URSOSAN FORTE FILM-COATED TABLETS 500MG

INDICATION

• Dissolution of cholesterol gallstones in the gallbladder. The gallstones must not show as shadows on X-ray images and should not exceed 15 mm in diameter. Gall bladder must be functioning, despite the gallstones.
• Symptomatic treatment of primary biliary cirrhosis (PBC), in patients without decompensated hepatic cirrhosis.

CONTRAINDICATIONS

• Hypersensitivity to the active substance or to any of the excipients;
• Acute inflammation of the gallbladder or biliary tract;
• Occlusion of the biliary tract (occlusion of the common bile duct or cystic duct);
• Frequent episodes of biliary colics;
• Radio-opaque calcified gallstones;
• Impaired contractility of the gallbladder.

RECOMMENDED DOSAGE

Posology

For patients weighing less than 47 kg or patients who are unable to swallow Ursosan Forte® 500mg filmcoated tablets, ursodeoxycholic acid capsules are available.

Dissolution of cholesterol gallstones

The recommended dose in adult patients dependent on the body weight (10 mg/kg/day).

The total daily dose should be administered as one single dose, in the evening at bedtime. Ursosan Forte® needs to be taken regularly.

The time required for dissolution of gallstones is generally 6 to 24 months, depending on stone size and composition. If there is no reduction in the size of the gallstones after 12 months, the therapy should not be continued. The success of treatment should be checked sonographically or radiographically every 6 months. At the follow-up examinations, a check should be made to see whether calcification of the stones has occurred in the meantime. Should this be the case, the treatment must be ended.

Symptomatic treatment of primary biliary cirrhosis (PBC)

The daily dose depends on body weight and ranges from 1½ to 3½ film-coated tablets (14 ± 2 mg of ursodeoxycholic acid per kg of body weight).

For the first 3 months of treatment, Ursosan Forte® should be taken divided over the day. When the liver function parameters improve, the daily dose may be taken once daily in the evening.

The use of Ursosan Forte® mg film-coated tablets in primary biliary cirrhosis may be continued indefinitely. In patients with primary biliary cirrhosis, in rare cases the clinical symptoms may worsen at the beginning of treatment, e.g. the itching may increase. In this event, therapy should first be continued with half an Ursosan Forte® film-coated tablets or one ursodeoxycholic acid capsule (containing 250 mg of ursodeoxycholic acid) daily, and the dose then gradually increased (weekly increase of the daily dose by half a film-coated tablet or one ursodeoxycholic acid capsule) until the dose indicated in the respective dosage regimen is reached again. In this case the dose of Ursosan Forte® should be reduced to one Ursosan 250 mg capsule daily and then gradually increased again until the dose indicated in the respective dosage regimen is reached again.

Method of administration

The tablets should be swallowed whole and not chewed, with a sufficient amount of fluids. The tablets must be taken regularly.