Fycompa Description

Film-coated tablet: 2 mg tablet: Orange, round, biconvex tablet, debossed with Є275 on one side and '2' on the other side.
4 mg tablet: Red, round, biconvex tablet, debossed with Є277 on one side and '4' on the other side.
8 mg tablet: Purple, round, biconvex tablet, debossed with Є295 on one side and '8' on the other side.
Each film-coated tablet contains 2, 4, 8 mg perampanel.
Oral suspension: White to off-white suspension.
Each ml of oral suspension contains 0.5 mg perampanel.
Each bottle of 340 ml contains 170 mg perampanel.
Excipient with known effect: Each ml of oral suspension contains 175 mg sorbitol (E420).
Excipients/Inactive Ingredients: Film-coated tablet: 2 mg tablet: Core: Perampanel, lactose monohydrate, low-substituted-hydroxypropyl cellulose, povidone, magnesium stearate.
Film coating: OPADRY ORANGE (containing): Hypromellose 2910, talc, Macrogol 8000, titanium dioxide, ferric oxide yellow, ferric oxide red.
4 mg tablet: Core: Perampanel, lactose monohydrate, low-substituted-hydroxypropyl cellulose, povidone, magnesium stearate.
Film coating: OPADRY RED (containing): Hypromellose 2910, talc, Macrogol 8000, titanium dioxide, ferric oxide red.
8 mg tablet: Core: Perampanel, lactose monohydrate, low-substituted-hydroxypropyl cellulose, povidone, microcrystalline cellulose, magnesium stearate.
Film coating: OPADRY PURPLE (containing): Hypromellose 2910, talc, Macrogol 8000, titanium dioxide, ferric oxide red, ferric oxide black.
Oral suspension: Sorbitol (E420) liquid (crystallising); Microcrystalline cellulose (E460); Carmellose sodium (E466); Poloxamer 188; Simethicone emulsion 30%, containing purified water, silicone oil, polysorbate 65, methylcellulose, silica gel, macrogol stearate, sorbic acid, benzoic acid and sulfuric acid; Anhydrous citric acid (E330); Sodium benzoate (E211); Purified water.