White to off-white, oval tablets with a length of 16 mm and a width of 8 mm, marked with "300" on one side, and "BAYER" on the other side.
Each film-coated tablet contains 300 mg of darolutamide.
Excipient with known effect: Each film-coated tablet contains 186 mg of lactose monohydrate (see Precautions).
Excipients/Inactive Ingredients: Tablet core: Calcium hydrogen phosphate (E 341), Croscarmellose sodium, Lactose monohydrate, Magnesium stearate (E 470b), Povidone (E 1201).
Film-coating: Hypromellose, Lactose monohydrate, Macrogol (E 1521), Titanium dioxide (E 171).