Composition:
Each hard gelatin capsule contains:
+ Ursodeoxycholic acid 250mg
+ Silymarin (70%) 140mg
+ Excipients: maize starch, colloidal silicon dioxide, magnesium stearate
Capsule shell: titanium dioxide, gelatin
Indications:
(1) For the symptomatic treatment of cholestatic liver diseases e.g. Primary Biliary Cirrhosis (PBC), Non-Alcoholic SteatoHepatitis (NASH) & Chronic Hepatitis. The use of Ursoplus® capsules in primary biliary cirrhosis may be continued indefinitely. In patients with primary biliary cirrhosis, in rare cases the clinical symptoms may worsen at the beginning of treatment, e.g. pruritis may increase. Should this occur, therapy should be continued with a dose of one Ursoplus® capsule daily, and the dosage then gradually increased (by 1 capsule daily each week) until the dose indicated in the respective dosage regimen is reached.
(2) For the symptomatic treatment of toxic metabolic liver diseases.
(3) For the dissolution of radiolucent cholesterol gallstones not larger than 15 mm in diameter in patients with a still functioning gall bladder despite the gall stone(s).
(4) For the treatment of bile reflux gastritis.
Dosage & Administration:
(1) The dose differs according to the type of illness and the response of the patient.
(2) The following daily dose is recommended for the symptomatic treatment of cholestatic liver diseases e.g. primary biliary cirrhosis (PBC), non‐alcoholic steatohepatitis (NASH) & chronic hepatitis:
a. The daily dose of Ursodeoxycholic acid depends on body weight and is approx. 2 to 5 capsules (approx. 10‐15 mg/kg body weight).
b. The following regimen is recommended:
| Body weight |
Daily dose |
Morning |
Midday |
Evening |
| 34to 50 kg |
2capsules |
1 |
- |
1 |
| 51to 70 kg |
3capsules |
1 |
- |
2 |
| 71to 100 kg |
4capsules |
1 |
- |
3 |
| Over 100 kg |
5capsules |
1 |
1 |
3 |
And the above daily dose of Ursodeoxycholic acid is compatible with that of Silymarin, which depends on the patient's condition, ranging from 2 to 3 capsules (approx. 140‐400 mg).