What is Rivastigmine Actavis?
Rivastigmine Actavis is a medicine containing the active substance rivastigmine, available in capsule form (yellow: 1.5 mg; orange: 3 mg; red: 4.5 mg; red and orange: 6 mg).
Rivastigmine Actavis is a 'generic medicine'. This means that Rivastigmine Actavis is similar to a 'reference medicine' already authorized in the European Union (EU) called Exelon.
What is Rivastigmine Actavis used for?
Rivastigmine Actavis 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 Actavis used?
Treatment with Rivastigmine Actavis should be initiated under the supervision of a qualified physician experienced in the diagnosis and treatment of Alzheimer's disease or dementia associated with Parkinson's disease. Treatment should only be started in the presence of a carer who can check that Rivastigmine Actavis is being taken regularly. Treatment should continue as long as the medicine has a beneficial effect, but the dose can be reduced or the therapy stopped if the patient experiences side effects.
Rivastigmine Actavis 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 1.5 mg increments, at intervals of not less than two weeks, to a regular dose of 3-6 mg twice daily. To achieve maximum therapeutic benefit, patients should be maintained at the highest well tolerated dosage. However, the maximum recommended dose should not exceed 6 mg twice a day.
How does Rivastigmine Actavis work?
The active substance in Rivastigmine Actavis, rivastigmine, is an anti-dementia medicine. In patients with Alzheimer's type dementia or dementia due to Parkinson's disease certain nerve cells die inside the brain; this causes a lowering of the levels of acetylcholine, a neurotransmitter (ie a chemical that allows nerve cells to communicate with each other) . Rivastigmine works by blocking acetylcholinesterase and butyrylcholinesterase, the enzymes that break down acetylcholine. By blocking these enzymes, Rivastigmine Actavis promotes an increase in acetylcholine levels in the brain, which helps to relieve the symptoms of dementia-type Alzheimer's and dementia due to Parkinson's disease.
How has Rivastigmine Actavis been studied?
As Rivastigmine Actavis is a generic medicine, the studies have been limited to evidence to show that the medicine is bioequivalent to the reference medicine, ie Exelon. Two medicines are considered bioequivalent when they produce the same levels of the active substance in the body.
What are the risks and benefits associated with Rivastigmine Actavis during the studies?
Because Rivastigmine Actavis is a generic medicine and is bioequivalent to the reference medicine, it is considered to have the same benefits and risks as the reference medicine.
Why has Rivastigmine Actavis been approved?
The CHMP (Committee for Medicinal Products for Human Use) concluded that, in accordance with EU requirements, Rivastigmine Actavis has been shown to have comparable quality and to be bioequivalent to Exelon. Therefore being of the opinion that as in the reference medicine the benefits are than the identified risks, the Committee recommended the granting of a marketing authorization for Rivastigmine Actavis.
Other information about Rivastigmine Actavis
On June 16, 2011, the European Commission granted Actavis Group PTC ehf a "marketing authorization" for Rivastigmina Actavis, valid throughout the European Union. The "marketing authorization" is valid for five years, after which can be renewed.
For more information on Rivastigmine Actavis therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.
The full EPAR version of the reference medicine can be found on the Agency's website.
Last update of this summary: 05-2011.
The information on Rivastigmina Actavis 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.
