PLEASE NOTE: MEDICINAL PRODUCT IS NO LONGER AUTHORIZED
What is Rivastigmine Teva?
Rivastigmine Teva is a medicine that contains the active substance rivastigmine. It is 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, see the questions and answers by clicking here.
What is RivastigmineTeva used for?
Rivastigmine Teva is used to treat patients with mild to moderately severe Alzheimer's 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 started 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 habitually assists the patient) who regularly controls the patient's intake of the medicine is available. Treatment should be maintained until the medicine has a beneficial effect, but the dose can be reduced or treatment stopped if the patient experiences side effects.
Rivastigmine Teva should be given twice a day, for breakfast and dinner. The capsules must be swallowed whole. The initial dose is 1.5 mg twice a day. If this dose is well tolerated, it may be increased, in 1.5 mg increments at intervals of not less than two weeks, to a regular dose of 3-6 mg twice a day. To get the maximum benefit it is good to use the highest tolerated dose, without exceeding 6 mg twice a day.
How does Rivastigmine Teva work?
The active substance in Rivastigmine Teva, rivastigmine, is an antidementia medicine. In patients with dementia of the Alzheimer type or dementia due to Parkinson's disease some nerve cells die in the brain resulting in lowering the levels of the neurotransmitter acetylcholine (a chemical that allows nerve cells to communicate with each other). Rivastigmine works by blocking the enzymes that destroy acetylcholine, ie acetylcholinesterase and butyrylcholinesterase. By blocking these enzymes, Rivastigmine Teva promotes increased levels of acetylcholine in the brain, which helps reduce the symptoms of Alzheimer's dementia and dementia due to Parkinson's disease.
What studies have been performed on Rivastigmine Teva?
Because Rivastigmine Teva is a generic medicine, studies have been limited to tests to show that the drug 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 taken as being 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 opinion that, as with Exelon, the benefits outweigh the identified risks. The Committee recommended the granting of a marketing authorization for Rivastigmine Teva.
More information on Rivastigmine Teva
The European Commission granted a marketing authorization valid throughout the European Union for Rivastigmine Teva to Teva Pharma BV on 17 April 2009.
The full EPAR for Rivastigmine Teva can be found here.
The full EPAR of the reference medicine is also found on the EMEA website.
Last update of this summary: 02-2009.
