What is Comtan?
Comtan is a medicine containing the active substance entacapone, available as orange-brown tablets (200 mg).
What is Comtan used for?
Comtan is indicated for the treatment of patients with Parkinson's disease. Parkinson's disease is a progressive mental disorder that causes tremor, slow movement, and muscle stiffness. Comtan is used in addition to levodopa (a combination of levodopa and benserazide or a combination of levodopa and carbidopa) if the patient experiences "fluctuations" towards the end of the time interval between two doses. Fluctuations occur when the effects of the drug diminish and the symptoms re-emerge. The fluctuations are related to a reduction in the effects of levodopa, whereby the patient undergoes sudden changes between the "on" state, in which he is able to move, and the "off" state , where you have difficulty moving. Comtan is given when these fluctuations cannot be stabilized with the standard preparation alone which contains levodopa.The medicine can only be obtained with a prescription.
How is Comtan used?
Comtan should only be used in combination with levodopa and benserazide or with levodopa and carbidopa. The recommended dose is one tablet taken with each dose of the associated drug, up to a maximum of 10 tablets per day. The medicine can be taken on a full or empty stomach. When patients start Comtan as an add-on to existing treatment, it may be necessary to reduce the daily levodopa dose by extending the dose interval or by using less levodopa in doses. Comtan can only be used with traditional preparations of levodopa The medicine should not be given together with 'modified release' preparations (ie when levodopa is released slowly over a few hours).
How does Comtan work?
In patients with Parkinson's disease, the brain cells that produce the neutransmitter dopamine begin to die, resulting in a decrease in the concentration of this substance in the brain. Patients therefore lose the ability to reliably control their movements. The active substance in Comtan, entacapone, helps restore dopamine levels in the areas of the brain responsible for controlling movement and coordination. It works only when given in combination with levodopa, a copy of the neutransmitter dopamine, which can be taken by mouth. Entacapone blocks an enzyme involved in the absorption of levodopa in the body called catechol-O-methyl transferase (COMT). As a result, levodopa stays active longer, helping to improve symptoms of Parkinson's disease, such as stiffness and slowness of movement.
How has Comtan been studied?
Comtan was studied in a total of 376 patients with Parkinson's disease in two six-month studies investigating the effects of administering Comtan or placebo (a dummy treatment) as add-on therapy to the preparation of levodopa and carbidopa or levodopa and benserazide already used by the patient. The main measure of effectiveness was the time spent in the "on" state (ie the time levodopa controls the symptoms of Parkinson's disease) after the first dose of levodopa in the morning in the first studio and over a day in the second studio.
What benefit has Comtan shown during the studies?
Comtan was more effective than placebo in both studies. In the first study, adding Comtan to levodopa therapy extended the "on" time by 1 hour and 18 minutes compared to placebo, while in the second study, the "on" interval increased by 35 minutes compared to placebo. to that recorded with the intake of placebo.
What are the risks associated with Comtan?
The most common side effects with Comtan (seen in 1 to 10 patients in 100) are dyskinesia (involuntary movements), nausea and harmless urine discoloration. For the full list of side effects reported with Comtan, see the Package Leaflet.
Comtan must not be used in people who may be hypersensitive (allergic) to entacapone or any of the other ingredients. Comtan must not be used in patients:
• liver diseases,
• have pheochromocytoma (a tumor of the adrenal gland);
• with a history of neuroleptic malignant syndrome (a serious nervous system disorder usually caused by antipsychotic drugs) or rhabdomyolysis (breakdown of muscle fibers);
Comtan must not be used at the same time as other medicines belonging to the group of 'monoamine oxidase inhibitors' (a type of antidepressant). For further details, please refer to the Summary of Product Characteristics, included in the EPAR.
Why has Comtan been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Comtan's benefits are greater than its risks in addition to standard levodopa / benserazide or levodopa / carbidopa preparations for the treatment of fluctuating patients with Parkinson's disease. daily "end-of-dose" motor movements and which cannot be stabilized with the aforementioned combinations, and therefore recommended the release of the "marketing authorization" of the product.
More information about Comtan
On 22 September 1998, the European Commission granted Novartis Europharm a "Marketing Authorization" for Comtan, valid throughout the European Union. The "Marketing Authorization" was renewed on 22 September 2003 and on 22 September. 2008.
For the full version of Comtan's EPAR click here.
Last update of this summary: 08-2008
The information on Comtan - entacapone 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.
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