BUDENOFALK Rectal foam (2017)
Active ingredients: Budesonide
Product Name and Form
Budenofalk 2mg/dose rectal foam.
Rectal foam, pressurised container.
White to pale white, creamy firm foam.
Qualitative and Quantitative Composition
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.
Citric acid monohydrate
Macrogol stearyl ether
Pack sizes and Marketing
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