Transcription of PRODUCT INFORMATION - Medicines
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PRODUCT INFORMATION - Medicines
valdoxan (agomelatine 25 mg) PRODUCT INFORMATION 1 (17) Version 18 PRODUCT INFORMATION NAME OF THE MEDICINE valdoxan Agomelatine 25mg DESCRIPTION The active component of valdoxan is agomelatine which has the chemical name: N-[2-(7-methoxy-1-naphthyl)ethyl] acetamide. Agomelatine is practically insoluble in purified water (< mg/mL) but freely soluble (> 100 mg/mL) in various organic solvents (96% ethanol, methanol, methylene chloride). Agomelatine has no asymmetric carbon atom. CAS Registry Number: 138112-76-2 Molecular formula: C15H17NO2 (MW = ). Chemical structure: Excipients: Lactose monohydrate, maize starch, povidone, sodium starch glycollate, stearic acid, magnesium stearate, colloidal anhydrous silica, hypromellose, iron oxide yellow (CI77492), glycerol, macrogol 6000, and titanium dioxide (CI77891), shellac, indigo carmine (CI73015), propylene glycol.
VALDOXAN® (agomelatine 25 mg) – Product Information 3 (17) Version 18 increased in women compared to men. Although not clinically relevant, the bioavailability is increased by intake of oral contraceptives and reduced by smoking.
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