Cholemax Special Precautions

Capsule: Ursodeoxycholic acid has not been associated with the liver damage; however, measure AST and ALT at initiation of and during therapy as indicated by particular clinical circumstances.
Monitoring: perform ultrasound images of gall bladder at 6-month intervals for first year of therapy to monitor gallstone response. If partial stone dissolution is not seen by 12 months of therapy, likelihood of success is greatly reduced.
Oral suspension: UDCA suspension should be taken under medical supervision.
During the first 3 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 PBC, this monitoring would also enable early detection of potential hepatic deterioration, particularly in patients with advance stage PBC.
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 UDCA suspension should be reduced to 250 mg daily and then gradually increased to the recommended dose described in Dosage & Administration.
If diarrhoea occurs, the dose must be reduced and in cases of persistent diarrhoea, the therapy should be discontinued.
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, UDCA suspension should not be used.
Female patients taking UDCA for dissolution of gallstones should use an effective non-hormonal method of contraceptive, since hormonal contraceptives may increase biliary lithiasis (see Interactions and Use in Pregnancy & Lactation).
This medicinal product contains 13 mg sodium per 5 ml of suspension, equivalent to 0.65% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Effects on ability to drive and use machine: UDCA has no or negligible influence on the ability to drive and use machines.