ProUrsan Forte Special Precautions

Ursodeoxycholic Acid (ProUrsan Forte) should be taken under medical supervision.
Ursodeoxycholic Acid (ProUrsan Forte) is suitable for patients with body weight of 47 kg and over. For patients weighing less than 47 kg or patients who are unable to swallow Ursodeoxycholic Acid (ProUrsan Forte) other formulations are available.
During the first three months of treatment, 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 early detection of potential hepatic deterioration, particularly in patients with advanced stage primary biliary cholangitis.
When used for dissolution of cholesterol gallstones: In order to assess therapeutic progress and for timely detection of any calcification of the gallstones, depending on stone size, the gall bladder should be visualised (oral cholecystography) with overview and occlusion views in standing and supine positions (ultrasound control) 6-10 months after the beginning of treatment.
If the gall bladder cannot be visualised on X-ray images, or in cases of calcified gallstones, impaired contractility of the gall bladder or frequent episodes of biliary colic, Ursodeoxycholic Acid (ProUrsan Forte) should not be used.
Female patients taking Ursodeoxycholic Acid (ProUrsan Forte) for dissolution of gallstones should use an effective non-hormonal method of contraception, since hormonal contraceptives may increase biliary lithiasis (see Interactions and Use in Pregnancy & Lactation).
When used for treatment of advanced stage of primary biliary cholangitis: 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 Ursodeoxycholic Acid (ProUrsan Forte) should be reduced to ½ tablet Ursodeoxycholic Acid (ProUrsan Forte) 500 mg daily and then gradually increased again as described Dosage & Administration.
If diarrhoea occurs, the dose must be reduced and in cases of persistent diarrhoea, the therapy should be discontinued.
Effects on ability to drive and use machines: Ursodeoxycholic acid has no or negligible influence on the ability to drive and use machines.