Take orally with food. For gallstone dissolution, a single dose at bedtime is often recommended. For PBC, doses are usually divided and taken with meals. Swallow tablets whole with water; do not chew.

Ursodeoxycholic acid suppresses hepatic synthesis and secretion of cholesterol, thereby lowering its saturation in bile. It also changes the composition of bile from lithogenic to non-lithogenic, facilitating the dissolution of cholesterol gallstones. In cholestatic liver diseases, it replaces toxic bile acids, protects liver cells from damage, and improves bile flow.

• •Hypersensitivity to ursodeoxycholic acid or any component of the formulation
• •Acute inflammation of the gallbladder or bile ducts
• •Occlusion of the bile duct (e.g., common bile duct obstruction)
• •Frequent episodes of biliary colic
• •Calcified cholesterol gallstones, radio-opaque gallstones
• •Non-functioning gallbladder

Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.

Overdose may cause diarrhea. In general, other symptoms of overdose are unlikely as the absorption of UDCA decreases with increasing dose. Treatment is symptomatic, and no specific antidote is known. Discontinuation of the drug is usually sufficient.

Pregnancy Category B. Studies in animals have not shown harm, but human data are limited. Use only if clearly needed and the potential benefits outweigh the risks. Excreted in breast milk in small amounts, generally considered safe but caution is advised; consult a doctor.