Valid Ghana · FDA Ghana

NORMOFLORA BV CAPSULES

Pre-blend of (Bifidobacterium bifidum , Lactobacillus jenseni , Lactobacillus plantarum , Lactobacillus fermetum , Lactobacillus rhamnosus , Lactobacillus acidophilus , Lactobacillus gasseri , Lactobacillus crispatus , Lactobacillus reuteri ) /Fructo-oligosaccharides

FDA/SD.255-030509 Pre-blend of (Bifidobacterium bifidum , Lactobacillus jenseni , Lactobacillus plantarum , Lactobacillus fermetum , Lactobacillus rhamnosus , Lactobacillus acidophilus , Lactobacillus gasseri , Lactobacillus crispatus , Lactobacillus reuteri ) /Fructo-oligosaccharides 1 billion cfu, 0.5 billion cfu, 1 billion cfu, 1 billion cfu, 1 billion cfu, 1 billion cfu, 0.5 billion cfu, 2 billion cfu, 2 billion cfu) /– 300mg/100mg

What it does

Fructo-oligosaccharides are natural sugars that can help support gut health and digestion.

Commonly used for: digestive health, constipation, irritable bowel syndrome (IBS)

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

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Registration & product details

Registration no.
FDA/SD.255-030509
Registration date
2025-03-25
Expiry date
2030-04-01
Status
Valid
Active ingredient
Pre-blend of (Bifidobacterium bifidum , Lactobacillus jenseni , Lactobacillus plantarum , Lactobacillus fermetum , Lactobacillus rhamnosus , Lactobacillus acidophilus , Lactobacillus gasseri , Lactobacillus crispatus , Lactobacillus reuteri ) /Fructo-oligosaccharides
Dosage form
Pre-blend of (Bifidobacterium bifidum , Lactobacillus jenseni , Lactobacillus plantarum , Lactobacillus fermetum , Lactobacillus rhamnosus , Lactobacillus acidophilus , Lactobacillus gasseri , Lactobacillus crispatus , Lactobacillus reuteri ) /Fructo-oligosaccharides
Strength
1 billion cfu, 0.5 billion cfu, 1 billion cfu, 1 billion cfu, 1 billion cfu, 1 billion cfu, 0.5 billion cfu, 2 billion cfu, 2 billion cfu) /– 300mg/100mg
Pack size
-
Therapeutic class
-
RxNorm RxCUI
259372
Manufacturer / MAH
Applied Communication & Controls
Applicant / LTR
Supra Pharma Limited. P. O Box CT 1578 Cantonments No.9 Nii Bonie Loop, Dzorwulu, Accra, Ghana
Country of origin
-

Source: Food and Drugs Authority · fetched 2026-04-18 08:33:02 · updated 2026-10-20 04:00:08

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

About this medicine

Fructo-oligosaccharides are natural sugars that can help support gut health and digestion.

What it treats

  • digestive health
  • constipation
  • irritable bowel syndrome (IBS)

How it works

They promote the growth of healthy bacteria in the gut, which can improve digestion and overall gut function.

Who it's for

Fructo-oligosaccharides are suitable for adults and children looking to improve their digestive health.

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

Clinical monograph: fructooligosaccharides

Fructooligosaccharides (FOS) are short-chain fructans made up of fructose molecules linked by glycosidic bonds. They are classified as prebiotics, which means they promote the growth of beneficial gut bacteria. FOS are not digested in the upper gastrointestinal tract, allowing them to reach the colon intact where they undergo fermentation by the gut microbiota. This fermentation process produces short-chain fatty acids and gases, which can have various positive health effects.

Indications

  • Constipation
  • Irritable bowel syndrome
  • Gut dysbiosis
  • Enhancing gut health
  • Supporting immune function

Dosage

Children: Refer to specific guidelines or consult a healthcare professional as dosing can vary based on formulation and individual needs.

Adults: Refer to specific guidelines or consult a healthcare professional as dosing can vary based on formulation and individual needs.

Mechanism of action

Fructooligosaccharides exert their effects by selectively stimulating the growth and activity of beneficial gut bacteria, particularly bifidobacteria and lactobacilli. This prebiotic action helps to enhance gut health, improve digestion, and may contribute to immune function. The fermentation of FOS in the colon leads to the production of short-chain fatty acids, which can be utilized by colonocytes for energy and may play a role in maintaining colonic health.

Pharmacodynamics

Fructooligosaccharides demonstrate a significant impact on gut flora composition and overall gut health. They help to increase the population of beneficial bacteria in the intestines, which can improve gut barrier function, reduce inflammation, and enhance nutrient absorption. The production of short-chain fatty acids from FOS fermentation also has systemic effects, potentially influencing metabolic pathways and immune responses.

Pharmacokinetics

Fructooligosaccharides are not absorbed in the upper gastrointestinal tract and have minimal caloric value. They pass through the stomach and small intestine intact and reach the colon, where they are fermented by microbiota. The extent of fermentation can vary among individuals based on their gut microbiota composition. The short-chain fatty acids produced during fermentation are absorbed by colon cells and can enter the systemic circulation, affecting various physiological processes.

Adverse effects

  • Gastrointestinal discomfort
  • Bloating
  • Flatulence
  • Diarrhea
  • Nausea

Precautions

  • Use with caution in patients with irritable bowel syndrome or other gastrointestinal disorders.
  • Monitor for excessive gastrointestinal symptoms when starting treatment.

Pregnancy

Fructooligosaccharides are generally considered safe during pregnancy, but consult a healthcare provider for individual recommendations.

Breast-feeding

Considered safe during breastfeeding, though consultation with a healthcare provider is advised.

Storage

Store in a cool, dry place away from direct sunlight. Keep out of reach of children.

Formulations

  • Powder
  • Granules
  • Tablets
PubChem / pathway

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