This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine.
If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis for the CHMP recommendations, read the scientific discussion (also part of the EPAR).
- What is Rivastigmine Sandoz?
Rivastigmine Sandoz is a medicine containing the active substance rivastigmine. It is available as capsules (yellow: 1.5 mg; orange: 3 mg; red: 4.5 mg; red and orange: 6 mg) and as an oral solution (2 mg/ml).
This medicine is the same as the capsules and oral solution of Exelon, a medicine that is already authorised in the European Union (EU). The company that makes Exelon has agreed that its scientific data can be used for Rivastigmine Sandoz (‘informed consent’).
- What is Rivastigmine Sandoz used for?
Rivastigmine Sandoz is used for the treatment of patients with mild to moderately severe Alzheimer’s dementia, a progressive brain disorder that gradually affects memory, intellectual ability and behaviour. Rivastigmine Sandoz is also used to treat mild to moderately severe dementia in patients with Parkinson’s disease.
The medicine can only be obtained with a prescription.
- How is Rivastigmine Sandoz used?
Treatment with Rivastigmine Sandoz should be initiated and supervised by a doctor who has experience in the diagnosis and treatment of Alzheimer’s disease or dementia in patients with Parkinson’s disease. Treatment should only be started if a caregiver is available who will regularly monitor the use of Rivastigmine Sandoz by the patient. Treatment should continue as long as the medicine has a benefit, but the dose can be reduced or treatment interrupted if the patient has side effects.
Rivastigmine Sandoz should be given twice a day, with morning and evening meals. The capsules should be swallowed whole. The starting dose is 1.5 mg twice a day. In patients who tolerate this dose, it can be increased in 1.5-mg steps no more frequently than every two weeks, to a regular dose of 3 to 6 mg twice a day. The highest tolerated dose should be used to get the maximum benefit, but the dose should not exceed 6 mg twice a day.
- How does Rivastigmine Sandoz work?
The active substance in Rivastigmine Sandoz, rivastigmine, is an antidementia medicine. In patients with Alzheimer’s dementia or dementia due to Parkinson’s disease, certain nerve cells die in the brain, resulting in low levels of the neurotransmitter acetylcholine (a chemical that allows nerve cells to communicate with each other). Rivastigmine works by blocking the enzymes that break down acetylcholine: acetylcholinesterase and butyrylcholinesterase. By blocking these enzymes, Rivastigmine Sandoz allows levels of acetylcholine to be increased in the brain, helping to reduce the symptoms of Alzheimer’s dementia and dementia due to Parkinson’s disease.
- How has Rivastigmine Sandoz been studied?
Rivastigmine Sandoz has been studied in three main studies involving 2,126 patients with mild to moderately severe Alzheimer’s disease. Rivastigmine Sandoz was also studied in 541 patients with dementia due to Parkinson’s disease. All of the studies lasted six months and compared the effects of Rivastigmine Sandoz with those of placebo (a dummy treatment). The main measures of effectiveness were the change in symptoms in two main areas: cognitive (the ability to think, learn and remember) and global (a combination of several areas including general function, cognitive symptoms, behaviour and the ability to carry out everyday activities).
An additional study in 27 patients was used to show that Rivastigmine Sandoz capsules and oral solution produced similar levels of the active substance in the blood.
- What benefit has Rivastigmine Sandoz shown during the studies?
Rivastigmine Sandoz was more effective than placebo at controlling symptoms. In the three studies of Rivastigmine Sandoz in patients with Alzheimer’s dementia, patients taking doses of Rivastigmine Sandoz between 6 and 9 mg per day had an average increase in cognitive symptoms of 0.2 points from a baseline of 22.9 points at the start of the study, where a lower score indicates better performance. This was compared with an increase of 2.6 points from 22.5 in the patients taking placebo. For the global score, patients taking Rivastigmine Sandoz had an increase in symptoms of 4.1 points, compared with 4.4 in those taking placebo.
The patients with dementia due to Parkinson’s disease taking Rivastigmine Sandoz capsules showed an improvement in cognitive symptoms of 2.1 points, compared with a worsening of 0.7 points in those taking placebo, from a baseline of around 24 points. The global symptom score also improved more in the patients taking Rivastigmine Sandoz.
- What is the risk associated with Rivastigmine Sandoz?
The types of side effects seen with Rivastigmine Sandoz depend on the type of dementia it is being used to treat. Overall, the most common side effects (seen in more than 1 patient in 10) include nausea (feeling sick, seen in 38 patients in 100) and vomiting (seen in 23 patients in 100), particularly during the phase when the dose of Rivastigmine Sandoz is being increased. For the full list of all side effects reported with Rivastigmine Sandoz, see the package leaflet.
Rivastigmine Sandoz must not be used in people who are hypersensitive (allergic) to rivastigmine, other carbamate derivatives or any of the other ingredients. It must also not be used in patients who are suspected to have had in the past an allergic reaction called ‘allergic contact dermatitis’ to Exelon patch.
- Why has Rivastigmine Sandoz been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that Rivastigmine Sandoz has a modest effectiveness in treating the symptoms of Alzheimer’s dementia, although this does reflect an important benefit in some patients. The Committee initially concluded that for the treatment of dementia due to Parkinson’s disease, Rivastigmine Sandoz’s benefits did not outweigh its risks. However, following a re-examination of this opinion, the Committee concluded that the medicine’s modest effectiveness could also be of benefit to some patients.
Therefore, the Committee decided that Rivastigmine Sandoz’s benefits are greater than its risks for the treatment of mild to moderately severe Alzheimer’s dementia and mild to moderately severe dementia in patients with idiopathic Parkinson’s disease. The Committee recommended that Rivastigmine Sandoz be given marketing authorisation.
- Other information about Rivastigmine Sandoz:
The European Commission granted a marketing authorisation valid throughout the European Union for Rivastigmine Sandoz on 11 December 2009. This authorisation was based on the authorisation granted to Exelon in 1998 (‘informed consent’).
For more information about treatment with Rivastigmine Sandoz, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
This EPAR was last updated on 07/09/2016 .
16/08/2016 Rivastigmine Sandoz -EMEA/H/C/001183 -IB/0023/G
- 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.
Symptomatic treatment of mild to moderately severe Alzheimer's dementia.
Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson's disease.
Changes since initial authorisation of medicine
|Name||Language||First published||Last updated|
|Rivastigmine Sandoz : EPAR - Procedural steps taken and scientific information after authorisation||SV = svenska||2010-12-16||2016-09-07|
|Rivastigmine Sandoz-H-C-PSUSA-00002654-201501 : Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation||SV = svenska||2016-01-12|
Initial marketing-authorisation documents
|Name||Language||First published||Last updated|
|Rivastigmine Sandoz : EPAR - Public assessment report||SV = svenska||2009-12-21|
|Committee for medicinal products for human use, summary of positive opinion for Rivastigmine Sandoz||SV = svenska||2009-09-25|
This medicine is approved for use in the European Union