Properties
What is it?
ENTEROLE 250 POWDER FOR ORAL SUSPENSION COMPOSITION Active substance: Yeast Saccharomyces boulardii CNCM I 745 (lyophilized cells) 250 mg. Excipients: Lactose monohydrate, fructose, anhydrous colloidal silica, "Tutti-Frutti" flavor (flavoring substance, maltodextrin (corn), sorbitol syrup E420, gum arabic/acacia gum E414, butylated hydroxyanisole E320, methyl eugenol, safrole). Pharmacological group: Antidiarrheal microorganisms. ATC code: A07FA02 See blogs: Enterol and its mechanism of action in treating diarrhea What is dysbacteriosis — types and symptoms of the disease USE Saccharomyces boulardii CNCM I 745 is a probiotic, meaning it is a microorganism beneficial to the body. Intestinal flora consists of billions of microorganisms. Its balance is necessary to maintain certain important functions of the gastrointestinal tract (GIT), such as food processing, fighting infectious agents, and stimulating and strengthening immune defense. However, this balance is fragile and can be disrupted by many factors, such as intestinal infections caused by viruses or bacteria, treatment with certain drugs, for example, antibiotics; changes in dietary habits, which can cause various digestive problems, such as diarrhea. Enterol 250, powder for oral suspension is a "substitute flora" preparation that allows for the compensation of transient imbalances in the intestinal flora. INDICATIONS • Acute diarrheal infection in children and adult patients; • Acute and chronic enteritis and enterocolitis; • Treatment and prevention of antibiotic-induced diarrhea; as an adjunct to vancomycin/metronidazole treatment for the prevention of recurrence of Clostridium difficile disease; • Intestinal dysbacteriosis; • Irritable bowel syndrome; • Diarrhea associated with prolonged tube feeding. CONTRAINDICATIONS ENTEROLE 250 POWDER FOR ORAL SUSPENSION MUST NOT BE USED IN THE FOLLOWING CASES: • Allergy to Saccharomyces boulardii CNCM I 745 or any other ingredient of the preparation (listed in the composition); • During central venous catheterization (see Precautions); • Immunocompromised or hospitalized patients (with serious illness or altered/weakened immune system). PRECAUTIONS • To avoid colonization, it is not recommended to open the powder for oral suspension in the presence of patients with a central venous catheter, especially in the case of an arm venous catheter. In patients with central venous catheterization, even those not treated with Saccharomyces boulardii CNCM I 745, very rare cases of fungemia (yeast invasion of the blood) have been observed; this complication most often caused fever and positive blood culture for Saccharomyces. In all these cases, resolution was achieved after administration of satisfactory antifungal treatment and, if necessary, after removal of the catheter. • When used as an adjunct to treatment, the following dietary rules must be followed: • To compensate for fluid loss due to diarrhea, rehydrate with abundant, salty or sweetened water (average daily water intake for adults is 2 liters); • Specific products, particularly fruits, green vegetables, spicy foods, as well as frozen foods and drinks, should be excluded. • Immediate medical consultation is required in the following cases: • Lack of improvement within 2 days of treatment; • Fever, vomiting; • Presence of blood or mucus in the stool; • Intense thirst or dry tongue: these signs indicate the onset of dehydration, meaning significant fluid loss due to diarrhea. The doctor will decide on the need for rehydration orally or intravenously. OTHER MEDICINES AND ENTEROL 250, POWDER FOR ORAL SUSPENSION Tell your doctor or pharmacist if you have taken, are taking, or might take any other medicines. Do not use this preparation with other oral antifungal preparations (anti-fungal drugs). ENTEROLE 250, POWDER FOR ORAL SUSPENSION WITH FOOD AND DRINK This preparation contains live cells. Therefore, it should not be mixed with hot (above 50°C) or iced or alcoholic beverages and foods, as the yeast may be destroyed under these conditions. PREGNANCY AND LACTATION Due to the lack of sufficient data, the use of this preparation is not recommended during pregnancy. Under normal conditions of use, this preparation can be taken during lactation. If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. ENTEROLE 250, POWDER FOR ORAL SUSPENSION CONTAINS FRUCTOSE The preparation contains 471.90 mg of fructose per sachet. Frequent or prolonged use (e.g., two weeks or more) of fructose may cause dental damage. If your doctor has told you that you or your child have an intolerance to some sugars or have been diagnosed with hereditary fructose intolerance (HFI) (a rare genetic disease in which fructose is not broken down in the body), talk to your doctor before taking the medicine. ENTEROLE 250, POWDER FOR ORAL SUSPENSION CONTAINS LACTOSE MONOHYDRATE This preparation is contraindicated in patients with congenital galactosemia, glucose or galactose malabsorption, or lactase deficiency. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before using this medicinal product. ENTEROLE 250, POWDER FOR ORAL SUSPENSION CONTAINS SORBITOL The preparation contains 0.10 mg of sorbitol per sachet. DOSAGE AND ADMINISTRATION Newborns: Not more than 1 sachet per day, under strict medical supervision. Children under 6 years of age: 1 sachet 1-2 times a day. Adults and children over 6 years of age: 1-2 sachets 1-2 times a day. Recommended duration of treatment: • Treatment of acute diarrhea: 3-5 days. • Treatment of dysbacteriosis, chronic diarrhea, irritable bowel syndrome: 10-14 days. • Prevention and treatment of antibiotic-associated diarrhea and pseudomembranous colitis: Enterol 250, powder for oral suspension is taken with antibiotics, 2 sachets per day, starting from the first intake of antibiotics. Always use this medicine exactly as described in the accompanying information or as prescribed by your doctor or pharmacist. Check with your doctor or pharmacist if you are unsure about anything. METHOD AND ROUTE OF ADMINISTRATION Oral Pour the contents of the sachet into a small amount of water or sweet drink, stir and drink. The powder can also be mixed with food. Do not pour or mix into very cold or very hot solutions or food or non-alcoholic beverages. MISSED DOSE Do not take a double dose to make up for a missed sachet. OVERDOSE No measures are necessary in case of overdose. POSSIBLE SIDE EFFECTS Like all medicines, this medicine can cause side effects, although not everyone gets them. Rarely (occurs in 1 in 1000 people): A few cases of bloating. Very rarely (occurs in 1 in 10,000 people): Invasion of yeasts into the blood (fungemia). There are some reports of allergies, itching, urticaria, skin rash, and angioedema. Some cases of anaphylactic reactions and shock have also been reported. Unknown frequency: Constipation and serious blood infections (sepsis) in severely ill or immunocompromised patients. If you notice any side effects, consult your doctor or pharmacist. This includes any side effects not listed above. STORAGE CONDITIONS Store the preparation in a place invisible and inaccessible to children. Do not use after the expiry date indicated on the cardboard packaging. Store protected from light at a temperature not exceeding 25°C. Shelf life: 3 years. Do not dispose of any medicines in drains or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. These measures are aimed at protecting the environment. APPEARANCE AND PACKAGING Powder contained in twin sachets. Each sachet consists of paper/aluminum foil/polyethylene film, containing 765 mg of light brown powder with a fruity smell. 10 sachets per pack. DISPENSING FORM: Over-the-counter