Instructions for Normagut capsules No. 10
Composition
active ingredient: lyophilized dry yeast Saccharomyces boulardii;
1 capsule contains 250 mg of lyophilized dry yeast Saccharomyces boulardii with a minimum of 1010 cells/g, which includes: 221.25 mg of yeast and 28.75 mg of lactose monohydrate;
Excipients: anhydrous lactose, magnesium stearate, gelatin, titanium dioxide (E 171), yellow iron oxide (E 172), copper complexes of chlorophyllins (E 141), purified water.
Dosage form
Capsules.
Main physicochemical properties: oblong, shiny, opaque, hard gelatin capsules with a light green body and a yellow cap. The capsules contain a granular yellow-gray powder with a characteristic odor.
Pharmacotherapeutic group
Antidiarrheal microbial drugs. ATX code A07F A02.
Pharmacological properties
Pharmacodynamics.
Normagut helps restore normal intestinal microflora, has a pronounced etiopathogenetic antidiarrheal effect. When passing through the digestive tract, Saccharomyces boulardii has a biological protective effect on normal intestinal microflora.
The main mechanisms of action of Saccharomyces boulardii:
direct antagonism (antimicrobial action) associated with the ability of Saccharomyces boulardii to inhibit the growth of pathogenic and opportunistic microorganisms and fungi that disrupt the intestinal microbiota, 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 (reduces the secretion of water and salts into the intestinal lumen) is provided by reducing the formation of cAMP in enterocytes;
strengthening of nonspecific immune defense due to increased production of IgA and secretory components of other immunoglobulins;
enzymatic activity is due to increased activity of small intestinal disaccharidases (lactase, sucrase, maltase);
trophic effect on the mucous membrane of the small intestine due to the release of spermine and spermidine.
The genetically determined resistance of Saccharomyces boulardii to antibiotics allows it to be used simultaneously with antibiotics to protect the normal microbiocenosis of the digestive tract.
Pharmacokinetics.
After taking Normagut, a high concentration of Saccharomyces boulardii in the large intestine is quickly achieved, which is maintained throughout the day. Saccharomyces boulardii do not penetrate the systemic bloodstream and mesenteric lymph nodes. After the end of treatment, Saccharomyces boulardii are completely excreted with 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.
Traveler's diarrhea.
Irritable bowel syndrome.
Pseudomembranous colitis and diseases caused by Clostridium difficile.
Diarrhea associated with long-term enteral nutrition.
Contraindication
Hypersensitivity to yeast or to any of the components of the medicinal product.
Contraindicated in patients with an indwelling central venous catheter.
Interaction with other medicinal products and other types of interactions
Do not take simultaneously with antifungal agents when used orally or in combination.
When used simultaneously with monoamine oxidase inhibitors (MAOIs), an increase in blood pressure is possible.
Application features
If diarrhea lasts longer than 2 days or there is blood in the stool, or there is an increase in body temperature, you should consult a doctor.
In gastrointestinal diseases, especially in children, it is necessary to use sufficient amounts of fluid and electrolytes as the most important therapeutic measures.
Saccharomyces boulardii is a living organism that, under adverse conditions, such as in immunocompromised patients, can cause systemic fungal infections associated with mechanical transfer of yeasts from the gastrointestinal tract into the blood or through a central venous catheter. Isolated cases of such fungal infections may occur in patients who have had a central venous catheter and at the same time were being treated for a gastrointestinal disease.
Due to the risk of systemic colonization by Saccharomyces boulardii in patients with a weakened immune system (e.g. HIV infection, organ transplantation, leukemia, malignant tumors, radiation therapy, chemotherapy, prolonged use of high doses of corticosteroids), Normagut should be used only after consulting a doctor.
The drug contains lactose, therefore patients with rare hereditary forms of galactose intolerance, lactase deficiency, or glucose-galactose malabsorption syndrome are not recommended to use the drug.
Use during pregnancy or breastfeeding
No clinically significant malformative or phytotoxic effects have been identified to date. Monitoring of pregnancy in women who have taken 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.
Ability to influence reaction speed when driving vehicles or other mechanisms
Does not affect.
Method of administration and doses
It is taken internally, washed down with sufficient water.
Adults and children over 12 years of age should take 1–2 capsules 1–2 times a day.
Children aged 2 to 12 years: 1 capsule 1–2 times a day.
For children under 6 years of age, open the capsule and pour its contents into 50 ml of water at room temperature (20–25 °C). The capsule should be opened and its contents mixed with water immediately before use.
The dose and duration of treatment are determined by the doctor depending on the nature and course of the disease.
Recommended treatment times:
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: Normagut should be taken in regimens together with an antibiotic from the first day of use until the end of antibiotic treatment.
Traveler's diarrhea: 1 capsule per day. Use should begin 5 days before arrival in the country of travel and continue throughout the trip until the day of arrival from the country of travel. The drug should be taken every morning on an empty stomach. The maximum duration of use is 30 days.
Children.
Normagut is used for children aged 2 years and older.
Overdose
If the therapeutic dose is slightly exceeded, it does not cause any negative reactions. If the dose is significantly exceeded, flatulence, nausea, vomiting or increased manifestations of adverse reactions may occur.
Treatment: gastric lavage, administration of activated charcoal and/or symptomatic therapy.
Side effects
On the part of the digestive tract: short-term discomfort in the epigastrium, not requiring discontinuation of the drug, bloating.
In case of individual intolerance to the drug, hypersensitivity reactions are possible, including skin rashes, itching, local and generalized exanthema, angioedema, shortness of breath, anaphylactic shock, urticaria, anaphylactic reactions. If allergic reactions occur, discontinue use of the drug.
Expiration date
2 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C, out of the reach of children.
Packaging
10 capsules in a blister; 1 or 3 blisters in a cardboard box.
Vacation category
Without a prescription.
Producer
Ardeypharm GmbH/Ardeypharm GmbH.
Address.
Loerfeldstrasse 20, 58313 Herdecke, North Rhine-Westphalia, Germany.
