What is Memantine Accord - memantine and what is it used for?
Memantine Accord is a medicine that contains the active substance memantine . It is used to treat patients with moderate to severe Alzheimer's disease. Alzheimer's disease is a type of dementia (a brain disorder) that gradually affects memory, intellectual capacity and behavior. Memantine Accord is a "generic" medicine. This means that Memantine Accord is similar to a 'reference medicine' already authorized in the European Union (EU) called Axura. For more information on generic medicines, see the questions and answers by clicking here.
How is Memantine Accord - memantine used?
Memantine Accord is available as tablets (5 mg, 10 mg, 15 mg and 20 mg) 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 started if an assistant is available to regularly verify the use of Memantine Accord by the patient. Memantine Accord should be given once a day, always at the same time. To avoid side effects, the dose of Memantine Accord is gradually increased over the first three weeks of treatment: the daily 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 Accord therapy should be reviewed regularly. In patients with moderate or severe kidney problems it may be necessary to reduce the dose.
How does Memantine Accord work - memantine?
The active substance in Memantine Accord, 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 receptors, called N-methyl-D-aspartate (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. 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 Accord - memantine?
The company provided data on the solubility, composition and absorption of the medicine in the body. No further studies in patients have been requested as Memantine Accord has been shown to be of comparable quality and is considered bioequivalent to the reference medicine, Axura. "Bioequivalent" means that medicines should produce the same levels of active ingredient in the body.
What are the benefits and risks of Memantine Accord - memantine?
Because Memantine Accord 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 Accord - memantine been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Memantine Accord has been shown to have comparable quality and is considered bioequivalent to Axura. Therefore, the CHMP considered that, as in the case of Axura, the benefits outweigh the identified risks and recommended to approve the use of Memantine Accord in the EU.
What measures are being taken to ensure the safe and effective use of Memantine Accord - memantine?
A risk management plan has been developed to ensure that Memantine Accord is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Memantine Accord, including the appropriate precautions to be followed by healthcare professionals and patients.
More information about Memantine Accord - memantine
On 4 December 2013, the European Commission issued a marketing authorization for Memantine Accord, valid throughout the European Union.
For more information about treatment with Memantine Accord, 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: 12-2013.
