Hepaurs (UDCA)

Acidum ursodeoxycholicum

One Hepaurs capsule contains ursodeoxycholic acid 150 mg, 250 mg or 300 mg, depending on strength. Excipients with known effect: lactose monohydrate, azorubine (E 122).

Indication: Dissolution of cholesterol gallstones in patients with one or more radiolucent stones (preferably ≤2 cm in diameter) in a functioning gallbladder, who refuse or are not eligible for surgery. Primary biliary cholangitis (primary biliary cirrhosis). In children and adolescents (6-18 years): hepatobiliary disorders associated with cystic fibrosis.

Contraindications (SmPC sec. 4.3): 4.3 Contraindications Hepaurs must not be administered in case of: - hypersensitivity to the active substance or to any of the excipients listed in section 6.1 - acute inflammation of the gallbladder and bile ducts; - obstruction of the bile ducts (common bile duct or gallbladder); - active gastric or duodenal ulcer; - calcified, radiopaque gallstones; - impaired gallbladder contractility; - frequent biliary colic; - inability to visualise the gallbladder radiologically; Children and adolescents - failed hepatoportoenterostomy or biliary atresia without restoration of normal bile flow.

Special warnings and precautions (SmPC sec. 4.4, excerpt): 4.4 Special warnings and precautions for use Hepaurs must be administered under medical supervision. During the first 3 months of treatment, liver function parameters — AST (SGOT), ALT (SGPT) and γGT — should be monitored by the physician every 4 weeks and thereafter every 3 months. In addition to enabling identification of patients who do and do not respond to treatment among those treated for primary biliary cirrhosis, this monitoring may also allow detection of possible deterioration of liver function, particularly in patients with advanced-stage biliary cirrhosis. When administered for dissolution of cholesterol gallstones: To assess therapeutic progress and to allow timely detection of any calcification of gallstones, depending on their size […]