What is Prometax?
Prometax is a medicine containing 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 within 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 dementia. This type of dementia is a progressive brain disorder that gradually compromises 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 started if a person is available to assist the patient, who can regularly monitor the patient's intake of the drug. Treatment should be continued until a therapeutic benefit is found, but the dose may be reduced or treatment stopped in the presence of side effects.
Prometax capsules or oral solution should be administered twice a day, for breakfast and dinner. The capsules should be swallowed whole. The initial 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 one adjustment and another, until reaching a regular dose of 3-6 mg twice per day. To achieve maximum therapeutic benefit, patients must take the highest well tolerated dose. The maximum recommended dose is 6 mg twice a day.
In the case of transdermal patches, the 4.6 mg patch should initially be applied for 24 hours. Subsequently, after at least four weeks of treatment and provided that the lowest dose has been well tolerated, the patch can be switched from 9.5 mg / 24 hours. The patch should be applied to clean, dry, hairless and intact skin of the back, arm or chest, and should be replaced every 24 hours.
hours. The patch should not be applied to reddened or irritated skin, on the thigh or abdomen (belly) or in a position where it can be rubbed by tight clothing. The patch does not come off in case of sweating due to heat or while bathing. You can switch from taking 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 antidementia medicine. In patients with dementia of the Alzheimer type 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 enzymes that degrade acetylcholine: acetylcholinesterase and butyrylcholinesterase. By blocking these enzymes, Prometax promotes increased levels of acetylcholine in the brain and thus helps reduce the symptoms of Alzheimer's dementia and dementia associated with Parkinson's disease.
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 examined in one main study involving 1, 195 patients. Prometax capsules have also been studied in 541 patients with dementia associated with Parkinson's disease. All studies lasted six months and compared the effects of Prometax with those of placebo (a dummy treatment). The main indicators of effectiveness were the variation of symptoms in two main areas: cognitive (ability to think, learn and remember) and global (a combination of different areas including general functioning, cognitive symptoms, behavior and capacity of carry out daily activities).
An additional study carried out on 27 patients was used to show that the formulations of Prometax capsules and oral solution produced similar concentrations of the active ingredient 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 Prometax doses ranging from 6 to 9 mg per day showed an average increase in cognitive symptoms of 0.2 points, starting from a value of 22, 9 points at the beginning of the study; the lower the score, the better the result achieved by the therapy. By comparison, an increase of 2.6 points from a starting value of 22.5 was observed in placebo-treated patients. Regarding the global score, patients taking Prometax capsules reported an increase in symptoms of 4.1 points compared to 4.4 points recorded in subjects treated with placebo. Prometax transdermal patches also proved 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 observed in subjects who took 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 undesirable effects observed with Prometax depend on the type of dementia that you want to treat and the formula given (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 Prometax dose is increased. For the full list of all side effects reported with Prometax, see the Package Leaflet.
Prometax should 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 given to patients with severe hepatic impairment.
Why has Prometax been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that Prometax has modest efficacy in the treatment of symptoms of Alzheimer's dementia, although this results in an important benefit for some patients. Initially the committee decided that, for 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 dementia and mild to moderately severe dementia in patients with idiopathic Parkinson's disease and therefore recommended granting of the marketing authorization for the product.
Further information on Prometax:
On 4 December 1998, the European Commission granted a marketing authorization valid throughout the European Union for Prometax to Novartis Europharm Limited. The marketing authorization was renewed on 4 December 2003 and 4 December 2008.
The full EPAR for Prometax can be found here.
Last update of this summary: 05-2008.
