Leaflet URSOBIL 250mg capsules

Indicated for: cholestasis; cholesterol gallstones

Route of administration: oral

Substance: ursodeoxycholic acid (bile acid)

ATC: A05AA02 (Alimentary tract and metabolism | Bile therapy | Bile acids and derivatives)

Ursodeoxycholic acid (ursodiol) is a medication used to treat certain liver and gallbladder conditions. It is a natural bile acid that helps dissolve cholesterol gallstones and protects the liver from damage caused by the accumulation of toxic bile acids. It is commonly used in the treatment of gallstone disease and primary biliary cirrhosis.

Ursodeoxycholic acid works by reducing cholesterol production in the liver and decreasing its absorption in the intestine. It also alters the composition of bile, making it less saturated with cholesterol, which helps dissolve existing gallstones and prevents the formation of new ones.

The medication is taken as tablets or capsules, usually two or three times a day, depending on the condition being treated. It is important for patients to follow their doctor’s instructions and undergo regular check-ups to monitor the progress of the treatment.

Ursodeoxycholic acid is generally well-tolerated, but side effects such as diarrhea, nausea, abdominal pain, or allergic reactions may occur. In rare cases, it may worsen symptoms in patients with advanced liver disease, making careful monitoring essential.

This medication is not suitable for all patients with gallstones, particularly those with calcified stones or a non-functioning gallbladder. It is important for patients to maintain a healthy diet and avoid high-fat foods to support the effectiveness of the treatment.

General data about URSOBIL 250mg

  • Substance: ursodeoxycholic acid
  • Date of latest medicines list: 01-04-2021
  • Product code: W67410001
  • Concentration: 250mg
  • Pharmaceutical form: capsules
  • Quantity: 30
  • Product type: Generic medicine
  • Prescription status: P-6L - Medicines dispensed with a medical prescription that is not retained by the pharmacy and may be renewed; the prescription may be used for 6 months from the date of issue.

Marketing authorisation

  • Manufacturer: ROPHARMA LOGISTIC S.A. - ROMANIA
  • Holder: ROPHARMA S.A. - ROMANIA
  • Number: 13693/2021/01
  • Shelf life: 3 years

Pharmaceutical forms available for ursodeoxycholic acid

Concentrations available for ursodeoxycholic acid

  • 150mg
  • 250mg
  • 250mg/5ml
  • 300mg
  • 500mg