What is Pramipexole Teva?
Pramipexole Teva is a medicine that contains the active substance pramipexole base. It is available as white oval tablets (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 medicine', 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 which causes tremor, slow 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 later 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 are taken with water, with or without food. The starting 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 decreased gradually.
For further information, see the package leaflet.
How does Pramipexole Teva work?
The active ingredient in Pramipexole Teva, pramipexole is a dopamine agonist that mimics the action of dopamine. Dopamine is a message-carrying substance contained in the brain areas that control movement and coordination. In patients with the disease. of Parkinson's, the dopamine-producing cells begin to die, resulting in a decrease in the amount of dopamine in the brain. Patients therefore lose the ability to reliably control their movements. Pramipexole stimulates the brain just as dopamine would. , allowing patients to control their movements and reduce the signs and symptoms of Parkinson's disease, including tremors, stiffness and slowed movement.
How has Pramipexole Teva been studied?
Since Pramipexole Teva is a generic medicine, the studies have been limited to tests to determine that the medicine 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?
Since Pramipexole Teva is a generic medicine and is bioequivalent to the reference medicine, the benefits and risks of the medicine are assumed 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 case of Siprol, the benefits outweigh the identified risks. The Committee recommended that Pramipexole Teva be given a Marketing Authorization.
Other information about Pramipexole Teva
On 18 December 2008, the European Commission released Teva Pharma B.V. a "Marketing Authorization" for Pramipexole Teva, valid throughout the European Union.
Last update of this summary: 11-2008
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