Instructions for Enterol 250 powder for oral use No. 10
Composition
active ingredient: 1 sachet contains Saccharomyces boulardii CNCM I-745 (lyophilized cells) 250 mg;
Excipients: lactose monohydrate, fructose, colloidal anhydrous silica, tutti frutti flavoring.
Dosage form
Powder for oral use.
Main physicochemical properties: light brownish powder with a characteristic fruity 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; antitoxic action is due to the production of proteases that break down the toxin and the enterocyte receptor to which the toxin binds (especially with respect to cytotoxin A, Clostridium difficile); antisecretory action is due to the reduction of cAMP in enterocytes, which leads to a decrease in the secretion of water and sodium into the intestinal lumen; strengthening of nonspecific immune defense due to increased production of IgA and secretory components of other immunoglobulins; enzymatic action is due to increased activity of small intestinal disaccharidases (lactase, sucrase, maltase); trophic effect on the small intestinal mucosa 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 antibiotics. 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 precautions
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, or 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.
The drug contains fructose, so this drug should not be prescribed to patients with fructose intolerance.
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
No clinically significant malformative or fetotoxic effects have been identified to date. Monitoring of pregnancy in women taking this drug is not sufficient to exclude any risk. Therefore, as a precautionary measure, it is advisable to avoid the use of the drug during pregnancy.
During breastfeeding, the drug can be used under medical supervision.
The ability to influence the reaction speed when driving or working with other mechanisms
Does not affect.
Method of administration and doses
The dose and duration of treatment are determined by the doctor depending on the nature and course of the disease.
Newborns: no more than 1 sachet per day under the supervision of a doctor.
Children under 6 years of age: 1 sachet 1-2 times a day.
Adults and children over 6 years of age should take 1-2 sachets 1-2 times a day.
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 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 sachet 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.
Mix the contents of the sachet with milk or water.
Children
Apply to children of all age groups.
Overdose
Not described.
Side effects
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 sachets in a cardboard box.
Vacation category
Without a prescription.
Producer
BIOCODEX.
Address
Registered office: 7 avenue Gallieni 94250 Gentilly – France.
Production address: 1 avenue Blaise Pascal, 60000 Beauvais, France.
