What is Rivastigmine 1 A Pharma?
Rivastigmine 1 A Pharma is a medicine that contains 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 Exelon capsules and oral solution, which is already authorized in the European Union (EU).The company that makes Exelon has agreed that its scientific data be used for Rivastigmine 1 A Pharma (“informed consent”).
What is Rivastigmine 1 A Pharma used for?
Rivastigmine 1 A Pharma is used to treat patients with mild to moderately severe Alzheimer's type dementia, a progressive brain disease that gradually affects memory, intellectual capacity and behavior. Rivastigmine 1 A Pharma is also 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 1 A Pharma used?
Treatment with Rivastigmine 1 A Pharma should be initiated and supervised by a physician experienced in the diagnosis and treatment of Alzheimer's disease or dementia associated with Parkinson's disease. Therapy should only be initiated if a person who is habitually caring for the patient is available who regularly checks the patient's intake of Rivastigmine 1 A Pharma. Treatment should continue as long as the medicine produces a beneficial effect, but it can be reduced. dose or discontinue therapy if patient experiences side effects.
Rivastigmine 1 A Pharma 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 can 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 it is recommended to use the highest tolerated dosage, but not to exceed 6 mg twice daily.
How does Rivastigmine 1 A Pharma work?
The active substance in Rivastigmine 1 A Pharma, 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 break down acetylcholine: acetylcholinesterase and butyrylcholinesterase. By blocking these enzymes, Rivastigmine 1 A Pharma 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 1 A Pharma been studied?
Rivastigmine 1 A Pharma has been studied in three main studies involving 2,126 patients with mild to moderately severe Alzheimer's type dementia. Rivastigmine 1 A Pharma has also been studied in 541 patients with dementia due to Parkinson's disease. All the studies lasted six months and compared the effects of Rivastigmine 1 A Pharma with those of placebo (a dummy treatment). The main indicators of effectiveness were the change in symptoms in two main domains: cognitive (the ability to think, learn and remember) and global (a combination of different domains including general functioning, cognitive symptoms, behavior and ability to carry out daily activities).
A further study in 27 patients showed that Rivastigmine 1 A Pharma capsules and oral solution produce similar levels of the active substance in the blood.
What benefit has Rivastigmine 1 A Pharma shown during the studies?
Rivastigmine 1 A Pharma was more effective than placebo in controlling symptoms. In the three studies of Rivastigmine 1 A Pharma in patients with Alzheimer's type dementia, patients taking Rivastigmine 1 A Pharma doses between 6 and 9 mg per day had an average increase in cognitive symptoms of 0.2 points compared to baseline levels 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 compared to 22.5 in patients treated with placebo. overall score, in patients taking Rivastigmine 1 A Pharma there was an increase in symptoms of 4.1 points compared to 4.4 in patients taking placebo.
Patients with dementia due to Parkinson's disease taking Rivastigmine 1 A Pharma capsules showed an improvement in cognitive symptoms of 2.1 points compared with a worsening of 0.7 points in those taking placebo, starting from a baseline of approximately 24 points. In addition, the overall symptom score improved more in patients taking Rivastigmine 1 A Pharma.
What are the risks associated with Rivastigmine 1 A Pharma?
The types of side effects seen with Rivastigmine 1 A Pharma depend on the type of dementia being treated. In general, the most frequent side effects (seen in more than 1 in 10 patients) are nausea and vomiting, particularly when increasing the dose of Rivastigmine 1 A Pharma. For the full list of side effects reported with Rivastigmine 1 A Pharma, see the Package Leaflet.
Rivastigmine 1 A Pharma should not be used in people who may be hypersensitive (allergic) to rivastigmine, other carbamate derivatives or any of the other substances. It must not be used in patients with severe liver problems.
Why has Rivastigmine 1 A Pharma been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that Rivastigmine 1 A Pharma has modest efficacy in treating the symptoms of Alzheimer's-type dementia, although it does indeed show significant benefit in some patients. The committee initially concluded that, in the treatment of dementia due to Parkinson's disease, the benefits of Rivastigmine 1 A Pharma do not outweigh its risks. However, following a re-examination of this opinion, the Committee concluded that the modest efficacy of the medicine could have beneficial effects in some patients.
Therefore, the Committee decided that the benefits associated with Rivastigmine 1 A Pharma are greater than its risks in the treatment of mild to moderately severe Alzheimer's type dementia and mild to moderately severe dementia in patients with idiopathic Parkinson's disease. The committee recommended that Rivastigmine 1 A Pharma be given marketing authorization.
Other information about Rivastigmine 1 A Pharma
On 11 December 2009, the European Commission granted 1 A Pharma GmbH a "Marketing Authorization" for Rivastigmine 1 A Pharma, valid throughout the European Union. The "Marketing Authorization" is valid for five years and after this period it can be renewed.
For the full version of the Rivastigmine 1 A Pharma EPAR, click here.
Last update of this summary: 10-2009.
The information on Rivastigmine 1 A Pharma 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.
