Special Warning : אזהרת שימוש

4.4    Special warnings and precautions for use
Ursofalk 500mg tablets should be taken under medical supervision.

During the first 3 months of treatment, liver function parameters AST (SGOT), ALT (SGPT) and -GT should be monitored by the physician every 4 weeks, thereafter every 3 months. Apart from allowing for identification of responders or non-responders in patients being treated for primary biliary cirrhosis, this monitoring would also enable early detection of potential hepatic deterioration, particularly in patients with advanced stage primary biliary cirrhosis.

When used for treatment of the advanced stages of primary biliary cirrhosis: In very rare cases decompensation of the hepatic cirrhosis has been observed; which partially regressed after the treatment discontinued.

In patients with PBC, in rare cases the clinical symptoms may worsen at the beginning of treatment, e.g. the itching may increase. In this case the dose of Ursofalk 500mg tablets should be reduced to half a tablet Ursofalk 500mg tablets or one Ursofalk 250mg capsule daily and then gradually increased again as described in section 4.2.


If diarrhoea occurs, the dose must be reduced and in cases of persistent diarrhoea, the therapy should be discontinued

Effects on Driving

4.7    Effects on ability to drive and use machines

Ursofalk 500mg tablets have no or negligible influence on the ability to drive and use machines.