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Human medicines European public assessment report (EPAR): Aripiprazole Zentiva, aripiprazole, Date of authorisation: 25/06/2015, Revision: 10, Status: Authorised

Aripiprazole Zentiva is available as tablets (5, 10, 15 and 30 mg) and orodispersible tablets (tablets that dissolve in the mouth; 10, 15 and 30 mg). It can only be obtained with a prescription.

For schizophrenia, the recommended starting dose is 10 or 15 mg by mouth per day in adults, followed by a ‘maintenance’ dose of 15 mg once a day. In patients aged between 15 and 17 years, the starting dose is 2 mg a day (using an aripiprazole product available in liquid form), which is gradually increased to the recommended dose of 10 mg once a day.

For treating manic episodes in bipolar disorder, the recommended starting dose in adults is 15 mg by mouth once a day, either on its own or in combination with other medicines. To prevent manic episodes in adults, the same dose should be continued.

For treating manic episodes in patients aged between 13 and 17 years, the starting dose is 2 mg a day (using an aripiprazole product available in liquid form), which is gradually increased to the recommended dose of 10 mg once a day. Treatment must not last longer than 12 weeks.

The dose should be adjusted in patients who are taking other medicines that affect the way Aripiprazole Zentiva is broken down in the body. For further information, see the Summary of Product Characteristics (also part of the EPAR).

The orodispersible tablets can be used in patients who have difficulty swallowing tablets.

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