PLEASE NOTE: MEDICINAL PRODUCT NO LONGER AUTHORIZED
What is Rivastigmina Teva?
Rivastigmine Teva is a medicine that contains the active substance rivastigmine. It comes in the form of capsules (white: 1.5 mg; pink: 3 mg; orange: 4.5 mg; orange and pink: 6 mg).
Rivastigmine Teva is a 'generic medicine'. This means that Rivastigmine Teva is similar to a 'reference medicine' already authorized in the European Union (EU) called Exelon. For more information on generic medicines, please see the questions and answers by clicking here.
What is Rivastigmine Teva used for?
Rivastigmine Teva is used to treat patients with mild to moderately severe Alzheimer's type dementia, a progressive brain disease that gradually affects memory, intellectual ability and behavior. It can also be used for the treatment of mild to moderately severe dementia in patients with Parkinson's disease.
The medicine can only be obtained with a prescription.
How is Rivastigmine Teva used?
Treatment with Rivastigmine Teva should be initiated and supervised by a doctor experienced in the diagnosis and treatment of Alzheimer's disease or dementia associated with Parkinson's disease. Therapy should only be started if a 'caregiver' (the one who usually cares for the patient) is available to regularly monitor the patient's intake of the medicine. Treatment should be continued as long as the medicine has a beneficial effect, but it can be reduce the dose or discontinue treatment if the patient experiences side effects.
Rivastigmine Teva should be administered twice a day, with breakfast and dinner. The capsules must be swallowed whole. The starting dose is 1.5 mg twice a day. If this dose is well tolerated, it may be increased in increments of 1.5 mg at intervals of not less than two weeks to a regular dose of 3-6 mg twice daily. For maximum benefit, use the highest tolerated dose, but do not exceed 6 mg twice daily.
How does Rivastigmine Teva work?
The active substance in Rivastigmine Teva, rivastigmine, is an anti-dementia medicine. In patients with Alzheimer's-type dementia or dementia due to Parkinson's disease, some nerve cells die in the brain resulting in lower levels of the neurotransmitter acetylcholine (the chemical that allows nerve cells to communicate with each other). Rivastigmine works by blocking the enzymes that destroy acetylcholine, namely acetylcholinesterase and butyrylcholinesterase. By blocking these enzymes, Rivastigmine Teva promotes an increase in acetylcholine levels in the brain, which helps reduce the symptoms of Alzheimer's-type dementia and Parkinson's disease dementia.
How has Rivastigmine Teva been studied?
Since Rivastigmine Teva is a generic medicine, the studies have been limited to evidence to show that the medicine is bioequivalent to the reference medicine (ie that the two medicines produce the same levels of the active substance in the body).
What are the benefits and risks of Rivastigmine Teva?
Because Rivastigmine Teva 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 Rivastigmine Teva been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Rivastigmine Teva has been shown to have comparable quality and to be bioequivalent to Exelon. Therefore, the CHMP is of the view that, as with Exelon, the benefits outweigh the identified risks. The committee recommended that Rivastigmine Teva be given marketing authorization.
Other information about Rivastigmine Teva
On April 17, 2009, the European Commission released Teva Pharma B.V. a "marketing authorization" for Rivastigmina Teva, valid throughout the European Union.
For the full version of the Rivastigmina Teva EPAR click here.
The full EPAR version of the reference medicine can also be found on the EMEA website.
Last update of this summary: 02-2009.
The information on Rivastigmina Teva published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
