What is Memantine Mylan - memantine and what is it used for?
Memantine Mylan is a medicine used to treat patients with moderate to severe Alzheimer's disease. Alzheimer's disease is a type of dementia (a mental disorder) that gradually affects memory, intellectual capacity and behavior. It contains the active substance memantine . Memantine Mylan is a "generic medicine". This means that Memantine Mylan is similar to a "reference drug" already authorized in the European Union (EU) called Ebixa. For more information on generic medicines, see the questions and answers by clicking here.
How is Memantine Mylan - memantine used?
Memantine Mylan is available as 10 mg and 20 mg tablets and can only be obtained with a prescription. Treatment should be initiated and supervised by a physician experienced in the diagnosis and treatment of Alzheimer's disease. Therapy should only be started if it is possible to rely on the assistance of a person who regularly monitors the patient's use of Memantine Mylan. Memantine Mylan should be given once a day, always at the same time. To reduce the risk of side effects, the dose of Memantine Mylan is gradually increased over the first three weeks of treatment: the dose is 5 mg for the first week, 10 mg for the second week and 15 mg for the third week . Starting from the fourth week, the recommended maintenance dose is 20 mg once a day. Tolerance and dose should be evaluated three months after the start of treatment. From that moment on, the benefits of continuing Memantine Mylan therapy should be reviewed regularly. In patients with moderate or severe kidney problems it may be necessary to reduce the dose. For more information see the package leaflet
How does Memantine Mylan - memantine work?
The active substance in Memantine Mylan, memantine, is an antidementia medicine. The cause of Alzheimer's disease is not known, however it is believed that the memory loss associated with it is due to a disturbance in the transmission of signals within the brain. Memantine works by blocking particular types of receptor, called NMDA receptors, to which glutamate, a neurotransmitter, is normally bound. Neurotransmitters are chemicals in the nervous system that allow nerve cells to communicate with each other. Alterations in the way that glutamate transmits signals within the brain have been related to the memory loss observed in Alzheimer's disease. Furthermore, an over-stimulation of NMDA receptors can cause damage or cell death. By blocking NMDA receptors, memantine improves the transmission of signals in the brain and reduces the symptoms of Alzheimer's disease.
What studies have been performed on Memantine Mylan - memantine?
Because Memantine Mylan is a generic medicine, studies in patients have been limited to tests to determine its bioequivalence to the reference medicine, Ebixa. Two medicines are bioequivalent when they produce the same levels of active ingredient in the body.
What are the benefits and risks of Memantine Mylan - memantine?
Because Memantine Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are considered to be the same as the reference medicine's.
Why has Memantine been approved - memantine?
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Memantine Mylan has been shown to have comparable quality and to be bioequivalent to Ebixa. Therefore, the CHMP considered that, as in the case of Ebixa, the benefits outweigh the identified risks and recommended to approve the use of Memantine Mylan in the EU.
What measures are being taken to ensure the safe and effective use of Memantine Mylan - memantine?
Safety information has been included in the summary of product characteristics and the package leaflet for Memantine Mylan, including the appropriate precautions to be followed by healthcare professionals and patients.
More information on Memantine Mylan - memantine
On 22 April 2013, the European Commission issued a marketing authorization for Memantine Mylan, valid throughout the European Union. For more information about Memantine Mylan therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. The full EPAR for the reference medicine can also be found on the Agency's website. Last update of this summary: 04-2013.
