Memantine LEK

memantine

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This is a summary of the European public assessment report (EPAR) for Memantine LEK. It explains how the European Medicines Agency assessed the medicine to recommend its authorisation in the European Union (EU) and its conditions of use. It is not intended to provide practical advice on how to use Memantine LEK.

For practical information about using Memantine LEK, patients should read the package leaflet or contact their doctor or pharmacist.

What is Memantine LEK and what is it used for?

Memantine LEK is a medicine used to treat patients with moderate to severe Alzheimer’s disease, a type of dementia (a brain disorder) that gradually affects memory, intellectual ability and behaviour. It contains the active substance memantine.

Memantine LEK is a ‘generic medicine’. This means that Memantine LEK is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Ebixa.

How is Memantine LEK used?

Memantine LEK is available as 10-mg and 20-mg tablets and can only be obtained with a prescription.

Treatment should be started and supervised by a doctor who has experience in the diagnosis and treatment of Alzheimer’s disease. Treatment should only be started if a caregiver is available who will regularly monitor the use of Memantine LEK by the patient.

Memantine LEK should be given once a day at the same time every day. To prevent side effects, the dose of Memantine LEK is gradually increased over the first three weeks of treatment: during the first week, the dose is 5 mg; in the second week, it is 10 mg; and during the third week, it is 15 mg. From week four onwards, the recommended maintenance dose is 20 mg once a day. The tolerance and dose should be assessed within three months after starting treatment, and from then on the benefits of continuing treatment with Memantine LEK should be reassessed on a regular basis. The dose may need to be reduced in patients who have moderate or severe problems with their kidneys.

For more information, see the package leaflet.

How does Memantine LEK work?

The active substance in Memantine LEK, memantine, is an antidementia medicine. The cause of Alzheimer’s disease is unknown, but memory loss in the disease is believed to be due to a disturbance of message signals in the brain.

Memantine works by blocking special types of receptor called N-methyl-D-aspartate (NMDA) receptors, to which the neurotransmitter glutamate normally attaches. Neurotransmitters are chemicals in the nervous system that allow nerve cells to communicate with one another. Changes in the way glutamate transmits signals within the brain have been linked to the memory loss seen in Alzheimer’s disease. In addition, overstimulation of the NMDA receptors may result in 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 LEK been studied?

Because Memantine LEK is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Axura. 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 LEK?

Because Memantine LEK 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 is Memantine LEK approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Memantine LEK has been shown to have comparable quality and to be bioequivalent to Axura. Therefore, the CHMP’s view was that, as for Axura, the benefit outweighs the identified risk. The Committee recommended that Memantine LEK be approved for use in the EU.

What measures are being taken to ensure the safe and effective use of Memantine LEK?

Safety information has been included in the summary of product characteristics and the package leaflet for Memantine LEK, including the appropriate precautions to be followed by healthcare professionals and patients.

Other information about Memantine LEK

The European Commission granted a marketing authorisation valid throughout the European Union for Memantine LEK on 22 April 2013.

For more information about treatment with Memantine LEK, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Memantine LEK : EPAR - Summary for the public BG = bălgarski 2013-04-29  
Memantine LEK : EPAR - Summary for the public ES = español 2013-04-29  
Memantine LEK : EPAR - Summary for the public CS = čeština 2013-04-29  
Memantine LEK : EPAR - Summary for the public DA = dansk 2013-04-29  
Memantine LEK : EPAR - Summary for the public DE = Deutsch 2013-04-29  
Memantine LEK : EPAR - Summary for the public ET = eesti keel 2013-04-29  
Memantine LEK : EPAR - Summary for the public EL = elliniká 2013-04-29  
Memantine LEK : EPAR - Summary for the public EN = English 2013-04-29  
Memantine LEK : EPAR - Summary for the public FR = français 2013-04-29  
Memantine LEK : EPAR - Summary for the public IT = italiano 2013-04-29  
Memantine LEK : EPAR - Summary for the public LV = latviešu valoda 2013-04-29  
Memantine LEK : EPAR - Summary for the public LT = lietuvių kalba 2013-04-29  
Memantine LEK : EPAR - Summary for the public HU = magyar 2013-04-29  
Memantine LEK : EPAR - Summary for the public MT = Malti 2013-04-29  
Memantine LEK : EPAR - Summary for the public NL = Nederlands 2013-04-29  
Memantine LEK : EPAR - Summary for the public PL = polski 2013-04-29  
Memantine LEK : EPAR - Summary for the public PT = português 2013-04-29  
Memantine LEK : EPAR - Summary for the public RO = română 2013-04-29  
Memantine LEK : EPAR - Summary for the public SK = slovenčina 2013-04-29  
Memantine LEK : EPAR - Summary for the public SL = slovenščina 2013-04-29  
Memantine LEK : EPAR - Summary for the public FI = suomi 2013-04-29  
Memantine LEK : EPAR - Summary for the public SV = svenska 2013-04-29  

This EPAR was last updated on 02/02/2018 .

Authorisation details

Product details

Product details for Memantine LEK
NameMemantine LEK
Agency product numberEMEA/H/C/002630
Active substance

memantine hydrochloride

International non-proprietary name (INN) or common name

memantine

Therapeutic area Alzheimer Disease
Anatomical therapeutic chemical (ATC) code N06DX01
Generic

A generic medicine is a medicine which is similar to a medicine that has already been authorised (the 'reference medicine'). A generic medicine contains the same quantity of active substance(s) as the reference medicine. Generic and reference medicines are used at the same dose to treat the same disease, and they are equally safe and effective.

Publication details

Publication details for Memantine LEK
Marketing-authorisation holder

Pharmathen S.A.

