Source: European Medicines Agency (EU) Revision Year: 2018 Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Exelon 4.6 mg/24 h transdermal patch.
Exelon 9.5 mg/24 h transdermal patch.
Exelon 13.3 mg/24 h transdermal patch.
| Pharmaceutical Form |
|---|
|
Transdermal patch. Exelon 4.6 mg/24 h transdermal patch: Each transdermal patch is a thin, matrix-type transdermal patch consisting of three layers. The outside of the backing layer is beige and labelled with “Exelon”, “4.6 mg/24 h” and “AMCX”. Exelon 9.5 mg/24 h transdermal patch: Each transdermal patch is a thin, matrix-type transdermal patch consisting of three layers. The outside of the backing layer is beige and labelled with “Exelon”, “9.5 mg/24 h” and “BHDI”. Exelon 13.3 mg/24 h transdermal patch: Each transdermal patch is a thin, matrix-type transdermal patch consisting of three layers. The outside of the backing layer is beige and labelled with “Exelon”, “13.3 mg/24 h” and “CNFU”. |
Exelon 4.6 mg/24 h transdermal patch: Each transdermal patch releases 4.6 mg of rivastigmine per 24 hours. Each transdermal patch of 5 cm² contains 9 mg of rivastigmine.
Exelon 9.5 mg/24 h transdermal patch: Each transdermal patch releases 9.5 mg of rivastigmine per 24 hours. Each transdermal patch of 10 cm² contains 18 mg of rivastigmine.
Exelon 13.3 mg/24 h transdermal patch: Each transdermal patch releases 13.3 mg of rivastigmine per 24 hours. Each transdermal patch of 15 cm² contains 27 mg of rivastigmine.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Rivastigmine |
Rivastigmine is an acetyl- and butyrylcholinesterase inhibitor of the carbamate type, thought to facilitate cholinergic neurotransmission by slowing the degradation of acetylcholine released by functionally intact cholinergic neurones. Thus, rivastigmine may have an ameliorative effect on cholinergic-mediated cognitive deficits in dementia associated with Alzheimer’s disease and Parkinson’s disease. |
| List of Excipients |
|---|
|
Backing layer: Polyethylene terephthalate film, lacquered Medicinal product matrix: Alpha-tocopherol Adhesive matrix: Alpha-tocopherol Release liner: Polyester film, fluoropolymer-coated |
Each child-resistant sachet is made of a paper/polyester/aluminium/polyacrylonitrile multilaminated material. One sachet contains one transdermal patch.
Exelon 4.6 mg/24 h transdermal patch: Available in packs containing 7, 30 or 42 sachets and in multipacks containing 60, 84 or 90 sachets.
Exelon 9.5 mg/24 h transdermal patch: Available in packs containing 7, 30 or 42 sachets and in multipacks containing 60, 84 or 90 sachets.
Exelon 13.3 mg/24 h transdermal patch: Available in packs containing 7 or 30 sachets and in multipacks containing 60 or 90 sachets.
Not all pack sizes may be marketed.
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Exelon 4.6 mg/24 h transdermal patch:
EU/1/98/066/019-022
EU/1/98/066/031-032
Exelon 9.5 mg/24 h transdermal patch:
EU/1/98/066/023-026
EU/1/98/066/033-034
Exelon 13.3 mg/24 h transdermal patch:
EU/1/98/066/027-030
Date of first authorisation: 12 May 1998
Date of latest renewal: 20 May 2008
| Drug | Countries | |
|---|---|---|
| EXELON | Austria, Australia, Brazil, Canada, Cyprus, Germany, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Italy, Japan, Lithuania, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa |
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