What is Pramipexole Teva?
Pramipexole Teva is a medicine that contains the active substance pramipexole base. It is available in white oval tablets (from 0.088, 0.18, 0.35 and 0.7 mg). Pramipexole Teva is a "generic medicine". This implies that Pramipexole Teva is similar to a "reference drug" already authorized in the European Union (EU) called Sifrol. For more information on generic medicines, see the questions and answers by clicking here.
What is Pramipexole Teva used for?
Pramipexole Teva is used to treat Parkinson's disease, a progressive mental disorder that causes tremor, slowness of movement and muscle stiffness. Pramipexole Teva can be used alone or in combination with levodopa (another medicine for Parkinson's disease), at any stage of the disease including the final stages when the effect of levodopa becomes less effective.
The medicine can only be obtained with a prescription.
How is Pramipexole Teva used?
Pramipexole Teva tablets should be taken with water, with or without food. The initial dose is 0.088 mg three times a day. Every five to seven days the dose should be increased until symptoms are controlled without causing side effects that cannot be tolerated. The maximum daily dose is 1.1 mg three times a day. Pramipexole Teva should be given less frequently to patients with kidney problems. If for any reason the treatment is stopped, the dose should be gradually decreased.
For more information, see the package leaflet.
How does Pramipexole Teva work?
The active substance in Pramipexole Teva, pramipexole is a dopamine agonist that mimics the action of dopamine. Dopamine is a substance responsible for the transmission of messages, contained in the brain districts that control movement and coordination. In patients with Parkinson's disease, dopamine-producing cells begin to die, resulting in a decrease in the amount of dopamine present in the brain. Patients therefore lose the ability to control their movements reliably. Pramipexole stimulates the brain as well as dopamine, allowing patients to control their movements and reduce the signs and symptoms of Parkinson's disease, including tremors, stiffness and slowed movements.
What studies have been carried out on Pramipexole Teva?
Because Pramipexole Teva is a generic medicine, studies have been limited to tests to determine that the drug is bioequivalent to the reference medicine (ie that the two medicines produce the same levels of the active substance in the body).
What are the benefits and risks of Pramipexole Teva?
Because Pramipexole Teva is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are supposed to be the same.
Why has Pramipexole Teva been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with the requirements of EU legislation, Pramipexole Teva has been shown to have comparable quality and to be bioequivalent to Sifrol. The CHMP is therefore of the opinion that, as in the case of Siprol, the benefits outweigh the identified risks. The Committee recommended the granting of a marketing authorization for Pramipexole Teva.
More information on Pramipexole Teva
On 18 December 2008, the European Commission granted a marketing authorization valid throughout the European Union to Teva Pharma BV for Pramipexole Teva.
Last update of this summary: 11-2008
