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Each film-coated tablet contains 40 mg, 30 mg, or 20 mg of Afatinib (=free base) corresponding to 59.12 mg, 44.34 mg, or 29.56 mg 2-butenamide, N-[4-[3(-chloro-4-fluorophenyl)amino]-7-[[(3S)-tetrahydro-3-furanyl]oxy]-6-quinazolinyl]-4-(dimethylamino)-,(2E)-, (2Z)- 2-butenedioate (1:2) (= afatinib dimaleate).
Excipients/Inactive Ingredients: Tablet Core: Lactose monohydrate, microcrystalline cellulose (E460), colloidal anhydrous silica (E551), crospovidone, magnesium stearate (E470b).
Film Coating: Hypromellose 2910 (E464), macrogol 400, titanium dioxide (E171), talc (E553b), polysorbate 80 (E433), colourant containing indigo carmine (E132), aluminium hydroxide (only used for 40 mg and 30 mg tablets).
