Registered Rwanda · Rwanda FDA

GYNO BALANCE

Lactose monohydrate BP

Rwanda FDA-HMP-MA-1790 Suppositories 1200 mg INN generic

What it does

Lactose is a sugar found in milk and dairy products. It is often used as an excipient in medications.

Commonly used for: lactose intolerance, as a filler in tablets and capsules

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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.
Rwanda FDA-HMP-MA-1790
Registration date
17/08/2024
Expiry date
16/08/2029
Status
Registered
Active ingredient
Lactose monohydrate BP
Dosage form
Suppositories
Strength
1200 mg
Pack size
2X5 Suppositories
Therapeutic class
-
RxNorm RxCUI
6211
Manufacturer / MAH
Bliss Gvs Pharma
Applicant / LTR
BLISS GVS PHARMA LTD
Country of origin
INDIA
Manufacturer location
102, Hyde Park, Saki Vihar Rd, Ganesh Nagar, Marol, Andheri East, Mumbai, Maharashtra 400072, India

Source: Rwanda Food and Drugs Authority · fetched 2026-03-11 22:07:03 · updated 2026-09-21 02:30:19

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

About this medicine

Lactose is a sugar found in milk and dairy products. It is often used as an excipient in medications.

What it treats

  • lactose intolerance
  • as a filler in tablets and capsules

How it works

Lactose helps improve the texture and stability of medications and is sometimes used as a sweetener.

Who it's for

Individuals who require lactose as part of their medication or those who consume dairy products.

Cautions

  • • May cause digestive issues in people with lactose intolerance.

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

Clinical monograph: lactose

BNF-referenced

Lactose is a disaccharide sugar composed of galactose and glucose, primarily found in milk and dairy products. It serves as a source of energy and is metabolized by the enzyme lactase. In individuals with lactase deficiency, lactose can lead to gastrointestinal symptoms such as bloating, diarrhea, and abdominal pain.

Indications

  • Lactose intolerance
  • As a filler or excipient in pharmaceutical formulations

Dosage

Children: Refer to the BNF for Children for specific dosing information based on age and clinical context.

Adults: Refer to the BNF for specific dosing information based on clinical context.

Mechanism of action

Lactose is metabolized in the intestine by the enzyme lactase into its constituent monosaccharides, glucose and galactose. In individuals with lactase deficiency, unabsorbed lactose passes into the colon, where it is fermented by bacteria, leading to gas production and osmotic effects that contribute to diarrhea.

Pharmacodynamics

The pharmacodynamics of lactose are primarily related to its effects on gastrointestinal function. In healthy individuals, lactose is effectively broken down into glucose and galactose, which are absorbed and utilized for energy. In individuals with lactose intolerance, the unabsorbed lactose can cause osmotic diarrhea and colonic fermentation, leading to discomfort and symptoms associated with lactose intolerance.

Pharmacokinetics

Lactose is not absorbed in the gastrointestinal tract until it is hydrolyzed into glucose and galactose by lactase. The absorption of glucose and galactose occurs in the small intestine. The half-life is not applicable as lactose is not typically administered as a medication but is rather ingested as a natural component of food. Its metabolism primarily occurs in the intestine.

Adverse effects

  • Bloating
  • Diarrhea
  • Abdominal pain
  • Flatulence

Precautions

  • Use with caution in patients with lactose intolerance.
  • Consider potential for gastrointestinal upset in sensitive individuals.

Pregnancy

Lactose is generally considered safe for use during pregnancy. However, consult a healthcare professional for individual advice.

Breast-feeding

Lactose is safe to use while breastfeeding, as it is a natural sugar present in breast milk.

Storage

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

Formulations

  • Powder
  • Granules
  • Tablets
  • Syrup

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

Molecular reference: lactose

PubChem CID 6134

Molecular formula: C12H22O11

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

This drug in other countries

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