Untitled Document
Administration: Should be taken with food.
Contraindications: Acute inflammation of gallbladder or biliary tract, biliary tract occlusion (common bile duct or cystic duct), frequent episodes of biliary colic, radio-opaque calcified gallstones, impaired contractility of gallbladder, gallstone pancreatitis or biliary-gastrointestinal fistula, non-functioning gallbladder, inflammatory bowel disease; hepatic and intestinal conditions interfering with enterohepatic recirculation of bile acids (e.g. extrahepatic and intrahepatic cholestasis, ileal resection and stoma, regional ileitis); active duodenal and gastric ulcer; unsuccessful portoenterostomy or without recovery of normal bile flow in children with biliary atresia. Acute, chronic or severe hepatic impairment.
Special Precautions: Patients with non-visualising gallbladder, variceal bleeding, hepatic encephalopathy, ascites. Obese patients. Children. Pregnancy and lactation.
Adverse Reactions:
- • Significant: Biliary obstruction.
- • Gastrointestinal disorders: Diarrhoea, pasty stools, nausea, vomiting, constipation, dyspepsia; rarely, severe right upper abdominal pain (if used for primary biliary cirrhosis).
- • Hepatobiliary disorders: Rarely, calcification of gallstones, decompensation of liver cirrhosis.
- • Musculoskeletal and connective tissue disorders: Back pain.
- • Nervous system disorders: Headache, dizziness.
- • Respiratory, thoracic and mediastinal disorders: Upper respiratory tract infection.
- • Skin and subcutaneous tissue disorders: Urticaria, pruritus. *