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Active Substance: pramipexole dihydrochloride monohydrate
Common Name: pramipexole
ATC Code: N04BC05
Marketing Authorisation Holder: Krka, d.d., Novo mesto
Active Substance: pramipexole dihydrochloride monohydrate
Status: Authorised
Authorisation Date: 2008-09-12
Therapeutic Area: Parkinson Disease
Pharmacotherapeutic Group: Anti-Parkinson drugs

Therapeutic Indication

Oprymea is indicated 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 Oprymea?

Oprymea is a medicine containing the active substance pramipexole. It is available as immediate-release tablets (0.088 mg, 0.18 mg, 0.35 mg, 0.7 mg and 1.1 mg) and prolonged-release tablets (0.26 mg, 0.52 mg, 1.05 mg, 1.57 mg, 2.1 mg, 2.62 mg and 3.15 mg). Immediate–release tablets release the active substance immediately, and prolonged-release tablets release it slowly over a few hours.

Oprymea is a ‘generic medicine’. This means that Oprymea is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Sifrol (also known as Mirapexin). 

What is Oprymea used for?

Oprymea is used to treat the symptoms of Parkinson’s disease, a progressive brain disorder that causes shaking, slow movement and muscle stiffness. Oprymea 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.

The medicine can only be obtained with a prescription.

How is Oprymea used?

The starting dose is either one 0.088-mg immediate-release tablet three times per day or one 0.26-mg prolonged-release tablet once 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 for the immediate-release tablets is 1.1 mg three times per day and in case of the prolonged release tablets is 3.15 mg once a day. Oprymea must be given less frequently in patients who have problems with their kidneys. If treatment needs to be stopped for any reason, 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, which imitates the action of dopamine. Dopamine is a messenger substance in the parts of the brain that control movement and coordination. 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.

How has Oprymea been studied?

Because Oprymea is a generic medicine, studies in people have been limited to tests to demonstrate that it is bioequivalent to the reference medicine, Sifrol. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.

What are the benefits and risks of Oprymea?

Because Oprymea is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as the reference medicine’s.

Why has Oprymea been approved?

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

What measures are being taken to ensure the safe and effective use of Oprymea?

A risk management plan has been developed to ensure that Oprymea is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Oprymea, including the appropriate precautions to be followed by healthcare professionals and patients.

Other information about Oprymea

The European Commission granted a marketing authorisation valid throughout the EU for Oprymea on 12 September 2008.

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

Source: European Medicines Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.