Instructions Linex forte capsules blister No. 7
Composition
active ingredients: 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), iron oxide yellow (E 172).
Dosage form
The capsules are hard.
Main physicochemical properties: capsules No. 2, white body, yellow cap; capsule contents: powder from light beige to light pink with darker inclusions.
Pharmacotherapeutic group
Antidiarrheal microbial drugs. ATX code A07F A01.
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.
There are several mechanisms by which they exert their inherent preventive and therapeutic effects, preventing the growth of pathogenic bacteria:
affect the reduction of 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);
produce metabolites that are toxic to pathogenic bacteria (formation of H2O2);
produce substances with antibacterial activity, bacteriocins (Lactobacillus acidophilus synthesizes acidocin, a broad-spectrum bacteriocin that inhibits the growth of bacteria and fungi);
compete with pathogenic bacteria for nutrients; by binding to enterocyte receptors, they prevent colonization of pathogenic microorganisms.
The strains of bacteria that make up the preparation also stimulate the specific and nonspecific immune system.
Disruption of the balance of intestinal microflora (for example, due to viral and bacterial intestinal infections, treatment with broad-spectrum antibiotics and chemotherapeutic agents, irradiation of the abdominal and pelvic organs) or delayed formation of normal microflora in newborns can lead to gastrointestinal disorders and be accompanied by flatulence, diarrhea and constipation.
Reduces the frequency and severity of digestive tract symptoms (mainly diarrhea) associated with disruption of the normal intestinal microflora, and ensures its normal function.
Pharmacokinetics
After oral administration, lactic acid bacteria have a local effect in the digestive tract.
Due to the lack of systemic absorption, there are no pharmacokinetic data.
The resistance of Lactobacillus acidophilus and Bifidobacterium animalis subsp. lactis to gastric acid and bile results in a high degree of survival of these strains during passage through the stomach and duodenum. Both strains of lactic acid bacteria can adsorb to the intestinal mucosa and, like other microorganisms present in the digestive tract, are gradually excreted during peristalsis and defecation.
According to preclinical studies, including conventional studies on safety, toxicity, genotoxicity, carcinogenicity, teratogenicity, the drug is safe for use.
Indication
For the complex treatment of intestinal dysbiosis, for the prevention and treatment of diarrhea, bloating and other digestive tract disorders caused by:
viral or bacterial infections of the digestive tract (e.g., rotavirus infection, traveler's diarrhea); use of antimicrobial agents (antibiotics or other synthetic antimicrobial drugs).
Contraindication
Hypersensitivity to the components of the drug.
Interaction with other medicinal products and other types of interactions
Interaction studies have not been conducted.
Lactic acid bacteria, which are part of the drug, like other bacteria, are sensitive to some antibiotics. To increase the effectiveness of the drug, it is recommended to take Linex forte® capsules 3 hours after taking antibiotics.
Application features
Before starting to use Linex forte®, you should consult a doctor in the following cases:
body temperature above 38 °C; presence of occult blood or mucus in the stool; duration of diarrhea for more than 2 days; intense diarrhea with dehydration and weight loss; diarrhea accompanied by severe abdominal pain; presence of other chronic diseases (e.g., diabetes, cardiovascular diseases) or immunodeficiency (e.g., HIV infection).
When self-treating diarrhea, the first and main measure is to replenish lost fluids and electrolytes. Children under 6 years of age should only be treated for diarrhea under the supervision of a doctor.
1 capsule of the drug contains 29.1 mg of anhydrous glucose and 10.29-17.15 mg of oligofructose, therefore patients with rare hereditary fructose intolerance, glucose-galactose malabsorption syndrome or sucrase-isomaltase insufficiency should not take this medicine.
The drug contains milk protein residues, which may cause allergic reactions.
Ability to influence reaction speed when driving vehicles or other mechanisms
Data is missing.
Use during pregnancy or breastfeeding
There are no reports of adverse effects when using the drug during pregnancy or breastfeeding. However, in case of severe diarrhea, precautions should be taken to avoid fluid and electrolyte depletion or other adverse effects that may be dangerous to the fetus or pregnant woman. Relief of diarrhea symptoms in pregnant women and during breastfeeding should be carried out under the supervision of a physician. Since there is insufficient data on the use of the drug during pregnancy or breastfeeding, its use is not recommended during these periods.
Method of administration and doses
Children aged 1 to 2 years: 1 capsule once a day.
Children aged 2 to 12 years: 1 capsule 1-2 times a day (depending on the severity of symptoms).
Adults and children over 12 years of age: 1 capsule 1-3 times a day (depending on the severity of symptoms).
Children under 6 years of age should be treated for diarrhea under the supervision of a physician.
The use of the drug for the treatment of infants under 1 year of age is not recommended. For this age group, it is recommended to use Linex baby®, powder for oral suspension.
If the patient cannot swallow the capsule whole, it should be opened and the contents of the capsule mixed with a teaspoon of liquid (tea, juice, sweetened water). The resulting mixture should not be stored.
To ensure maximum effectiveness, the drug is recommended to be taken with food. Linex forte® capsules should not be taken with alcohol or hot drinks.
The drug should be taken until the patient's condition improves.
The duration of treatment depends on the cause of the disease and the individual characteristics of the body.
If diarrhea does not go away within 2 days, despite taking the drug, you should consult a doctor.
When treating diarrhea, special attention should be paid to replenishing lost fluids and electrolytes.
Children
Used in pediatric practice (see section "Method of administration and dosage").
Overdose
There are no reports of overdose.
Adverse reactions
Side effects are very rare (≤ 1:10,000). Hypersensitivity reactions, including rash, itching, are possible.
Expiration date
2 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 blister in a cardboard box.
Vacation category
Without a prescription.
Producer
Lek Pharmaceutical Company Ltd., Slovenia.
Location of the manufacturer and its business address
Verovškova 57, Ljubljana 1526, Slovenia.
