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Pramipexole Accord

Active Substance: pramipexole dihydrochloride monohydrate
Common Name: pramipexole
ATC Code: N04BC05
Marketing Authorisation Holder: Accord Healthcare Ltd
Active Substance: pramipexole dihydrochloride monohydrate
Status: Authorised
Authorisation Date: 2011-09-30
Therapeutic Area: Restless Legs Syndrome Parkinson Disease
Pharmacotherapeutic Group: Anti-Parkinson drugs

Therapeutic Indication

Pramipexole Accord is indicated in adults for treatment of the signs and symptoms of idiopathic Parkinson's disease, alone (without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end-of-dose or 'on-off' fluctuations).

What is Pramipexole Accord?

Pramipexole Accord is a medicine that contains the active substance pramipexole. It is available as tablets (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 authorised in the European Union (EU) called Mirapexin.

What is Pramipexole Accord used for?

Pramipexole Accord is used to treat the symptoms of the following diseases:

  • Parkinson’s disease, a progressive brain disorder that causes shaking, slow movement and muscle stiffness. Pramipexole Accord can be used either on its own or in combination with levodopa (another medicine for Parkinson’s disease), at any stage of disease including the later stages when levodopa starts becoming less effective;
  • moderate to severe restless-legs syndrome, a disorder where the patient has uncontrollable urges to move the limbs to stop uncomfortable, painful or odd sensations in the body, usually at night. Pramipexole Accord is used when a specific cause for the disorder cannot be identified.

The medicine can only be obtained with a prescription.

How is Pramipexole Accord used?

For Parkinson’s disease, the starting dose is one 0.088 mg tablet three times a day. The dose should be increased every five to seven days until symptoms are controlled without causing side effects that cannot be tolerated. The maximum daily dose is three 1.1 mg tablets. Pramipexole Accord must be given less often in patients who have problems with their kidneys. If treatment is stopped for any reason, the dose should be decreased gradually.

For restless-legs syndrome, Pramipexole Accord should be taken once a day, two to three hours before going to bed. The recommended starting dose is 0.088 mg, but, if needed, this can be increased every four to seven days to reduce symptoms further, 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 should be swallowed with water. For more information, see the package leaflet.

How does Pramipexole Accord work?

The active substance in Pramipexole Accord, pramipexole, is a dopamine agonist (a substance that imitates the action of dopamine). Dopamine is a messenger substance in the parts of the brain that control movement and co-ordination. In patients with Parkinson’s disease, the cells that produce dopamine begin to die and the amount of dopamine in the brain decreases. The patients then lose their ability to control their movements reliably. Pramipexole stimulates the brain as dopamine would, so that patients can control their movement and have fewer of the signs and symptoms of Parkinson’s disease, such as shaking, stiffness and slowness of movement.

The way pramipexole works in restless-legs syndrome is not fully understood. The syndrome is thought to be caused by problems in the way dopamine works in the brain, which may be corrected by pramipexole.

How has Pramipexole Accord been studied?

Because Pramipexole Accord is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Mirapexin. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.

What are the benefits and risks of Pramipexole Accord?

Because Pramipexole Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.

Why has Pramipexole Accord been approved?

The CHMP concluded that, in accordance with EU requirements, Pramipexole Accord has been shown to have comparable quality and to be bioequivalent to Mirapexin. Therefore, the CHMP’s view was that, as for Mirapexin, the benefit outweighs the identified risk. The Committee recommended that Pramipexole Accord be given marketing authorisation.

Other information about Pramipexole Accord

The European Commission granted a marketing authorisation valid throughout the European Union for Pramipexole Accord on 30 September 2011.

For more information about treatment with Pramipexole Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.