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Capsule: Please tell the doctor if the patient is taking/using, have recently taken/used or might take/use any other medicines which contain the following active substances. The effects of these medicines may be altered (interactions): A reduction in the effects of the following medicines is possible when taking Ursodeoxycholic acid (Ursofalk) 250 mg capsules: Colestyramine, colestipol (medicines to lower blood lipids) or aluminium hydroxide, smectite (aluminium oxide)-containing antacids (agents that bind gastric acid). If the patient is taking medication that contains any of these active substances, it must be taken at least two hours before or after Ursofalk 250 mg capsules.
Ciprofloxacin, dapsone (antibiotics), nitrendipine (a medicine used to treat high blood pressure) and other medicines which are metabolised in a similar way. The doctor may possibly alter the dose of these medicinal products.
A change in the effects of the following medicines is possible when taking Ursodeoxycholic acid (Ursofalk) 250 mg capsules: Ciclosporin (a medicine that inhibits the immune system). If the patient is being treated with ciclosporin, the doctor should check the amount of ciclosporin in the blood. The doctor will adjust its dose, if necessary.
Rosuvastatin (a medicine for high blood cholesterol).
If the patient is taking Ursodeoxycholic acid (Ursofalk) 250 mg capsules to dissolve gallstones, please tell the doctor if the patient is also taking oestrogen-containing medicinal products or certain medicines to lower the cholesterol levels that contain clofibrate, for example. These medicines may encourage the formation of gallstones and counteract the effects of Ursodeoxycholic acid (Ursofalk) 250 mg capsules in dissolving the gallstones.
Film-coated tablet: Ursofalk 500mg film-coated tablets 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 500mg film-coated tablets.
Ursofalk 500mg 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 500mg film-coated tablets can reduce the absorption of ciprofloxacin.
In a clinical study in healthy volunteers concomitant use of UDCA (500 mg/day) and rosuvastatin (20 mg/day) resulted in slightly elevated plasma levels of rosuvastatin. The clinical relevance of this interaction also with regard to other statins is unknown.
UDCA has been shown to reduce peak plasma concentrations (Cmax) 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 UDCA is recommended. An increase of the dose of nitrendipine may be necessary.
An interaction with a reduction of the therapeutic effect of dapsone was also reported.
These observations, together with in-vitro findings could indicate a potential for UDCA 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 UDCA used for dissolution of gallstones.
