Registered Rwanda · Rwanda FDA

UDIHEP FORTE

Ursodeoxychobic acid 300mg

Rwanda FDA-HMP-MA- 0863 Uncoated tablets 300mg

What it does

Ursodeoxycholic acid helps improve liver function and reduce bile acid buildup.

Commonly used for: liver disease (cholestasis), gallstones, primary biliary cholangitis

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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- 0863
Registration date
22/02/2024
Expiry date
21/02/2029
Status
Registered
Active ingredient
Ursodeoxychobic acid 300mg
Dosage form
Uncoated tablets
Strength
300mg
Pack size
5x10 Tablets
Therapeutic class
-
Manufacturer / MAH
Win-medicare
Applicant / LTR
WIN-MEDICARE PVT. LTD
Country of origin
INDIA
Manufacturer location
158/177, National High School Road, Vishweshwarapura, Basavanagudi, Bengaluru, Karnataka 560004, India

Source: Rwanda Food and Drugs Authority · fetched 2026-03-11 22:07:20 · updated 2026-09-21 02:30:20

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

Ursodeoxycholic acid helps improve liver function and reduce bile acid buildup.

What it treats

  • liver disease (cholestasis)
  • gallstones
  • primary biliary cholangitis

How it works

It works by helping to dissolve bile acids and improve the flow of bile from the liver.

Who it's for

This medication is for adults with certain liver and gallbladder conditions.

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

Clinical monograph: ursodeoxychobic

Ursodeoxycholic acid, also known as ursodiol, is a bile acid used primarily in the treatment of certain liver and gallbladder disorders. It is derived from bear bile and is used to dissolve cholesterol gallstones and to treat primary biliary cholangitis, an autoimmune disease that damages the bile ducts in the liver.

Indications

  • Dissolution of cholesterol gallstones in patients with symptomatic gallstones
  • Primary biliary cholangitis
  • Liver disease associated with cystic fibrosis
  • Cholestatic liver diseases

Dosage

Children: Refer to the BNF for Children for appropriate dosing based on the child's condition and weight.

Adults: Refer to specific guidelines for dosing based on the condition being treated. Generally, dosing may range from 8-12 mg/kg/day for gallstone dissolution.

Mechanism of action

Ursodeoxycholic acid works by reducing the cholesterol content of bile, which promotes the dissolution of cholesterol gallstones. It also enhances bile flow and has cytoprotective effects on hepatocytes, thereby improving liver function. Additionally, it may inhibit apoptosis and promote the regeneration of liver cells through its action on various cellular pathways.

Pharmacodynamics

Ursodeoxycholic acid has several pharmacodynamic effects including the reduction of cholesterol saturation in bile, increased bile acid flow, and modulation of immune responses. It exerts a protective effect on cholangiocytes and hepatocytes, reduces the toxicity of hydrophobic bile acids, and has anti-inflammatory properties.

Pharmacokinetics

Ursodeoxycholic acid is absorbed in the small intestine and undergoes enterohepatic recirculation. It is metabolized primarily in the liver, with a small portion excreted in the urine. The bioavailability of ursodeoxycholic acid is approximately 60% after oral administration, with peak plasma concentrations occurring 1-3 hours post-dose. The half-life is approximately 3-5 hours.

Contra-indications

  • Hypersensitivity to ursodeoxycholic acid or any of the excipients
  • Severe liver impairment
  • Pregnancy (unless clearly needed)

Adverse effects

  • Diarrhea
  • Constipation
  • Nausea
  • Vomiting
  • Abdominal pain
  • Headache
  • Pruritus

Interactions

  • Antacids containing aluminum can decrease the absorption of ursodeoxycholic acid
  • Cholestyramine and other bile acid sequestrants may reduce the effects of ursodeoxycholic acid
  • Estrogens may increase the risk of gallstone formation when used with ursodeoxycholic acid

Precautions

  • Monitor liver function tests regularly during treatment
  • Use with caution in patients with active liver disease
  • Evaluate the risks versus benefits in patients with gallstones

Pregnancy

Ursodeoxycholic acid should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus.

Breast-feeding

Ursodeoxycholic acid is excreted in breast milk; caution should be exercised when administered to nursing mothers.

Storage

Store at room temperature, away from moisture and heat. Keep out of reach of children.

Formulations

  • Capsule
  • Tablet
  • Oral suspension

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