Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2023 Publisher: Dr. Falk Pharma GmbH, Leinenweberstr. 5, 79108 Freiburg, Germany, Tel.: +49 (0)761 1514-0, Fax: +49 (0)761 1514-321, E-mail: zentrale@drfalkpharma.de, www.drfalkpharma.de
Salofalk 1g gastro-resistant tablets.
| Pharmaceutical Form |
|---|
|
Gastro-resistant tablets. Yellow to ochre yellow, oblong, biconvex, rounded edges gastro-resistant tablets with smooth surface. |
Each gastro-resistant tablet contains 1g mesalazine.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Mesalazine |
Mesalazine is an aminosalicylate. The mechanism of action of mesalazine is not fully understood, but appears to have a topical anti-inflammatory effect on the colonic epithelial cells. Mucosal production of arachidonic acid metabolites, both through the cyclooxygenase and lipoxygenase pathways, is increased in patients with chronic inflammatory bowel disease, and it is possible that mesalazine diminishes inflammation by blocking cyclooxygenase and inhibiting prostaglandin production in the colon. |
| List of Excipients |
|---|
|
Cellulose, microcrystalline |
Blister: PVC/PVDC (orange-transparent)/aluminium blister foil
Package sizes: Blister packs with 20, 50, 60, 90,100 and 150 Salofalk 1g tablets.
Not all pack sizes may be marketed.
Dr. Falk Pharma GmbH, Leinenweberstr. 5, 79108 Freiburg, Germany, Tel.: +49 (0)761 1514-0, Fax: +49 (0)761 1514-321, E-mail: zentrale@drfalkpharma.de, www.drfalkpharma.de
PL08637/0027
Date of first authorisation: 10th May 2017
| Drug | Countries | |
|---|---|---|
| SALOFALK | Austria, Australia, Canada, Cyprus, Germany, Ecuador, Estonia, Spain, Finland, Hong Kong, Croatia, Ireland, Lithuania, Malta, Mexico, Netherlands, Poland, Romania, Singapore, Turkey, United Kingdom, South Africa |
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