Instructions Enterol 250 capsules No. 30
Composition
active ingredient: 1 capsule contains Saccharomyces boulardii CNCM I-745 (lyophilized cells) 250 mg;
excipients: lactose monohydrate, magnesium stearate.
Dosage form
Capsules.
Main physicochemical properties: opaque white gelatin capsules containing a light brown powder with a specific odor.
Pharmacotherapeutic group
Antidiarrheal microbial drugs. Saccharomyces boulardii.
ATX code A07F A02.
Pharmacological properties
Pharmacodynamics.
Enterol 250 normalizes the intestinal microflora and has a pronounced etiopathogenetic antidiarrheal effect. During the passage through the gastrointestinal tract, Saccharomyces boulardii CNCM I-745
have a biological protective effect on normal intestinal microflora.
The main mechanisms of action of Saccharomyces boulardii CNCM I-745:
– direct antagonism (antimicrobial action), due to the ability of Saccharomyces boulardii CNCM I-745 to inhibit the growth of pathogenic and opportunistic microorganisms and fungi that disrupt the intestinal biocenosis, such as: Clostridium difficile, Clostridium pneumoniae, Staphylococcus aureus, Pseudomonas aeruginosa, Candida krusei, Candida pseudotropical, Candida albicans, Salmonella typhi, Salmonella enteritidis, Escherichia coli, Shigella dysenteriae, Shigella flexneri, Klebsiella, Proteus, Vibrio cholerae, as well as Enthamoeba hystolitica, Lambliae; Enterovirus, Rotavirus;
– the antitoxic effect is due to the production of proteases that break down the toxin and act on the enterocyte receptor to which the toxin binds (especially with respect to cytotoxin A, Clostridium difficile);
– antisecretory effect is due to a decrease in cAMP in enterocytes, which leads to a decrease in the secretion of water and sodium into the intestinal lumen;
– strengthening of nonspecific immune defense by increasing the production of IgA and secretory components of other immunoglobulins;
– enzymatic action is due to increased activity of disaccharidases of the small intestine (lactase, sucrase, maltase);
– the trophic effect on the mucous membrane of the small intestine is observed due to the release of spermine and spermidine.
The genetically determined resistance of Saccharomyces boulardii CNCM I-745 to antibiotics justifies the possibility of their simultaneous use with antibiotics to protect the normal biocenosis of the digestive tract.
Pharmacokinetics.
After taking the drug, a high concentration of Saccharomyces boulardii CNCM I-745 in the large intestine is quickly achieved, which is maintained for 24 hours. Saccharomyces boulardii CNCM I-745 does not penetrate the systemic bloodstream and mesenteric lymph nodes. After the end of treatment, Saccharomyces boulardii CNCM I-745 is completely excreted in the feces within
3–5 days.
Indication
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 diseases caused by Clostridium difficile.
Diarrhea associated with long-term enteral nutrition.
Contraindication
Hypersensitivity to any component of the drug. The drug is contraindicated in patients with a central or peripheral venous catheter; patients undergoing treatment in an intensive care unit; immunocompromised patients, such as: HIV-infected, cancer patients, organ transplant patients, receiving chemotherapy and/or radiation therapy and/or prolonged high doses of corticosteroids.
Special safety measures.
If symptoms of the disease are observed for more than 2 days of treatment at the usual dosage, a doctor's consultation and correction of the dosage of the drug are necessary.
Enterol 250 contains a live culture. Therefore, the drug should not be mixed with very hot
(over 50 °C) or cold drinks, liquids containing alcohol, with very hot or cold food.
Treatment is not a substitute for rehydration when necessary. The volume of rehydration and the route of administration (oral/intravenous) should be appropriate for the severity of the diarrhea, the age, and the general condition of the patient.
Capsules should not be opened in the presence of patients who are immunocompromised or in intensive care units, or who have central and/or peripheral venous catheters in place, to prevent colonization, particularly by mechanical transfer during catheter manipulation. There is evidence that patients with central venous catheters who have not received S. boulardii CNCM I-745 have very rarely developed fungemia (infection of the blood with yeast), most often with fever and positive blood cultures for Saccharomyces. The treatment outcome in all these cases was satisfactory with antifungal therapy and, if necessary, catheter removal. Due to the risk of airborne contamination, capsules should not be opened in patient rooms. When preparing probiotics for administration, healthcare personnel should wear disposable medical gloves. Gloves should be discarded after use. Healthcare personnel should perform hand hygiene. The drug contains lactose, therefore patients with rare hereditary forms of galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome should not use the drug.
Interaction with other medicinal products and other types of interactions
Do not take simultaneously with antifungal agents when used orally or in combination.
Use during pregnancy or breastfeeding
Currently, no clinically significant malformative and fetotoxic effects have been identified.
Pregnancy monitoring in women taking this drug is not sufficient to exclude any risk. Therefore, as a precautionary measure, it is preferable to avoid use of the drug during pregnancy.
During breastfeeding, the drug can be used under medical supervision.
Ability to influence reaction speed when driving vehicles or other mechanisms
Does not affect.
Method of administration and doses
Adults and children over 6 years of age should take 1-2 capsules 1-2 times a day. The maximum daily dose is 4 capsules.
Recommended treatment duration
- acute diarrhea: 3-5 days;
- treatment of dysbiosis, chronic diarrheal syndrome, irritable bowel syndrome:
10-14 days;
- prevention and treatment of antibiotic-associated diarrhea and pseudomembranous colitis: Enterol 250 should be taken in regimens together with an antibiotic from the first day of use until the end of antibiotic treatment;
- traveler's diarrhea: start of use: 5 days before arrival, 1 capsule per day throughout the trip; end of use: on the day of arrival from the country of travel. The drug should be used every morning on an empty stomach. The maximum period of use is 30 days.
It is recommended to take the capsules with water.
Children
Use in children over 6 years of age. For children under 6 years of age, it is recommended to take Enterol 250 in the form of a lyophilized powder for oral administration.
Overdose
Not described.
Adverse reactions
In individuals with individual intolerance to any component of the drug, hypersensitivity reactions are possible, including skin rashes, itching, exanthema, urticaria, anaphylactic reactions, angioedema, anaphylactic shock, constipation with an unknown frequency, flatulence, epigastric discomfort. Very rarely, there is a risk of fungemia in hospitalized patients with a central or peripheral venous catheter.
Expiration date
3 years.
Storage conditions
Store in the original packaging out of the reach of children at a temperature not exceeding 25 °C.
Packaging
10 or 20, 30 or 50 capsules in a glass bottle with a polyethylene cap with PVC film to control the first opening; 1 glass bottle in a cardboard box;
5 capsules in a blister; 2 or 4 or 6 blisters in a cardboard box;
6 capsules in a blister; 5 blisters in a cardboard box.
Vacation category
Without a prescription.
Producer
BIOCODEX.
Location of the manufacturer and address of its place of business
Registered office: 7 avenue Gallieni 94250 Gentilly – France.
Production address: 1 avenue Blaise Pascal, 60000 Beauvais, France.
