What is Pramipexole Accord - Pramipexole?
Pramipexole Accord is a medicine that contains the active substance pramipexole. It is available as tablets (from 0.088; 0.18; 0.35; 0.7 and 1.1 mg).
Pramipexole Accord is a "generic medicine". This means that Pramipexole Accord is similar to a "reference medicine" already authorized in the European Union (EU) called Mirapexin.
What is Pramipexole Accord - Pramipexole used for?
Pramipexole Accord is used to treat the symptoms of the following diseases:
Parkinson's disease, which is a progressive mental disorder that causes tremor, slowness of movement and muscle stiffness; Pramipexole Accord 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 decreases;
moderate to severe restless leg syndrome (a disorder that irrepressibly pushes the legs to stop feelings of discomfort, pain or discomfort felt in the body, especially at night); Pramipexole Accord is used when a specific cause of the disorder cannot be identified.
The medicine can only be obtained with a prescription.
How is Pramipexole Accord - Pramipexole used?
For Parkinson's disease, the initial dosage is one tablet of 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 corresponds to three 1.1 mg tablets. Pramipexole Accord should be given less frequently in patients who have problems with their kidneys. If for any reason the treatment is stopped, the dose should be gradually decreased.
In the treatment of restless legs syndrome, Pramipexole Accord should be taken once a day, two or three hours before bedtime. The recommended starting dose is 0.088 mg, but, if necessary, it can be increased every 4-7 days to further reduce the symptoms, up to a maximum of 0.54 mg. The patient's response and the need for further treatment should be evaluated after three months.
Pramipexole Accord tablets should be taken with water. For more information, see the package leaflet.
How does Pramipexole Accord - Pramipexole work?
The active substance in Pramipexole Accord, pramipexole, is a dopamine agonist (a substance that mimics the action of dopamine). Dopamine is a messenger substance contained in brain districts that control movement and coordination. In patients suffering from Parkinson's disease there is a loss of dopamine-producing cells, so a reduction in the amount of this substance present in the brain results in a deterioration of the individual's ability to control 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.
The mechanism of action of pramipexole in restless legs syndrome is not yet fully known. This syndrome is thought to be caused by alterations in the functioning of dopamine in the brain, which can be corrected with pramipexole.
How has Pramipexole Accord - Pramipexole been studied?
Because Pramipexole Accord is a generic medicine, studies have been limited to tests to show that it is bioequivalent to the reference medicine Mirapexin. Two medicines are bioequivalent when they produce the same levels of active ingredient in the body.
What are the benefits and risks of Pramipexole Accord - Pramipexole?
Because Pramipexole Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are considered to be the same as those of the reference medicine.
Why has Pramipexole Accord - Pramipexole been approved?
The CHMP concluded that, in accordance with EU requirements, Pramipexole Accord has been shown to have comparable quality and to be bioequivalent / comparable to Mirapexin. It is therefore the opinion of the CHMP that, as in the case of Mirapexin, the benefits outweigh the identified risks. The Committee therefore recommended that Pramipexole Accord be given marketing authorization.
Further information on Pramipexole Accord - Pramipexole
On 30 September 2011, the European Commission issued a marketing authorization for Pramipexole Accord, valid throughout the European Union.
For more information about treatment with Pramipexole Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
The full EPAR for the reference medicine can be found on the Agency's website.
Last update of this summary: 08/2011.