Revision4
Date of issue of marketing authorisation valid throughout the European Union22/04/2013

Contact address:

Pharmathen S.A.
6, Dervenakion str.
15351 Pallini
Attiki
Greece

Product information

Product information

08/01/2018  Memantine LEK -EMEA/H/C/002630 -R/0009

Name Language First published Last updated
Memantine LEK : EPAR - Product Information SV = svenska 2013-04-29 2018-02-02
Memantine LEK : EPAR - Product Information SV = svenska 2013-04-29 2018-02-02
Memantine LEK : EPAR - Product Information SV = svenska 2013-04-29 2018-02-02
Memantine LEK : EPAR - Product Information SV = svenska 2013-04-29 2018-02-02
Memantine LEK : EPAR - Product Information SV = svenska 2013-04-29 2018-02-02
Memantine LEK : EPAR - Product Information SV = svenska 2013-04-29 2018-02-02
Memantine LEK : EPAR - Product Information SV = svenska 2013-04-29 2018-02-02
Memantine LEK : EPAR - Product Information SV = svenska 2013-04-29 2018-02-02
Memantine LEK : EPAR - Product Information SV = svenska 2013-04-29 2018-02-02
Memantine LEK : EPAR - Product Information SV = svenska 2013-04-29 2018-02-02
Memantine LEK : EPAR - Product Information SV = svenska 2013-04-29 2018-02-02
Memantine LEK : EPAR - Product Information SV = svenska 2013-04-29 2018-02-02
Memantine LEK : EPAR - Product Information SV = svenska 2013-04-29 2018-02-02
Memantine LEK : EPAR - Product Information SV = svenska 2013-04-29 2018-02-02
Memantine LEK : EPAR - Product Information SV = svenska 2013-04-29 2018-02-02
Memantine LEK : EPAR - Product Information SV = svenska 2013-04-29 2018-02-02
Memantine LEK : EPAR - Product Information SV = svenska 2013-04-29 2018-02-02
Memantine LEK : EPAR - Product Information SV = svenska 2013-04-29 2018-02-02
Memantine LEK : EPAR - Product Information SV = svenska 2013-04-29 2018-02-02
Memantine LEK : EPAR - Product Information SV = svenska 2013-04-29 2018-02-02
Memantine LEK : EPAR - Product Information SV = svenska 2013-04-29 2018-02-02
Memantine LEK : EPAR - Product Information SV = svenska 2013-04-29 2018-02-02
Memantine LEK : EPAR - Product Information SV = svenska 2013-04-29 2018-02-02
Memantine LEK : EPAR - Product Information SV = svenska 2013-04-29 2018-02-02
Memantine LEK : EPAR - Product Information SV = svenska 2013-04-29 2018-02-02

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Memantine LEK : EPAR - All Authorised presentations SV = svenska 2013-04-29 2013-08-16
Memantine LEK : EPAR - All Authorised presentations SV = svenska 2013-04-29 2013-08-16
Memantine LEK : EPAR - All Authorised presentations SV = svenska 2013-04-29 2013-08-16
Memantine LEK : EPAR - All Authorised presentations SV = svenska 2013-04-29 2013-08-16
Memantine LEK : EPAR - All Authorised presentations SV = svenska 2013-04-29 2013-08-16
Memantine LEK : EPAR - All Authorised presentations SV = svenska 2013-04-29 2013-08-16
Memantine LEK : EPAR - All Authorised presentations SV = svenska 2013-04-29 2013-08-16
Memantine LEK : EPAR - All Authorised presentations SV = svenska 2013-04-29 2013-08-16
Memantine LEK : EPAR - All Authorised presentations SV = svenska 2013-04-29 2013-08-16
Memantine LEK : EPAR - All Authorised presentations SV = svenska 2013-04-29 2013-08-16
Memantine LEK : EPAR - All Authorised presentations SV = svenska 2013-04-29 2013-08-16
Memantine LEK : EPAR - All Authorised presentations SV = svenska 2013-04-29 2013-08-16
Memantine LEK : EPAR - All Authorised presentations SV = svenska 2013-04-29 2013-08-16
Memantine LEK : EPAR - All Authorised presentations SV = svenska 2013-04-29 2013-08-16
Memantine LEK : EPAR - All Authorised presentations SV = svenska 2013-04-29 2013-08-16
Memantine LEK : EPAR - All Authorised presentations SV = svenska 2013-04-29 2013-08-16
Memantine LEK : EPAR - All Authorised presentations SV = svenska 2013-04-29 2013-08-16
Memantine LEK : EPAR - All Authorised presentations SV = svenska 2013-04-29 2013-08-16
Memantine LEK : EPAR - All Authorised presentations SV = svenska 2013-04-29 2013-08-16
Memantine LEK : EPAR - All Authorised presentations SV = svenska 2013-04-29 2013-08-16
Memantine LEK : EPAR - All Authorised presentations SV = svenska 2013-04-29 2013-08-16
Memantine LEK : EPAR - All Authorised presentations SV = svenska 2013-04-29 2013-08-16
Memantine LEK : EPAR - All Authorised presentations SV = svenska 2013-04-29 2013-08-16
Memantine LEK : EPAR - All Authorised presentations SV = svenska 2013-04-29 2013-08-16

Pharmacotherapeutic group

Psychoanaleptics; Other antidementia drugs

Therapeutic indication

Treatment of patients with moderate to severe Alzheimer’s disease.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Memantine LEK : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 2013-08-16 2018-02-02

Initial marketing-authorisation documents

Name Language First published Last updated
Memantine LEK : EPAR - Public assessment report SV = svenska 2013-04-29  
CHMP summary of positive opinion for Memantine LEK SV = svenska 2013-02-25  

Authorised

This medicine is approved for use in the European Union

More information on Memantine LEK