“Description
The active substance is freeze-dried yeast Saccharomyces boulardii, classified as probiotics, i.e. live microorganisms. The Enterol medicinal product restores the balance of intestinal flora.
Composition
The active substances of the drug are: freeze-dried yeast Saccharomyces boulardii CNCM I-745.
One capsule contains 250 mg of yeast.
Excipients: lactose monohydrate, magnesium stearate; gelatin capsule ingredients: gelatin, titanium dioxide.
Dosage
Always use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist.
Adults and children:
Acute infectious diarrhea: 1 to 2 capsules daily for up to 1 week.
Post-antibiotic diarrhea: 1 to 2 capsules a day, during and after antibiotic therapy.
Diarrhea caused by C. difficile infection: 4 capsules a day, for up to 4 weeks.
Diarrhea associated with enteral feeding: 1 to 2 capsules daily.
Traveler’s diarrhea: 1 to 4 capsules daily for up to 1 week.
Method of administration:
Use orally. The capsule should be swallowed with a glass of water. The capsule can be opened and its contents poured into a small amount of sweetened drink, food or added to a baby bottle.
The use of capsules is not recommended for children under 6 years of age due to the risk of choking; it is recommended to open the capsules and add their contents to a drink or food.
Action
The Enterol medicinal product has antidiarrheal properties. It maintains the balance of intestinal microflora, which is necessary to ensure important functions of the digestive tract, such as digestion, resistance to infections and strengthening of natural immunity.
Enterol is a drug that affects the intestinal flora, the so-called a “”substitute for natural flora”” that allows it to balance its temporary disturbance.
Indications
Enterol is used in: treatment of acute infectious diarrhea, prevention of post-antibiotic diarrhea, recurrent diarrhea caused by Clostridium difficile infection, as an addition to treatment with vancomycin or metronidazole, prevention of diarrhea associated with enteral nutrition, prevention of traveler’s diarrhea.
Contraindications
When not to use:
If you are allergic to the active substance or any of the other ingredients of this medicine.
If the patient has a central venous line inserted.
Patients with significantly reduced immunity or hospitalized (due to severe diseases or disorders (weakness) of the immune system).
Side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Rare (occurring in less than 1 in 1,000 but more than 1 in 10,000 people): a few cases of flatulence have been reported.
Very rare (occurring in less than 1 in 10,000 people): local rash, allergic reactions, hives, itching, anaphylactic reactions, facial swelling, angioedema, rash over the whole body (exanthema), penetration of yeast into the blood (fungemia).
Not known: (frequency cannot be estimated from the available data): constipation, severe blood infection (sepsis).
Warnings and precautions
Talk to your doctor or pharmacist before using Enterol.
It is not recommended to open the capsules in the vicinity of patients with a central venous catheter to prevent unwanted fungal colonization of the catheter, especially transmission through contaminated hands. There have been reports of very rare cases of fungemia (penetration of fungi into the blood) accompanied by fever and positive blood culture results, even in patients not treated with Saccharomyces boulardii. In all cases described, fungemia resolved after antifungal treatment or, when necessary, removal of the central venous catheter.
Enterol contains lactose.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton. Store at temperatures below 25ºC.
Taking other medicines
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Enterol should not be used together with other oral antifungal medicines (medicines used to treat fungal infections).
Pregnancy and breastfeeding
For pregnant or breastfeeding women, consult your doctor before using the medicine.
Due to lack of data, the drug is not recommended for use during pregnancy. Saccharomyces boulardii is not absorbed into breast milk. Due to the lack of data, it is recommended to consider the benefit-risk ratio before using Enterol during breastfeeding.
Use of the drug in children and adolescents
The use of capsules is not recommended in children under 6 years of age due to the possibility of”
