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BUDENOFALK Gastro-resistant capsule (2018)

Active ingredients: Budesonide

Product Name and Form

Budenofalk 3 mg gastro-resistant capsules.

Pharmaceutical form

Gastro-resistant capsules, hard (gastro-resistant capsules).

Capsule, hard, pink containing white gastro-resistant granules.

Qualitative and Quantitative Composition

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.

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

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)

Pack sizes and Marketing

Al/PVC/PVDC blister strips.

Pack sizes: 10, 50, 90, 100 or 120 capsules.

Not all pack sizes may be marketed.

Marketing authorization holder
Authorization dates

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

04/01/2009

Marketing authorization number:

PL 08637/0002