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For the treatment of biliary reflux gastritis: 1 Ursofalk 250 mg capsule daily at bedtime.
For the treatment of primary biliary cirrhosis: During the first 3 months of treatment, the patient should take Ursodeoxycholic acid (Ursofalk) 250 mg capsules in the morning, at midday, and in the evening. As liver function tests improve, the total daily dose may be taken once a day in the evening. (See Table 1).
Click on icon to see table/diagram/imageChildren with cystic fibrosis aged 6 years to less than 18 years: 20 mg/kg/body weight/day in 2-3 divided doses, with a further increase to 30 mg/kg/body weight/day if necessary (see Table 2).
Click on icon to see table/diagram/imageRoute and duration of administration: Swallow the capsules whole, do not chew, with a little fluid.
Take the capsules regularly.
Gallstones generally take from 6 to 24 months to dissolve. If the gallstones have not become smaller after 12 months, do not continue treatment.
The results of therapy should be monitored by ultrasonography or X-ray every 6 months.
For the treatment of biliary reflux gastritis, Ursodeoxycholic acid (Ursofalk) should normally be taken for 10-14 days. The attending physician will decide how long treatment should be continued.
Notes: It is important for the result of treatment to take the capsules regularly.
Liver function parameters should be monitored several times during treatment.
Film-coated tablet: There are no age restrictions on the use of Ursofalk 500 mg film-coated tablets. For patients weighing less than 47 kg or patients who are unable to swallow Ursofalk 500 mg film-coated tablets, Ursofalk capsules are available.
The following daily dose is recommended for the various indications: For dissolution of cholesterol gallstones: Approx 10 mg of ursodeoxycholic acid per kg of body weight, equivalent to: Up to 60 kg: 1 film-coated tablet.
61-80 kg: 1½ film-coated tablets.
81-100 kg: 2 film-coated tablets.
Over 100 kg: 2½ film-coated tablets.
The film-coated tablets should be swallowed whole with some liquid in the evening at bedtime. They must be taken regularly.
The time required for the dissolution of gallstones is generally 6-24 months. If there is no reduction in the size of the gallstones after 12 months, the therapy should not be continued.
The success of the treatment should be checked by means of ultra-sound or X-ray examination 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.
For the 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, Ursofalk 500 mg film-coated tablets should be taken divided over the day. When the liver function parameters improve, the daily dose may be taken once daily in the evening. (See Table 3).
Click on icon to see table/diagram/imageThe film-coated tablets should be swallowed whole with some liquid. They must be taken regularly. The use of Ursofalk 500 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 Ursofalk 500 mg film-coated tablet or one Ursofalk 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 Ursofalk capsule) until the dose indicated in the respective dosage regimen is reached again.
