Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: RAD Neurim Pharmaceuticals EEC SARL, 4 rue de Marivaux, 75002 Paris, France, e-mail: regulatory@neurim.com
Slenyto 1 mg prolonged-release tablets.
Slenyto 5 mg prolonged-release tablets.
| Pharmaceutical Form |
|---|
|
Prolonged-release tablet. Slenyto 1 mg prolonged-release tablets: Pink, film coated, round, biconvex, 3 mm diameter tablets with no imprint. Slenyto 5 mg prolonged-release tablets: Yellow, film coated, round, biconvex, 3 mm diameter tablets with no imprint. |
Each prolonged-release tablet contains 1 mg melatonin.
Excipient with known effect: Each prolonged-release tablet contains lactose monohydrate equivalent to 8.32 mg lactose.
Each prolonged-release tablet contains 5 mg melatonin.
Excipient with known effect: Each prolonged-release tablet contains lactose monohydrate equivalent to 8.86 mg lactose.
For the full list of excipients, see section 6.1.
| Active Ingredient |
|---|
|
Melatonin is a naturally occurring hormone produced by the pineal gland and is structurally related to serotonin. Physiologically, melatonin secretion increases soon after the onset of darkness, peaks at 2-4 am and diminishes during the second half of the night. Melatonin is associated with the control of circadian rhythms and entrainment to the light-dark cycle. It is also associated with a hypnotic effect and increased propensity for sleep. |
| List of Excipients |
|---|
Slenyto 1 mg prolonged-release tabletTablet core: Ammonio methacrylate copolymer type B Film coating: Carmellose sodium (E466) Slenyto 5 mg prolonged-release tabletTablet core: Ammonio methacrylate copolymer type A Film coating: Carmellose sodium (E466) |
Slenyto 1 mg prolonged-release tablets: PVC/PVDC opaque blister with aluminium foil backing. Pack size: 30 tablets or 60 tablets.
Slenyto 5 mg prolonged-release tablets: PVC/PVDC opaque blister with aluminium foil backing. Pack size: 30 tablets.
Not all pack sizes may be marketed.
RAD Neurim Pharmaceuticals EEC SARL, 4 rue de Marivaux, 75002 Paris, France, e-mail: regulatory@neurim.com
EU/1/18/1318/001
EU/1/18/1318/003
EU/1/18/1318/005
Date of first authorisation: 20 September 2018
Date of latest renewal: 5 June 2023
| Drug | Countries | |
|---|---|---|
| SLENYTO | Austria, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Italy, Lithuania, New Zealand, Poland, United Kingdom |
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