Active ingredients: Budesonide
Budenofalk 3 mg gastro-resistant capsules.
Gastro-resistant capsules, hard (gastro-resistant capsules).
Capsule, hard, pink containing white gastro-resistant granules.
Each capsule contains 3 mg budesonide.
Excipients with known effect: each capsule contains 240 mg sucrose and 12 mg lactose monohydrate.
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.
Capsule contents:
Ammonio methacrylate copolymer (type A) (Eudragit RL)
Ammonio methacrylate copolymer (type B) (Eudragit RS)
Lactose monohydrate
Maize starch
Methacrylic acid-methyl methacrylate copolymer (1:1) (Eudragit L 100)
Methacrylic acid-methyl methacrylate copolymer (1:2) (Eudragit S 100)
Povidone K25
Purified water*
Sucrose
Talc
Triethyl citrate
* intermediate excipient
Capsule shell:
Black iron oxide (E172)
Erythrosine (E127)
Gelatin
Purified water
Red iron oxide (E172)
Sodium laurilsulphate
Titanium dioxide (E171)
Al/PVC/PVDC blister strips.
Pack sizes: 10, 50, 90, 100 or 120 capsules.
Not all pack sizes may be marketed.
Dr. Falk Pharma GmbH, Leinenweberstr. 5, 79108, Freiburg, Germany
PL 08637/0002
04/01/2009