Active ingredients: Budesonide
Budenofalk 2mg/dose rectal foam.
Rectal foam, pressurised container.
White to pale white, creamy firm foam.
Each dose of 1.2 g foam contains 2 mg of budesonide.
Excipients with known effect: cetyl alcohol, propylene glycol.
For the full list of excipients, see section 6.1.
Budesonide is a glucocorticosteroid with a high local anti-inflammatory effect. At doses clinically equivalent to systemically acting glucocorticosteroids, budesonide gives significantly less HPA axis suppression and has a lower impact on inflammatory markers.
Citric acid monohydrate
Macrogol stearyl ether
Aluminium pressurised container with metering valve together with 14 PVC applicators coated with white soft paraffin and liquid paraffin for administration of the foam and 14 plastic bags for hygienic disposal of the applicators.
Original pack with 1 pressurised container, contains at least 14 doses of 1.2 g rectal foam each.
Original pack with 2 pressurised containers, contains at least 2 × 14 doses of 1.2 g rectal foam each.
Hospital pack with 1 pressurised container, contains at least 14 doses of 1.2 g rectal foam each.
Not all pack sizes may be marketed.
Dr. Falk Pharma GmbH, Leinenweberstr. 5, 79108, Freiburg, Germany
Date of first authorisation: 15 Jun 2006
Date of last renewal: 15 Jun 2011