Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use

Ursofalk 250 capsules should be taken under medical supervision.
During the first 3 months of treatment, the 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 and non-responders, this monitoring would also enable early detection of potential hepatic deterioration, particularly in patients with advanced stage PBC.

When used for treatment of advanced stage of PBC:
In very rare cases decompensation of hepatic cirrhosis has been observed, which partially regressed after the treatment was 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 250 should be reduced to one Ursofalk 250 capsule daily and then gradually increased again as described in section 4.2.

Treatment of patients with primary sclerosing cholangitis:
Long-term, high-dose (more than recommended) UDCA therapy (28-30 mg/kg/day) in patients with primary sclerosing cholangitis was associated with higher rates of serious adverse events.

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® 250 capsules have no or negligible influence on the ability to drive and use machines.