What is Entacapone Teva?
Entacapone Teva is a medicine that contains the active substance entacapone, it is available as brown tablets (200 mg).
Entacapone Teva is a 'generic medicine', which means that Entacapone Teva is similar to a 'reference medicine' already authorized in the European Union (EU) called Comtess.
What is Entacapone Teva used for?
Entacapone Teva 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. Entacapone Teva is used in combination with levodopa (or in combination with levodopa and benserazide or in combination with levodopa and carbidopa) in patients who have 'fluctuations' towards the end of the time interval between two doses. Fluctuations occur. when the effects of the medicine wear off and symptoms return. The fluctuations are linked to a reduction in the effects of levodopa, when the patient suddenly switches from "on" phases, in which he is able to move, to "off" phases, you have difficulty moving in. Entacapone Teva is used when such fluctuations cannot be treated with the standard levodopa combination alone.
The medicine can only be obtained with a prescription.
How is Entacapone Teva used?
Entacapone Teva 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 medicine, up to a maximum of 10 tablets per day. The medicine can be taken on a full or empty stomach. When starting treatment with Entacapone Teva in addition to the medicine you are already taking, it may be necessary to reduce the daily dose of levodopa, either by changing its frequency of administration or by reducing the amount of levodopa taken at each dose. Entacapone Teva can only be used in traditional combinations of levodopa. It should not be used with "modified release" preparations (ie when levodopa is released slowly over a few hours).
How does Entacapone Teva work?
In patients with Parkinson's disease, the brain cells that produce the neurotransmitter dopamine begin to die, resulting in a decrease in the concentration of dopamine in the brain. Patients therefore lose the ability to reliably control their movements. The active substance in Entacapone Teva, entacapone, helps restore dopamine levels in the areas of the brain responsible for controlling movement and coordination. It only works when given in combination with levodopa, a copy of the neurotransmitter dopamine that can be taken by mouth. Entacapone blocks an enzyme involved in the absorption of levodopa in the body called catechol-O-methyltransferase (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 Entacapone Teva been studied?
Since Entacapone Teva is a generic medicine, the patient studies have been limited to evidence to show that the medicine is bioequivalent to the reference medicine Comtess. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.
What are the benefits and risks of Entacapone Teva?
Because Entacapone Teva is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are assumed to be the same as those of the reference medicine.
Why has Entacapone Teva been approved?
The CHMP concluded that, in accordance with EU requirements, Entacapone Teva has been shown to have comparable quality and to be bioequivalent to Comtess. Therefore, the CHMP considered that, as in the case of Comtess, the benefits outweighed the identified risks. Committee recommended that Entacapone Teva be given marketing authorization.
Other information about Entacapone Teva
On 18 February 2011, the European Commission released Teva Pharma B.V.a "Marketing Authorization" for Entacapone Teva, valid throughout the European Union. The "Marketing Authorization" is valid for five years, after which it can be renewed. For more information on Entacapone Teva therapy, read the package leaflet (also enclosed with the EPAR) or contact your doctor or pharmacist.
The information on Entacapone Teva 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.
