Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Dr. Falk Pharma GmbH, Leinenweberstr. 5, 79108, Freiburg, Germany
Budenofalk 3 mg gastro-resistant capsules.
| Pharmaceutical Form |
|---|
|
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.
| Active Ingredient |
|---|
|
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) * intermediate excipient Capsule shell: Black iron oxide (E172) |
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
| Drug | Countries | |
|---|---|---|
| BUDENOFALK | Australia, Cyprus, Estonia, Finland, Hong Kong, Ireland, Lithuania, Netherlands, Poland, Romania, Singapore, Turkey, United Kingdom |
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