Instructions Linex hard capsules No. 32
Composition
active ingredients: 1 capsule contains at least 1.2 × 107 CFU of antibiotic-resistant lactic acid bacteria: at least 4.5 × 106 CFU of Lactobacillus acidophilus (sp. L. gasseri), at least 3.0 × 106 CFU of Bifidobacterium infantis, at least 4.5 × 106 CFU of Enterococcus faecium;
excipients: lactose monohydrate, potato starch, dextrin, magnesium stearate;
shell: gelatin, titanium dioxide (E 171).
Dosage form
The capsules are hard.
Main physicochemical properties: capsule: white cap - white body, without inscription; capsule contents: white powder.
Pharmacotherapeutic group
Antidiarrheal microbial drugs. Code ATXA07F A01.
Pharmacological properties
Pharmacodynamics
Linex® is a combined preparation containing 3 different types of lyophilized viable lactic acid bacteria from different parts of the intestine, which are part of the normal intestinal flora, support and regulate the physiological balance of the intestinal microflora. The preventive and therapeutic effect of these microorganisms is provided by various mechanisms:
– lactose fermentation shifts the pH to an acidic environment. An acidic environment inhibits the growth of pathogenic and conditionally pathogenic bacteria and ensures optimal action of digestive enzymes;
– lactic acid bacteria synthesize vitamins B1, B2, B6, B12 and vitamin K;
– participate in the metabolism of bile acids and bile pigments;
– prevent the adhesion of pathogenic microorganisms to the intestinal wall;
– synthesize substances with antibacterial activity (bacteriocins);
– stimulate humoral immunity and local immunity in the intestine.
Disruption of the balance of lactic acid bacteria is possible for various reasons (viral and bacterial infections, foreign travel, use of broad-spectrum antibiotics and chemotherapeutic agents, irradiation of the abdominal cavity and pelvic organs).
Newborns may experience a delay in the formation of normal intestinal microflora. All this can lead to gastrointestinal disorders and be accompanied by flatulence, diarrhea, and constipation.
The use of Linex® capsules helps maintain normal intestinal microflora and restore the disturbed balance of microorganisms in the intestines.
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.
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 caused by:
– viral or bacterial infections of the digestive tract (e.g., rotavirus infection, traveler's diarrhea);
– the 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
Linex® capsules can be used simultaneously with antibiotics and chemotherapeutic agents. To increase the effectiveness of the drug, it is recommended to take Linex® capsules 3 hours after taking antibiotics and chemotherapeutic agents.
No clinically significant interactions with other drugs have been identified.
Application features
Before starting to use Linex®, you should consult a doctor in the following cases:
– body temperature above 38 °C;
– presence of hidden blood or mucus in the stool;
– duration of diarrhea more than 2 days;
– intense diarrhea with dehydration and weight loss;
– diarrhea accompanied by severe abdominal pain;
– the presence of other chronic diseases (e.g., diabetes, cardiovascular diseases) or immunodeficiency (e.g., HIV infection).
Children under 6 years of age should only be treated for diarrhea under the supervision of a doctor.
1 capsule of the drug contains 98.28 mg of lactose, therefore it should not be used in patients with rare hereditary problems of galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome.
The drug contains milk protein residues, which may cause allergic reactions.
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 a threat to the fetus or the pregnant woman. Treatment of diarrhea during pregnancy or breastfeeding should be carried out only under the supervision of a doctor. It is not recommended to take the drug during these periods, as there is insufficient data on its safe use.
Ability to influence reaction speed when driving vehicles or other mechanisms
Data is missing.
Method of administration and doses
Children aged 2 to 12 years: 1–2 capsules 3 times a day.
Adults and children over 12 years of age: 2 capsules 3 times a day.
Children under 6 years of age should be treated for diarrhea under the supervision of a physician.
If the child 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 prevent the adverse effect of gastric juice on lactic acid bacteria, it is recommended to take the drug with food. Linex® 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 stop within 2 days, despite taking the drug, you should consult a doctor.
With diarrhea, special attention should be paid to replenishing lost fluids and electrolytes.
Children
Use in pediatric practice.
Overdose
There are no reports of overdose.
Adverse reactions
Side effects are very rare (≤ 1:10,000). Hypersensitivity reactions, rash, itching are possible.
Expiration date
2 years.
After first opening the bottle – 4 months (for capsules in the bottle).
Storage conditions
Store at a temperature not exceeding 25 °C in the original packaging.
Keep the bottle tightly closed (for capsules in the bottle).
Keep out of reach of children.
Packaging
32 capsules per bottle; 1 bottle per carton.
8 capsules in a blister; 2 (8 × 2) or 4 (8 × 4) or 6 (8 × 6) blisters in a cardboard box.
Vacation category
Without a prescription.
Producer
Lek Pharmaceuticals d. d., Slovenia (responsible for the release of the series).
Location of the manufacturer and address of its place of business
Verovskova 57, 1526 Ljubljana, Slovenia.
