What is Memantine ratiopharm - memantine hydrochloride and what is it used for?
Memantine ratiopharm is a medicine that contains the active substance memantine hydrochloride. It is used in the treatment of patients with moderate to severe Alzheimer's disease. Alzheimer's disease is a type of dementia (a neurological disorder) that gradually affects memory, brainpower and behavior. Memantine ratiopharm is a 'generic medicine'. This means that Memantine ratiopharm is similar to a 'reference medicine' already authorized in the European Union (EU) called Ebixa.
How is Memantine ratiopharm used?
Memantine ratiopharm 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 the assistance of a person can be sought who regularly monitors the patient's intake of Memantine ratiopharm. Memantine ratiopharm should be administered once a day at the same time each day. To prevent the onset of side effects, the dose of Memantine ratiopharm 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 assessed three months after starting treatment. From then on, the benefits of continuing therapy with Memantine ratiopharm should be reassessed regularly. In patients with moderate or severe kidney problems it may be necessary to reduce the For further information, see package leaflet
How does Memantine ratiopharm - memantine hydrochloride work?
The active substance in Memantine ratiopharm, memantine hydrochloride, 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, to which glutamate, a neurotransmitter, normally attaches. . 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 observed in the disease. Alzheimer's. Furthermore, overstimulation of NMDA receptors can cause cell damage or death. By blocking NMDA receptors, mema
How has Memantine ratiopharm - memantine hydrochloride been studied?
As Memantine ratiopharm 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 ratiopharm - memantine hydrochloride?
Because Memantine ratiopharm 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 ratiopharm - memantine hydrochloride been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Memantine ratiopharm 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 ratiopharm be approved for use in the EU.
What measures are being taken to ensure the safe and effective use of Memantine ratiopharm - memantine hydrochloride?
Safety information has been added to the summary of product characteristics and package leaflet for Memantine ratiopharm, including the appropriate precautions to be followed by healthcare professionals and patients.
Other information about Memantine ratiopharm - memantine hydrochloride
On 13 June 2013, the European Commission granted a "Marketing Authorization" for Memantine ratiopharm, valid throughout the European Union. For more information on therapy with Memantine ratiopharm, please 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: June 2013.
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