Active ingredients: Asenapine
Sycrest 5 mg sublingual tablets.
Sublingual tablet.
Round, white to off-white, sublingual tablets debossed with “5” on one side.
Each sublingual tablet contains 5 mg asenapine (as maleate).
For the full list of excipients, see section 6.1.
The mechanism of action of asenapine is not fully understood. However, based on its receptor pharmacology, it is proposed that the efficacy of asenapine is mediated through a combination of antagonist activity at D2 and 5-HT2A receptors. Actions at other receptors e.g. 5-HT1A, 5-HT1B, 5-HT2C, 5-HT6, 5-HT7, D3, and a2-adrenergic receptors, may also contribute to the clinical effects of asenapine.
Gelatin
Mannitol (E421)
Peelable aluminium/aluminium blisters in cartons of 20, 60 or 100 sublingual tablets per carton.
Not all pack sizes may be marketed.
N.V. Organon, Kloosterstraat 6, NL-5349 AB Oss, The Netherlands
EU/1/10/640/001
EU/1/10/640/002
EU/1/10/640/003
Date of first authorisation: 01 September 2010
Date of latest renewal: 05 May 2015