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, slowness of 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 the administration of two doses. Fluctuations occur when the effects of the medicine run out and the symptoms recur. Fluctuations are linked to a reduction in the effects of levodopa, when the patient suddenly goes from "on" phases, in which he is able to move, to "off" phases, in which he has difficulty in movement. Entacapone Teva is used when these fluctuations cannot be treated with the standard combination based on levodopa 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 with or without food. When you start treatment with Entacapone Teva in addition to the medicine you are already taking, you may need to reduce your daily dose of levodopa, either by changing the frequency of administration or by reducing the amount of levodopa you take 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 within a few hours).
How does Entacapone Teva work?
In patients with Parkinson's disease, the brain cells that produce the dopamine neurotransmitter begin to die, resulting in a decrease in dopamine concentration in the brain. Patients therefore lose the ability to control their movements reliably. The active ingredient in Entacapone Teva, 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 dopamine neurotransmitter 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 remains active longer, helping to improve the symptoms of Parkinson's disease, such as stiffness and slowness in movement.
What studies have been performed on Entacapone Teva?
Because Entacapone Teva is a generic medicine, studies in patients have been limited to tests to show that it is bioequivalent to the reference medicine, Comtess. Two medicines are bioequivalent when they produce the same levels of active ingredient 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 taken as being the same as those of the reference medicine.
Why has Entacapone Teva been approved?
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. The Committee recommended the granting of a marketing authorization for Entacapone Teva.
Other information on Entacapone Teva
On 18 February 2011, the European Commission granted Teva Pharma BV 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 about treatment with Entacapone Teva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
