ProUrsan Special Precautions

ProUrsan should be administered under medical supervision.
During the treatment, it is necessary to monitor liver enzyme levels (AST, ALT, γ-GT): during the first 3 months of treatment, they should be monitored every 4 weeks, thereafter every 3 months. Besides determining whether patients treated for primary biliary cirrhosis respond to the treatment or not, this monitoring could allow timely detection of a potential risk of hepatic damage, especially in patients with primary biliary cirrhosis in an advanced stage.
If used for dissolution of cholesterol gallstones: In order to assess therapeutic progress and for timely detection of any calcification of the gallstones, oral cholecystography with radiographs in standing and supine positions or ultrasound control should be performed 6-10 months after the beginning of treatment (depending on stone size).
The product should not be used if the gallbladder cannot be imagined using radiography and in the case of calcification of the gallstones.
Female patients using ProUrsan for dissolution of gallstones should use an efficient non-hormonal contraception method as hormonal anticonception may increase the risk of biliary lithiasis.
If used for the treatment of primary biliary cholangitis in an advanced stage: Decompensation of liver cirrhosis was observed in very rare cases, which partially subsided after discontinuation of the therapy.
In rare cases, clinical symptoms of the disease may worsen in patients with PBC, for example, the pruritus may worsen. In such a case the ProUrsan dose should be reduced to one 250 mg capsule of ProUrsan daily and then the dose should be gradually increased again by one capsule weekly until the originally prescribed dose is reached.
If diarrhoea occurs, the dose must be reduced. If diarrhoea persists, the therapy needs to be stopped.
Effects on ability to drive and use machines: Ursodeoxycholic acid has no or negligible influence on the ability to drive and use machines.
Use in Children: The product is not suitable for children younger than 6 years given the strength of the capsule.