What is Memantine Mylan 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, brainpower and behavior. Contains the active substance memantine.Memantine Mylan is a 'generic medicine'. This means that Memantine Mylan is similar to a 'reference medicine' 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 used - memantine?
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. Treatment should only be initiated if the assistance of a person can be sought who regularly monitors the patient's intake of Memantine Mylan. Memantine Mylan should be administered once a day at the same time each day. 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. From the fourth week, the recommended maintenance dose is 20 mg once daily. Tolerance and dose should be evaluated three months after starting treatment. The benefits of continuing Memantine Mylan therapy should be reviewed regularly thereafter. In patients with moderate or severe kidney problems the dose may need to be reduced. For further information see the package leaflet
How does Memantine Mylan - memantine work?
The active substance in Memantine Mylan, memantine, is an anti-dementia medicine. The cause of Alzheimer's disease is not known, however the associated memory loss is thought to be due to a disturbance in the transmission of signals within the brain. Memantine works by blocking particular types of receptors, called NMDA receptors, at which normally binds glutamate, a neurotransmitter. Neurotransmitters are chemicals in the nervous system that allow nerve cells to communicate with each other. Alterations in how glutamate transmits signals within the brain have been placed in relationship with memory loss observed in Alzheimer's disease. Additionally, overstimulation of NMDA receptors can cause cell damage or death. By blocking NMDA receptors, memantine improves the transmission of signals in the brain and reduces the symptoms of Alzheimer's disease.
How has Memantine Mylan - memantine been studied?
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 the active substance 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 taken as being the same as the reference medicine's.
Why has Memantine Mylan - memantine been approved?
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 that Memantine Mylan be approved for use in the EU.
What measures are being taken to ensure the safe and effective use of Memantine Mylan - memantine?
Safety information has been added to the summary of product characteristics and package leaflet for Memantine Mylan, including the appropriate precautions to be followed by healthcare professionals and patients.
Other information about Memantine Mylan - memantine
On 22 April 2013, the European Commission granted a "Marketing Authorization" for Memantine Mylan, valid throughout the European Union. For more information on therapy with Memantine Mylan, read the package leaflet (included with the EPAR) or consult your doctor or pharmacist. The full EPAR version of the reference medicine can also be found on the Agency's website. Last update of this summary: 04-2013.
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