Transcription of ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
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ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT ABILIFY 5 mg tablets ABILIFY 10 mg tablets ABILIFY 15 mg tablets ABILIFY 30 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ABILIFY 5 mg tablets Each tablet contains 5 mg of aripiprazole. Excipient with known effect mg lactose (as monohydrate) per tablet ABILIFY 10 mg tablets Each tablet contains 10 mg of aripiprazole. Excipient with known effect mg lactose (as monohydrate) per tablet ABILIFY 15 mg tablets Each tablet contains 15 mg of aripiprazole. Excipient with known effect mg lactose (as monohydrate) per tablet ABILIFY 30 mg tablets Each tablet contains 30 mg of aripiprazole. Excipient with known effect mg lactose (as monohydrate) per tablet For the full list of excipients, see section 3.
with severe hepatic impairment, the data available are insufficient to establish recommendations. In these patients dosing should be managed cautiously. However, the maximum daily dose of 30 mg should be used with caution in patients with severe hepatic impairment (see section 5.2).
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