Ursofalk Drug Interactions

Ursofalk should not be administered concomitantly with colestyramine, colestipol or antacids containing aluminium hydroxide and/or smectite (aluminium oxide), because these preparations bind ursodeoxycholic acid in the intestine and thereby inhibit its absorption and efficacy. Should the use of a preparation containing one of these substances be necessary, it must be taken at least 2 hours before or after Ursofalk 250mg capsules/500 mg film-coated tablets.
Ursofalk 250mg capsules/500 mg film-coated tablets can affect the absorption of ciclosporin from the intestine. In patients receiving ciclosporin treatment, blood concentrations of this substance should therefore be checked by the physician and the ciclosporin dose adjusted if necessary.
In isolated cases, Ursofalk 250mg capsules/500 mg film-coated tablets can reduce the absorption of ciprofloxacin.
Ursodeoxycholic acid has been shown to reduce plasma peak concentrations (C_max) and area under the curve (AUC) of the calcium antagonist nitrendipine in healthy volunteers.
Close monitoring of the outcome of concurrent use of nitrendipine and ursodeoxycholic acid is recommended. An increase of the dose of nitrendipine may be necessary. An interaction with a reduction of the therapeutic effects of dapsone was also reported.
These observations, together with in-vitro findings could indicate a potential for ursodeoxycholic acid to induce cytochrome P450 3A enzymes. Induction has, however, not been observed in a well-designed interaction study with budesonide which is a known cytochrome P450 3A substrate.
Oestrogenic hormones and blood cholesterol lowering agents such as clofibrate increase hepatic cholesterol secretion and may therefore encourage biliary lithiasis, which is a counter-effect to ursodeoxycholic acid used for dissolution of gallstones.
In a clinical study in healthy volunteers concomitant use of ursodeoxycholic acid (500mg/day) and rosuvastatin (20mg/day) resulted in slightly elevated plasma levels of rosuvastatin. The clinical relevance of this interaction also with regard to other statins is unknown.
FC tablet: Female patients taking Ursofalk for dissolution of gallstones should use an effective non‐hormonal method of contraception, since hormonal contraceptives may increase biliary lithiasis.
Controlled clinical studies have shown, however, that ursodeoxycholic acid does not have a relevant inductive effect on cytochrome P450 3A enzymes.