Oprymea 1.1 mg tablets

ATC Code
N04BC05
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About this drug

Admission country
Manufacturer Krka, D.D., Novo Mesto
Narcotic drug No
Psychotropic No
Anatomical group Nervensystem
Therapeutic group Antiparkinsonmittel
Pharmacological group Dopaminerge mittel
Chemical group Dopaminrezeptoragonisten
Substance Pramipexol

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All to know

Author

Krka, D.D., Novo Mesto

What is it?

Oprymea is a medicine containing 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 means that Oprymea is similar to a ?reference medicine? already authorised in the European Union (EU) called Sifrol (also known as Mirapexin). For more information on generic medicines, see the question-and-answer document here.

What is it 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.

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How is it used?

Oprymea tablets should be swallowed with water, with or without food. The starting dose is 0.088 mg three times per 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 1.1 mg three times per day. Oprymea must be given less frequently in patients who have problems with their kidneys. If treatment is stopped for any reason, the dose should be decreased gradually. For more information, see the Package Leaflet.

How does it 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 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.

How has it been studied?

Because Oprymea is a generic medicine, studies have been limited to tests to demonstrate that it is bioequivalent to the reference medicine (they produce the same levels of the active substance in the body).

What benefits has it shown during the studies?

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

What is the risk associated?

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

Why has it been approved?

The Committee for Medicinal Products for Human Use (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.

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