URSOBIL 250 mg capsules, hard
Composition
1 capsule contains 250 mg ursodeoxycholic acid.
What URSOBIL® 250 mg capsule is and what it is used for
URSOBIL® 250 mg capsules contain the active substance ursodeoxycholic acid which is a naturally occurring bile acid which is found in small amounts in human bile.
URSOBIL® 250 mg capsules are used to dissolve small gallstones and for the treatment of a liver disease (primary biliary cirrhosis) by e.g. stimulating bile flow.
In children and adolescents aged 6 to 18 years this medicines is used to treat liver-bile disorders associated with cystic fibrosis.
INDICATIONS
URSOBIL® 250 mg capsules are used to dissolve small gallstones and for the treatment of a liver disease (primary biliary cirrhosis) by e.g. stimulating bile flow.
In children and adolescents aged 6 to 18 years this medicines is used to treat liver-bile disorders associated with cystic fibrosis.
How to take URSOBIL® 250 mg capsules
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The capsules should be swallowed whole with sufficient liquid.
Dissolution of gallstones
The recommended dose in adults is: 10-12 mg/kg body weight daily, divided in 2 doses during the day.
It generally takes 6-24 months to dissolve gallstones. If there are no reduction in the size of the gallstones after 12 months, treatment should be stopped.
6 to 10 months after the beginning of treatment, your doctor will test if the treatment issuccessful.
Primary biliary cirrhosis
The recommended dose in adults is: 12-16 mg/kg body weight daily.
During the first 3 months of treatment, URSOBIL® 250 mg capsules should be taken in divided doses during the day. As liver function tests improve, the total daily dose may be taken once a day, preferably in the evening.
URSOBIL® 250 mg capsules can be continued indefinitely in cases of primary biliary cirrhosis.
In patients with primary biliary cirrhosis, the clinical symptoms may worsen at the start of treatment, for example the itching may increase. This only occurs in rare cases. In this case, therapy can be continued with a lower daily dose of URSOBIL® 250 mg capsules. Each week, your doctor will then gradually increase the daily dose, until you reach the required dose.
Use in children and adolescents
Children with cystic fibrosis aged 6 years to 18 years:
The recommended dose is 20 mg/kg/day divided into 2-3 doses, with a further increase to 30 mg/kg/day if necessary.
What URSOBIL® 250 mg capsules look like and contents of the pack
White capsules.
Blister (PVC/Alu): 50 capsules
Manner of prescription
Prescription only medicine.