Posology : מינונים

4.2     Posology and method of administration

There are no age restrictions on the use of Ursofalk 500mg tablets. For patients weighing less than 47 kg or patients who are unable to swallow Ursofalk 500mg tablets, Ursofalk 250 mg capsules are available.

For the symptomatic treatment of primary biliary cirrhosis (PBC)

The daily dose depends on body weight and ranges from 1½ to 3½ tablets (14 ± 2 mg of ursodeoxycholic acid per kg of body weight).
For the first 3 months of treatment, Ursofalk 500mg 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.

Body                              Ursofalk 500mg tablets weight (kg)                   first 3 months               subsequently morning         midday       evening       evening
(1 x daily)
47 – 62            ½               ½                ½         1½
63 – 78            ½               ½                1          2
79 – 93            ½               1                1         2½
94 – 109            1               1                1          3
Over 110            1             1              1½             3½ 
The tablets should be swallowed with some liquid. They must be taken regularly.

The use of Ursofalk 500mg 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 500mg tablet or one Ursofalk 250mg capsule daily, and the dose then gradually increased (weekly increase of the daily dose by half a tablet or one Ursofalk 250 mg capsule) until the dose indicated in the respective dosage regimen is reached again.

Special population
Elderly: There is no evidence to suggest that any alteration in the adult dose is needed but the relevant precautions should be taken into account.
Children and adolescents:The indication is very rare in children and adolescents. Therefore there are no adequate data on the efficacy and safety in this population.
The administration of Ursofalk 500mg film-coated tablets is based on body weight and the medical condition.