Special Warning : אזהרת שימוש

4.4 Special warnings and precautions for use:

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

When used for the dissolution of cholesterol gallstones:

In order to be able to assess the therapeutic progression of the dissolution of gallstones and to timely identify a possible calcification of the stones, depending on stone size, the gall bladder should be visualised 6 to 10 months after the start of the treatment (oral cholecystography) with total image and occlusions and in the standing and lying position (ultrasound investigation).

If the gall bladder cannot be visualised on X-rays, or in cases of calcified gallstones, impaired contractility of the gall bladder or frequent episodes of biliary colic, the treatment with Ursolit should be discontinued.

When used for treatment of advanced stage of primary biliary cirrhosis: 
In very rare cases decompensation of hepatic cirrhosis is observed, which partially decreased after the treatment was discontinued.

In patients with PBC, the clinical symptoms may worsen in rare cases at the start of treatment, e.g. pruritus may increase. In this case, the therapy is to be continued with a dose reduction and subsequently should be gradually increased to the recommended dose as described in section 4.2.

If diarrhea occurs, the dose should be reduced and in cases of persistent diarrhea, the therapy should be discontinued.
When used for treatment of patients with primary sclerosing cholangitis: Long-term, high-dose (more than recommended) ursodeoxycholic acid therapy (28- 30 mg/kg/day) in patients with primary sclerosing cholangitis was associated with higher rates of serious adverse events.

Female patients who use Ursodeoxycholic acid for dissolving gall stones must use an effective non-hormonal method of contraception, since hormonal contraception may increase biliary lithiasis (see sections 4.5 and 4.6)

Excipient(s)
Lactose
Patients with rare hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption should not take this medicine.

Effects on Driving

4.7 Effects on ability to drive and use machines
Ursodeoxycholic acid has no or negligible influence on the ability to drive and use machines.