Human medicines European public assessment report (EPAR): Memantine Mylan, memantine, Date of authorisation: 21/04/2013, Revision: 11, Status: Authorised
Memantine Mylan is available as 10-mg and 20-mg tablets and can only be obtained with a prescription.
Treatment should be started and supervised by a doctor who has experience in the diagnosis and treatment of Alzheimer’s disease. Treatment should only be started if a caregiver is available who will regularly monitor the use of Memantine Mylan by the patient.
Memantine Mylan should be given once a day at the same time every day. To prevent side effects, the dose of Memantine Mylan is gradually increased over the first three weeks of treatment: during the first week, the dose is 5 mg; in the second week, it is 10 mg; and during the third week, it is 15 mg. From week four onwards, the recommended maintenance dose is 20 mg once a day. The tolerance and dose should be assessed within three months after starting treatment, and from then on the benefits of continuing treatment with Memantine Mylan should be reassessed on a regular basis. The dose may need to be reduced in patients who have moderate or severe problems with their kidneys.
For more information, see the package leaflet.
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