Source: Health Products Regulatory Authority (IE) Revision Year: 2022 Publisher: J. Uriach y Compania S.A., Av. Cami Reial 51-57, 08184 Palau-solita i Plegamans, Barcelona, Spain
Rupafin 10 mg tablets.
| Pharmaceutical Form |
|---|
|
Tablet. Round, light salmon coloured tablets. |
Each tablet contains: 10 mg of rupatadine (as fumarate).
Excipient with known effect: lactose 57.57 mg as lactose monohydrate.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Rupatadine |
Rupatadine is a second-generation antihistamine, long-acting histamine antagonist, with selective peripheral H1-receptor antagonist activity. Some of the metabolites (desloratadine and its hydroxylated metabolites) retain an antihistaminic activity and may partially contribute to the overall efficacy of the drug. |
| List of Excipients |
|---|
|
Pregelatinised maize-starch |
PVC/PVDC/aluminium blister.
Packs of 3, 7, 10, 15, 20, 30, 50 and 100 tablets. Not all pack sizes may be marketed.
J. Uriach y Compania S.A., Av. Cami Reial 51-57, 08184 Palau-solita i Plegamans, Barcelona, Spain
PA1129/001/001
Date of first authorisation: 09 January 2004
Date of last renewal: 19 July 2016
| Drug | Countries | |
|---|---|---|
| RUPAFIN | Austria, Brazil, Cyprus, Germany, Ecuador, Estonia, Spain, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, Poland, Singapore, Turkey |
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