(2) Gall stones: In Cholesterol Gall Stones (75% Cholesterol)

(3) Bile Reflux Gastritis: A condition in which bile refluxes into the stomach due to incompetent sphincters leading to ulceration in gastric mucosa.

(4) Non Alcoholic Steato-Hepatitis (NASH): To denote chronic liver disease associated with steatosis and inflammatory response with an increase in liver enzymatic activity, in absence of considerable alcohol consumption, viral or autoimmune hepatitis.

(5) Intrahepatic Cholestasis in Pregnancy: Cholestasis of pregnancy associated with high fetal risk.It was difficult or nearly impossible to treat it in the past. It results in bile acids crossing the placenta.

(6) Supportive therapy in Acute & Chronic Hepatitis.

COMBINATION:

Each hard gelatin capsule contains:

• Ursodeoxycholic acid 250mg.
• Excipients: maize starch, silica colloidal anhydrous, magnesiumstearate.
• Capsule shell: gelatin, titanium dioxide, water purified, sodiumlauryl sulphate.

INDICATIONS:

• For the dissolution of radiolucent cholesterol gallstones not2larger than 15 mm in diameter in patients with a stillfunctioning gall bladder despite the gall stone(s).
• For the treatment of bile reflux gastritis.
• For the symptomatic treatment of cholestatic liver diseases e.g.Primary Biliary Cirrhosis (PBC), Non-Alcoholic SteatoHepatitis(NASH) & Chronic Hepatitis.The use of Ursofalk® capsules in primary biliary cirrhosismay be continued indefinitely. In patients with primary biliary cirrhosis, in rare cases theclinical symptoms may worsen at the beginning oftreatment, e.g. pruritis may increase. Should this occur,therapy should be continued with a dose of one Ursofalk®capsule daily, and the dosage then gradually increased(by 1 capsule daily each week) until the dose indicated inthe respective dosage regimen is reached.
• For the symptomatic treatment of toxic metabolic liver diseases.

DOSAGE AND ADMINISTRATION:

The following daily dose is recommended for various indications:§

• For dissolution of cholesterol gall stones:
  • Approx. 10 mg/kg bodyweight daily, equivalent to:

• • The capsules should be swallowed as whole with some liquid in theevening at bedtime.
  • The capsules must be taken regularly.
  • The time required for dissolution of gallstones is generally 6-24months. If there is no reduction in the size of the gall stones after 12months, the therapy should not be continued.
  • The success of treatment should be checked by ultrasoundinvestigation or cholecystograms every 6 months. At the follow-up examinations, a check should be made to see whether calcification ofthe stones has occurred in the meantime. Should this be the case, sotreatment must be ended.
• For the treatment of bile reflux gastritis:
  • One capsule daily swallowed whole with some liquid in the eveningat bedtime.
  • Ursofalk® capsules should generally be taken for 10-14 days. Theduration of use depends on the course of the condition. The durationof use is decided on an individual basis by the doctor responsible forthe treatment.·
• For the symptomatic treatment of cholestatic liver diseases e.g. PrimaryBiliary Cirrhosis (PBC), Non-Alcoholic SteatoHepatitis (NASH) & Chronic Hepatitis:
  • The daily dose depends on body weight and is approx. 2 to 6capsules (approx. 10-15 mg/kg body weight).
  • The following regimen is recommended: