ABRIDGED PRESCRIBING INFORMATION
Composition: Udihep : Each tablet contains 150mg of Ursodeoxycholic Acid BP. Udihep Forte: Each tablet contains 300mg of Ursodeoxycholic Acid BP.

Indications: Ursodeoxycholic acid is indicated for the treatment of chronic cholestatic liver diseases in particular primary biliary cirrhosis (PBC), for the dissolution of radiolucent, non-calcified gall bladder stones (which are less than 10mm in diameter) in patients with functional gall bladder, for the prevention of gall stone formation, for the relief of symptoms of cholestasis in the management of chronic hepatitis, intrahepatic cholestasis of pregnancy (ICP), alcoholic and non-alcoholic steatohepatitis (NASH) and viral hepatitis.

Dosage and Administration: Adults and children: The recommended dose is 8-15 mg/kg/day which may be given in 2 to 4 divided doses, after meals. Primary Biliary Cirrhosis: The recommended adult dosage is 13-15 mg/kg/day administered in four divided doses with food. Gall Stone Treatment: The recommended dose is 8-15 mg/kg of body weight/day given 2-4 divided doses. Gall Stone Prevention: The recommended dose for cholestasis is 8-15 mg/kg/day in 2-4 divided doses, after meals. Intrahepatic Cholestasis of Pregnancy (ICP): The recommended dose is 12-15 mg/kg/day. Acute Viral Hepatitis: The recommended dose is 600 mg daily for a period of 4 months. Contraindication: Hypersensitivity to bile acids; radio-opaque stones; non-functioning gall bladder.

Precautions: Pregnancy: Category-B. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be appraised of potential risk to the fetus. Lactation: It is not known whether Ursodeoxycholic acid is excreted in human milk. Caution should be exercised when ursodiol is administered to a nursing mother. Side Effects: The following side effects have been reported with the use of UDCA: diarrhea, exacerbation of pre-existing psoriasis, rash, urticaria, dry skin, sweating, hair thinning, leucopenia, stomatitis, flatulence, headache, fatigue, anxiety, depression, sleep disorder, arthralgia, myalgia, back pain, cough and rhinitis. Storage: Store protected from light & moisture at a temperature not exceeding 30°C.

Presentation:

Udihep: Each box contains 3x10s tablets.

Udihep Forte: Each box contains 5x10s tablets.