Registered Rwanda · Rwanda FDA

NORMAGUT CAPSULES

Saccharomyces boulardii

Rwanda FDA-HMP-MA-2133 CAPSULES 250MG

What it does

Boulardii is a type of beneficial yeast that helps maintain gut health.

Commonly used for: diarrhea, gastrointestinal infections, irritable bowel syndrome (IBS)

Read more in plain English ↓

Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
Rwanda FDA-HMP-MA-2133
Registration date
18/10/2024
Expiry date
17/10/2029
Status
Registered
Active ingredient
Saccharomyces boulardii
Dosage form
CAPSULES
Strength
250MG
Pack size
1x10\'s
Therapeutic class
-
Manufacturer / MAH
Ardeypharm
Country of origin
GERMANY
Manufacturer location
Loerfeldstraße 20, 58313 Herdecke, Germany

Source: Rwanda Food and Drugs Authority · fetched 2026-03-11 22:07:03 · updated 2026-09-17 02:30:43

Disclaimer: This information is sourced from Rwanda Food and Drugs Authority (Rwanda). Always consult a qualified healthcare professional before using any medication.

About boulardii

Boulardii is a type of beneficial yeast that helps maintain gut health.

What it treats

  • diarrhea
  • gastrointestinal infections
  • irritable bowel syndrome (IBS)

How it works

Boulardii supports healthy digestion by promoting the growth of good bacteria in the gut.

Who it's for

It is suitable for people experiencing digestive issues or looking to maintain gut health.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About saccharomyces

Saccharomyces is a type of yeast used as a dietary supplement to support digestive health.

What it treats

  • digestive issues
  • diarrhea
  • irritable bowel syndrome (IBS)
  • promoting gut health

How it works

Saccharomyces helps balance good bacteria in the gut, which can improve digestion and overall gut health.

Who it's for

Adults and children experiencing digestive problems or those looking to support their gut health.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: boulardii

Saccharomyces boulardii is a probiotic yeast used to support gastrointestinal health. It is known for its ability to restore the natural flora of the gut, particularly following disturbances such as antibiotic therapy or episodes of diarrhoea. Boulardii can help in the prevention and treatment of various forms of diarrhoea, including antibiotic-associated diarrhoea and acute infectious diarrhoea. It may also play a role in managing conditions like irritable bowel syndrome and inflammatory bowel diseases.

Indications

  • Antibiotic-associated diarrhoea
  • Acute infectious diarrhoea
  • Clostridium difficile infection
  • Irritable bowel syndrome
  • Inflammatory bowel disease

Dosage

Children: Refer to the specific product guidelines for dosing, as it may vary based on formulation and indication.

Adults: Refer to the specific product guidelines for dosing, as it may vary based on formulation and indication.

Mechanism of action

Saccharomyces boulardii exerts its beneficial effects by several mechanisms. It helps to restore the intestinal microbiota balance, enhances the intestinal barrier function, and modulates immune responses. It produces short-chain fatty acids and other metabolites that can inhibit pathogen adherence and growth. Boulardii also stimulates the production of mucin, which is important for maintaining the integrity of the gut lining.

Pharmacodynamics

The pharmacodynamic properties of Saccharomyces boulardii are primarily related to its ability to interact with the gut microbiota and immune system. It exhibits antimicrobial activity against various pathogens, including Clostridium difficile and Escherichia coli, and can modulate inflammatory responses in the gut. Boulardii is also known to enhance the absorption of nutrients and improve gut motility.

Pharmacokinetics

Saccharomyces boulardii is not absorbed systemically; rather, it acts locally within the gastrointestinal tract. After oral administration, it survives the gastric environment and colonizes the intestines transiently, exerting its effects. The viability of boulardii is critical for its action, and it is typically taken as a live yeast culture. The duration of action is influenced by the intestinal transit time and the presence of competing microorganisms.

Adverse effects

  • Gas
  • Bloating
  • Abdominal discomfort
  • Diarrhea

Precautions

  • Use with caution in immunocompromised patients
  • Consider potential for fungal infections in at-risk populations

Pregnancy

No adequate studies in pregnant women are available, consult healthcare provider before use.

Breast-feeding

Generally considered safe, but consult healthcare provider for individual assessment.

Storage

Store in a cool, dry place. Keep out of reach of children.

Formulations

  • Capsules
  • Powder for reconstitution
  • Tablets

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Clinical monograph: saccharomyces

Saccharomyces, commonly known as brewer's or baker's yeast, is a genus of fungi used for its fermentative properties. It is primarily utilized in the production of alcoholic beverages, baking, and as a dietary supplement due to its probiotic effects. Saccharomyces boulardii, a specific strain, is recognized for its beneficial effects on gastrointestinal health.

Indications

  • Antibiotic-associated diarrhea
  • Acute infectious diarrhea
  • Chronic diarrhea in conditions like irritable bowel syndrome
  • Maintenance of gut flora during antibiotic therapy
  • Prevention of traveler's diarrhea

Dosage

Children: Refer to specific product guidelines for paediatric dosages, as they may vary depending on the formulation and age of the child.

Adults: Refer to specific product guidelines for recommended adult dosages, as they may vary depending on the formulation.

Mechanism of action

Saccharomyces boulardii exerts its effects by promoting gut health through various mechanisms. It enhances the intestinal barrier function, modulates local immune responses, and inhibits the growth of pathogenic bacteria. It also produces short-chain fatty acids and aids in the maintenance of gut microbiota balance, which can help in reducing diarrhea and improving gut health.

Pharmacodynamics

The pharmacodynamics of Saccharomyces involve its ability to adhere to intestinal mucosa, which helps in restoring the normal flora of the gut. It has been shown to reduce the duration and severity of diarrhea, particularly in cases of antibiotic-associated diarrhea and infectious diarrhea. Additionally, it may enhance the absorption of nutrients and support the immune system.

Pharmacokinetics

Saccharomyces boulardii is generally not absorbed systemically; instead, it acts locally in the gastrointestinal tract. It survives passage through the stomach and colonizes the intestines, where it exerts its beneficial effects. The viability of Saccharomyces is influenced by factors such as pH, temperature, and the presence of other gastrointestinal microorganisms. Its effects are typically observed within a few days of administration.

Adverse effects

  • Gastrointestinal upset
  • Bloating
  • Gas
  • Diarrhea

Interactions

  • May interact with antifungal medications
  • Potential interactions with immunosuppressive drugs

Precautions

  • Caution in patients with compromised immune systems
  • Use with caution in patients with a history of yeast allergies

Pregnancy

Limited data available, consult healthcare provider before use.

Breast-feeding

Generally considered safe, but consult healthcare provider.

Storage

Store in a cool, dry place, away from direct sunlight.

Formulations

  • Capsules
  • Tablets
  • Powder for oral suspension
  • Granules

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.