000).
Immune system disorders: possible hypersensitivity reactions, including rash, itching.
Shelf life. 3 years.
Storage conditions
Store at a temperature not exceeding 25 °C in the original packaging.
Keep out of reach of children.
Packaging
7 capsules in a blister; 1 (7 × 1), 2 (7 × 2), or 4 (7 × 4) blisters per cardboard box.
Prescription status
Over-the-counter (without prescription).
Manufacturer
Lek Pharmaceuticals d. d., Slovenia (responsible for batch release).
Manufacturer's address
Verovskova 57, 1526 Ljubljana, Slovenia.