What is Marixino (Maruxa) - memantine hydrochloride and what is it used for?
Marixino is a medicine used in the treatment of patients with moderate to severe Alzheimer's disease, a type of dementia (a neurological disorder) that gradually affects memory, intellectual capacity and behavior. It contains the active substance memantine hydrochloride . Marixino is a "generic medicine". This means that Marixino 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 Marixino (Maruxa) - memantine hydrochloride used?
Marixino 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 a person is available to assist the patient, who regularly monitors the use of Marixino by the patient. Marixino should be given once a day, at the same time each day. To avoid side effects, the dose of Marixino 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 within three months of starting treatment and a regular assessment of the beneficial effects of continued treatment with Marixino is required. 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 Marixino (Maruxa) - memantine hydrochloride work?
The active substance in Marixino, memantine, is an antidementia medicine. The cause of Alzheimer's disease is not known, however it is believed that memory loss during the course of the disease is due to a disturbance in the transmission of signals in 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, 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.
How has Marixino (Maruxa) - memantine hydrochloride been studied?
The company presented data on the solubility, composition and absorption of the medicine in the body. No further studies on patients were necessary because Marixino has been shown to have comparable quality and was considered bioequivalent to the reference medicine, Ebixa. "Bioequivalent" means that medicines should produce the same levels of active ingredient in the body.
What are the benefits and risks of Marixino (Maruxa) - memantine hydrochloride?
Because Marixino is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are considered to be the same as those of the reference medicine.
Why has Marixino (Maruxa) - memantine hydrochloride been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Marixino 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 Marixino in the EU.
What measures are being taken to ensure the safe and effective use of Marixino (Maruxa) - memantine hydrochloride?
Safety information has been included in the summary of product characteristics and the package leaflet for Marixino, including the appropriate precautions to be followed by healthcare professionals and patients.
More information on Marixino (Maruxa) - memantine hydrochloride
On 29 April 2013, the European Commission issued a marketing authorization for Marixino, valid throughout the European Union. On 9 August 2013 the name of the medicine was changed to Marixino. For more information on Marixino 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: 08-2013.
