Source: European Medicines Agency (EU) Revision Year: 2018 Publisher: Merck Sharp & Dohme B.V., Waarderweg 39, 2031, BN Haarlem, The Netherlands
Aerius 5 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablets. |
Each tablet contains 5 mg desloratadine.
Excipient(s) with known effect: This medicine contains lactose.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Desloratadine |
Desloratadine is a non-sedating, long-acting histamine antagonist with selective peripheral H1-receptor antagonist activity. After oral administration, desloratadine selectively blocks peripheral histamine Η1-receptors because the substance is excluded from entry to the central nervous system. |
| List of Excipients |
|---|
|
Tablet core: Calcium hydrogen phosphate dihydrate Tablet coating: Film coat (containing lactose monohydrate, hypromellose, titanium dioxide, macrogol 400, indigotin (E132)) |
Aerius is supplied in blisters comprised of laminate blister film with foil lidding.
The materials of the blister consist of a polychlorotrifluoroethylene (PCTFE)/Polyvinyl Chloride (PVC) film (product contact surface) with an aluminium foil lidding coated with a vinyl heat seal coat (product contact surface) which is heat sealed.
Packs of 1, 2, 3, 5, 7, 10, 14, 15, 20, 21, 30, 50, 90, 100 tablets.
Not all pack sizes may be marketed.
Merck Sharp & Dohme B.V., Waarderweg 39, 2031, BN Haarlem, The Netherlands
EU/1/00/160/001-013
EU/1/00/160/036
Date of first authorisation: 15 January 2001
Date of latest renewal: 15 January 2006
| Drug | Countries | |
|---|---|---|
| AERIUS | Austria, Canada, Cyprus, Germany, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey |
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