Ursosan 250 mg hard capsules

Basic information

Composition

Each hard capsule contains 250 mg of ursodeoxycholic acid.

Pharmacotherapeutic group

Bile and liver therapy, bile acid preparations (ATC code: A05AA02).

Therapeutic indications

Hepatitis of various aetiologies with cholestatic syndrome, stage 1 and stage 2 primary biliary cirrhosis, primary sclerosing cholangitis. Dissolution of cholesterol gallstones (up to 1.5 cm) in high-risk surgery patients and dissolution of the debris from these stones after lithotripsy – with retained function of the gall bladder. Reactive gastritis with secondary duodenogastric reflux. Liver and biliary tract disease in cystic fibrosis among children aged 6 to 18.

Pharmacological properties

Ursodeoxycholic acid (UDCA) is a bile acid that naturally occurs in human bile. Unlike other bile acids, it is virtually non-toxic.

After oral administration, UDCA inhibits absorption of cholesterol from the intestine, reduces cholesterol synthesis in the liver and reduces secretion of endogenous cholesterol into the bile. The gradual dissolution of small cholesterol gallstones is caused by dispersing the cholesterol and forming liquid crystals with UDCA. In cholestatic liver diseases and reflux gastritis, the beneficial effect of UDCA is due to the changed concentrations of lipophilic bile acids and hydrophilic UDCA, which is caused by the supply of exogenous UDCA and the formation of non-toxic mixed micelles.

UDCA regulates symptomatology and pathological laboratory, immunological and certain histological changes accompanying primary biliary cirrhosis and a number of other liver diseases, particularly if these are connected with intrahepatic cholestasis.

Pharmaceutical form

Hard capsules.

More information

Posology and method of administration

Posology in PBC, PSC and other conditions associated with intrahepatic cholestasis is individual, ranging from 10–15 mg/kg/day, and should not exceed 6 capsules per day divided into 2–3 doses. The daily dose of the medicine used to dissolve gallstones depends on the patient’s body weight. Usually it is 10 mg/kg/day, i.e. 2–5 capsules a day. The entre daily dose of the medicine is administered as a single dose in the evening. The use of UDCA as a medicine to dissolve gallstones is long term (6–24 months). The efficacy of therapy is checked by ultrasound examination once every six months. Reactive gastritis secondary to duodenogastric reflux is treated with 1 capsule daily for 10–14 days. Dosage for children is individual – a dose of 10–20 mg/kg/day is recommended. The length of treatment depends on the character and clinical development of the disease.

Children with cystic fibrosis aged 6 to 18 years: 20 mg/kg/day in 2–3 doses with a subsequent dose increase to a maximum of 30 mg/kg/day.

Capsules are swallowed whole, unchewed and washed down with plenty of liquid.

Contraindications

Hypersensitivity to UDCA and the excipients; acute cholecystitis and cholangitis; obstruction of the bile excretory ducts; calcified bile concretions; impaired gallbladder contractility; frequent biliary colics; children following unsuccessful portoenterostomy or children biliary atresia without recovery of good bile flow; children under 2 years of age.

Interactions

Cholestyramine, colestipol, antacids containing aluminium hydroxide or aluminium oxide lower the absorption and efficacy of UDCA. We recommend taking these medicines 2 hours before or 2 hours after administration of UDCA. Concomitant administration with ciprofloxacin, dapsone or nitrendipine may reduce their effect; use with ciclosporin may affect its absorption. Hypolipidaemics (especially clofibrate) and oestrogens increase cholesterol secretion into bile and may support the formation of gallstones, thus decreasing the chances for successful treatment.

Undesirable effects

Diarrhoea, pain in the right epigastrium, urticaria.

Special warnings and precautions for use

Liver enzymes need to be monitored during therapy: every four weeks during the first three months, later once every quarter. Do not take during pregnancy unless there is a clear need. Administering UDCA during lactation must be considered by a medical specialist.

For more detailed product information, see the Summary of Product Characteristics.

Availability

The medicinal product is available on prescription only. Packing 100 tablets is partly covered by health insurance. Packing 50 tablets is not covered by health insurance in Czech Republic.

Contents of container

10, 50 and 100 hard capsules.

Package available in the Czech Republic

50 and 100 hard capsules

SPC and PIL

Manufacturer and marketing authorisation holder

PRO.MED.CS Praha a.s., Telčská 377/1, Michle, 140 00 Prague 4, Czech Republic

Date of revision of the text

7 January 2020

Product images

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