Memantine Accord - memantine
What is Memantine Accord 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, brainpower 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, please see the questions and answers here.
How is Memantine Accord used - memantine?
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 who regularly checks the patient's use of Memantine Accord. Memantine Accord should be administered 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. From the fourth week, the recommended maintenance dose is 20 mg once daily. Tolerance and dose should be assessed three months after starting treatment. From then on, the benefits of continuing therapy with Memantine Accord should be reassessed regularly. In patients with moderate or severe kidney problems it may be necessary to reduce the dose.
How does Memantine Accord - memantine work?
The active substance in Memantine Accord, 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 N-methyl receptors. -D-aspartate (NMDA), which normally binds glutamate, a neurotransmitter. Neurotransmitters are chemicals in the nervous system that allow nerve cells to communicate with each other. Alterations in the way glutamate transmits signals within the brain have been linked to the memory loss seen 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.
How has Memantine Accord - memantine been studied?
The company provided data on the solubility, composition and absorption of the medicine in the body. No additional patient studies were required as Memantine Accord was shown to be of comparable quality and is considered to be bioequivalent to the reference medicine, Axura. “Bioequivalent” means that medicines should produce the same levels of the active substance 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 taken as being 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 to be bioequivalent to Axura. Therefore, the CHMP considered that, as in the case of Axura, the benefits outweigh the identified risks and recommended that Memantine Accord be approved for use 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 added to the summary of product characteristics and package leaflet for Memantine Accord, including the appropriate precautions to be followed by healthcare professionals and patients.
Other information about Memantine Accord - memantine
On 04 December 2013, the European Commission issued a "Marketing Authorization" for Memantine Accord, valid throughout the European Union.
For more information about Memantine Accord therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist. The full EPAR version of the reference medicine can also be found on the Agency's website. this summary: 12-2013.
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