Leading the way to safer medication
 Crosscheck  Recommender

BUDENOFALK Rectal foam (2017)

Active ingredients: Budesonide

Product Name and Form

Budenofalk 2mg/dose rectal foam.

Pharmaceutical form

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.

Chemical substance
Description
Budesonide

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.

List of excipients

Cetyl alcohol
Citric acid monohydrate
Disodium edetate
Emulsifying wax
Macrogol stearyl ether
Propylene glycol
Purified water

Propellant:

n-Butane
Isobutane
Propane

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.

Pack sizes:

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.

Marketing authorization holder
Authorization dates

Dr. Falk Pharma GmbH, Leinenweberstr. 5, 79108, Freiburg, Germany

Date of first authorisation: 15 Jun 2006

Date of last renewal: 15 Jun 2011

Marketing authorization number:

PL08637/0011