What is Oprymea?
Oprymea is a medicine that contains the active substance pramipexole base. It is available as white tablets (round: 0.088 mg, 0.7 mg and 1.1 mg; oval: 0.18 mg and 0.35 mg).
Oprymea is a generic medicine. This implies that it is similar to a 'reference medicine' already authorized in the European Union (EU) called Sifrol (also known as Mirapexin). For more information on generic medicines, please see the questions and answers by clicking here.
What is Oprymea used for?
Oprymea is used to treat Parkinson's disease, a progressive mental disorder which causes tremor, slow movement and muscle stiffness. Oprymea 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 Oprymea used?
Oprymea 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. Oprymea should be given less frequently in patients with kidney problems. If for any reason the treatment is stopped, the dose should be decreased gradually.
For more information, see the package leaflet.
How does Oprymea work?
The active substance in Oprymea, 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. Parkinson's, the dopamine-producing cells begin to die, resulting in a decrease in the amount of dopamine in the brain. Patients then 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 Oprymea been studied?
Because Oprymea is a generic medicine, the studies have limited themselves to showing that the medicine is bioequivalent to the reference medicines (which produce the same levels of the active substance in the body).
What is the risk associated with Oprymea?
Because Oprymea 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 Oprymea been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with the requirements of EU legislation, Oprymea 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 that Oprymea be given marketing authorization.
More information about Oprymea
On 12 September 2008, the European Commission granted KRKA, d.d., Novo mesto a "marketing authorization" for Oprymea, valid throughout the European Union.
For the full evaluation version (EPAR) of Oprymea, click here.
The full EPAR version of the reference medicine can also be found on the EMEA website.
Last update of this summary: 07-2008.
The information on Oprymea - pramipexolo base 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.
