Composition
1 sachet contains:
Active ingredient:
freeze-dried Saccharomyces boulardii 250 mg.
Auxiliary substances:
lactose monohydrate 13 mg,
fructose 188.76 mg,
colloidal silicon dioxide 2.5 mg,
tutti-frutti flavor 1.74 mg
Pharmacological action
Pharmacotherapy group: An antidiarrheal agent. ATX code: A07FA02 Pharmacological properties: Pharmacodynamics : Saccharomyces boulardii is a probiotic. Saccharomyces boulardii has an antimicrobial effect due to its antagonistic effect against pathogenic and opportunistic microorganisms: Clostridium difficile, Candida albicans, Candida kruesei, Candida pseudotropicalis, Klebsiella pneumoniae, Pseudomonas aeruginosa, Salmonella typhimurium, Yersinia enterocolitica, Escherichia coli, Shigella dysenteriae, Staphylococcus aureus and others, as well as Entamoeba histolitica and Lambliae. Saccharomyces boulardii has an antitoxin effect against bacterial cyto-and enterotoxins, increases the enzymatic function of the intestine. A component of the Saccharomyces boulardii cell wall, mannitol is a substrate for pathogenic strains of Escherichia coli and Salmonella typhimurium, which causes their adhesion (attachment) to the surface of Saccharomyces boulardii and subsequent elimination from the body. Saccharomyces boulardii is naturally resistant to antibiotics. Pharmacokinetics: Saccharomyces boulardii is not a eubiotic, as it is not a component of the normal intestinal microflora. Saccharomyces boulardii does not reproduce in the digestive tract and is completely eliminated from the body within 2-5 days after discontinuation of ingestion.
Indications
Auxiliary symptomatic treatment and prevention of diarrhea of various etiologies in adults and children over 1 year of age, including dysbiosis, irritable bowel syndrome, enterocolitis, antibiotic-associated diarrhea, traveler’s diarrhea, diarrhea caused by Clostridium difficile, used in addition to rehydration.
Use during pregnancy and lactation
The use of Enterol during pregnancy and lactation is justified only if the expected benefit of therapy for the mother exceeds the potential risk to the fetus or child.
Contraindications
-Hypersensitivity to any of the components of the drug, in particular to lactose or fructose (contains both components). – Lactose, galactose intolerance, lactase deficiency (such as Lapp), or glucose, galactose, or fructose malabsorption syndrome (rare hereditary problems). – The patient has a central venous catheter.
Side effects
Immune system disorders Rare: urticaria. Very rare: allergic reactions (up to angioedema), rash, itching. Disorders of the gastrointestinal tract Often: constipation, gas formation. Disorders of the nervous system Often: headache, feeling hot.
Interaction
When used concomitantly with oral antifungal agents, the clinical efficacy of Enterol is reduced (this combination is not recommended).
How to take, course of use and dosage
For oral use. Take 2-8 sachets a day 1 hour before meals. The contents of the sachet are stirred in a glass of water or other beverage at room temperature. Children from 1 to 3 years – 1-3 sachets twice a day. Children from 3 years and adults – 2-4 sachets twice a day. 3 Enterol ® contains live cells that are activated at 37 °C, so the drug should not be mixed with liquids or foods that are too hot (above 50 °C), cold, or containing alcohol. For the treatment of acute diarrhea of viral, bacterial or protozoal etiology, the course of treatment is 5-10 days. In the prevention of antibiotic-associated diarrhea, the duration of use corresponds to the course of use of the antibiotic. In the prevention of recurrent infections caused by Clostridium difficile, in combination with metronidazole or vancomycin, the duration of use is 1 month. In the prevention of traveler’s diarrhea, the duration of application corresponds to the duration of travel. For the treatment of irritable bowel syndrome, the drug should be continued until symptoms disappear. Taking the drug for the treatment of acute diarrhea must necessarily be accompanied by rehydration (heavy drinking).
Overdose
Overdose of the drug is impossible due to its pharmacokinetic properties.
Special instructions
It is necessary to use the drug with caution in people with immunodeficiency. Do not drink hot or alcoholic beverages. Do not heat the preparation mixed in water or other beverage in a microwave oven (microwave oven). Water or drink, if necessary, is heated in a microwave oven, and then the drug is added to warm water. If after two days of using Enterol® for the treatment of acute diarrhea, there is no improvement, as well as if the temperature rises, blood or mucus is found in the feces, you should immediately consult your doctor. A feeling of thirst and dry mouth indicates insufficient fluid intake (rehydration). Unsuitable for use is a drug whose packaging integrity is broken, a drug without labeling, or a drug with altered physical properties. Effect on the ability to drive vehicles and mechanisms: No adverse effects of the use of Enterol® on the ability to drive a car and complex mechanisms were observed.
Form of production
Powder for the preparation of a suspension for oral use of 100 mg. 306 mg of the powder is placed in a paper-polyethylene-aluminum bag. 10,14 or 20 sachets together with the instructions for use are placed in a cardboard pack. 10 sachets are placed in a cardboard pack without the upper edge and 2 or 5 such packs are placed in a cardboard pack together with the instructions for use.
Storage conditions
The drug should be stored out of the reach of children at a temperature not exceeding 20 °C.
Shelf
life is 3 years.
Active ingredient
Saccharomyces Boulardil
Dosage form
suspension for oral use
Description
Children over 1 year of age, Nursing mothers as prescribed by a doctor, Pregnant women as prescribed by a doctor, For adults
Indications
Salmonellosis, Dysbiosis, Poisoning, Diarrhea, Colitis, Intestinal infections
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Side effects of Enterol, oral suspension pore 100mg bag. 20pcs.
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