What is Prometax?
Prometax 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), as an oral solution (2 mg / ml) and as transdermal patches that release 4.6 mg or 9.5 mg of rivastigmine through the skin over 24 hours.
What is Prometax used for?
Prometax capsules, oral solution and transdermal patches are used in the treatment of patients with mild to moderately severe Alzheimer's type dementia. This type of dementia is a progressive brain disorder that gradually impairs memory, intellectual ability and behavior.
The capsules and oral solution 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 Prometax used?
Treatment 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 caregiver is available who can regularly monitor the patient's intake of the drug. Treatment should be continued until therapeutic benefit is seen, but the dose can be reduced or discontinued treatment in the presence of side effects.
Prometax capsules or oral solution should be administered twice a day, with breakfast and dinner. The capsules should be swallowed whole. The starting dose is 1.5 mg twice a day. If this dose is well tolerated, it can be increased by 1.5 mg at a time, respecting the time interval of at least two weeks between adjustments, until a regular dose of 3-6 mg twice a day is reached. day. To achieve maximum therapeutic benefit, patients should take the highest well tolerated dosage. The maximum recommended dose is 6 mg twice a day.
In the case of transdermal patches, the 4.6 mg patch should be applied initially for 24 hours. Subsequently, after at least four weeks of treatment and provided the lower dose has been well tolerated, the 9 patch can be changed. 5 mg / 24 hours. The patch should be applied to clean, dry, hairless and intact skin on the back, arm or chest, and should be replaced every 24 hours.
hours. The patch should not be applied to red or irritated skin, on the thigh or abdomen (tummy) or in a location where it can be rubbed by tight clothing. The patch does not come off if you sweat from heat or when bathing. You can switch from taking the capsules or oral solution to using the patches. For more detailed information, see the Summary of Product Characteristics, included in the EPAR.
How does Prometax work?
The active substance in Prometax, rivastigmine, is an anti-dementia medicine. In patients with Alzheimer's-type dementia or with dementia associated with Parkinson's disease, some nerve cells in the brain die, resulting in a decrease in the concentration 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 inhibiting these enzymes, Prometax promotes the increase of acetylcholine levels in the brain and thus helps to reduce the symptoms of Alzheimer's-type dementia and dementia associated with the disease. Parkinson's.
How has Prometax been studied?
Prometax has been studied in mild to moderately severe Alzheimer's disease. The capsules were studied in 2 126 patients in three main studies, while the transdermal patches were studied in one main study involving 1 195 patients. Prometax capsules were also studied in 541 patients with dementia associated with Parkinson's disease. . All the studies lasted six months and compared the effects of Prometax with those of placebo (a dummy treatment). The main indicators of effectiveness were the change in symptoms in two main areas: cognitive (ability to think, learning and remembering) and global (a combination of different domains including general functioning, cognitive symptoms, behavior and the ability to perform daily activities).
An additional study in 27 patients was used to show that the Prometax capsule and oral solution formulations produced similar concentrations of the active substance in the blood.
What benefit has Prometax shown during the studies?
Prometax was more effective than placebo at controlling symptoms. In the three studies performed with Prometax capsules in patients with Alzheimer's syndrome, subjects taking doses of Prometax between 6 and 9 mg per day had an average increase in cognitive symptoms of 0.2 points, starting from a value of 22. , 9 points at the start of the study; the lower the score, the better the outcome of the therapy. By comparison, an increase of 2.6 points from a baseline of 22.5 was observed in patients treated with placebo. . With regard to the overall score, patients taking Prometax capsules reported an increase in symptoms of 4.1 points compared to 4.4 points for those taking placebo. Prometax transdermal patches were also more effective than placebo. in slowing the worsening of dementia.
Patients with dementia associated with Parkinson's disease treated with Prometax capsules showed an improvement in cognitive symptoms of 2.1 points compared to the worsening of 0.7 points seen in subjects taking placebo, starting from a baseline value of 24 points. The overall symptom score also improved more in patients taking Prometax.
What is the risk associated with Prometax?
The types of side effects seen with Prometax depend on the type of dementia you want to treat and the formulation administered (capsules, oral solution or transdermal patches).Overall, the most common side effects (seen in more than 1 in 10 patients) include nausea and vomiting, especially during the phase when the dose of Prometax is increased. For the full list of side effects reported with Prometax, see the package leaflet.
Prometax must not be used in people who may be hypersensitive (allergic) to rivastigmine, other carbamate derivatives or any of the other ingredients of the medicine. It must also not be used in patients with severe hepatic insufficiency.
Why has Prometax been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that Prometax has "modest efficacy in treating the symptoms of Alzheimer's dementia, although this results in an important benefit for some patients. The Committee had originally decided that, for the in the treatment of dementia associated with Parkinson's disease, the benefits of Prometax did not outweigh its risks. However, after a review of its opinion, the Committee concluded that the efficacy of the medicine, albeit modest, could benefit some patients. .
Therefore, the Committee decided that Prometax's benefits are greater than its risks for the symptomatic treatment of mild to moderately severe Alzheimer's type dementia and mild to moderately severe dementia in patients with idiopathic Parkinson's disease and therefore recommended the release of the authorization for the placing on the market of the product.
Other information about Prometax:
On 4 December 1998, the European Commission granted Novartis Europharm Limited a "Marketing Authorization" for Prometax, valid throughout the European Union. The "Marketing Authorization" was renewed on 4 December 2003 and 4 December 2008.
For the full version of Prometax EPAR click here.
Last update of this summary: 05-2008.
The information on Prometax - rivastigmine 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.
