Leaflet URSOBIL 250mg capsules

Product code:
W67410001
Quantity:
30
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