Levodopa / Carbidopa / Entacapone Orion

What is Levodopa / Carbidopa / Entacapone Orion?

Levodopa / Carbidopa / Entacapone Orion is a medicine containing three active substances: levodopa, carbidopa and entacapone. It is available in a range of tablets in six formulations containing 50 to 200 mg of levodopa and 12.5 to 50 mg of carbidopa. All tablets contain 200 mg of entacapone.
This medicine is the same as Stalevo, which is already authorized in the European Union (EU). The company that makes Stalevo has agreed that its scientific data can be used for Levodopa / Carbidopa / Entacapone Orion ("informed consent").

What is Levodopa / Carbidopa / Entacapone Orion used for?

Levodopa / Carbidopa / Entacapone Orion is indicated for the treatment of adults with Parkinson's disease. Parkinson's disease is a progressive mental disorder that causes tremor, slow movement, and muscle stiffness. Levodopa / Carbidopa / Entacapone Orion is used in patients being treated with levodopa and a dopa decarboxylase inhibitor (two standard treatments for Parkinson's disease) who have "fluctuations" towards the end of the " time between the administration of two doses. Fluctuations occur when the effects of the drug are reduced resulting in the return of symptoms. The fluctuations are related to a reduction in the effects of levodopa, whereby the patient undergoes sudden changes between states ", in which you are able to move, and the" off "state, in which you have difficulty in moving. Levodopa / Carbidopa / Entacapone Orion is used when it is not possible to cure these fluctuations with the standard combination alone. The medicine can only be obtained. with medical prescription.

How is Levodopa / Carbidopa / Entacapone Orion used?

Each Levodopa / Carbidopa / Entacapone Orion tablet contains a full dose of levodopa, in six formulations, with corresponding amounts of carbidopa and entacapone to enhance its efficacy. The formulation of Levodopa / Carbidopa / Entacapone Orion that the patient should take depends on the amount of levodopa needed to control symptoms Further information on how to switch to Levodopa / Carbidopa / Entacapone Orion therapy and how to adjust the dose correctly during treatment can be found in the Summary of Product Characteristics (also part of the EPAR).
The maximum dose of Levodopa / Carbidopa / Entacapone Orion is 10 tablets per day, except for tablets which contain 200 mg of levodopa and 50 mg of carbidopa, in which case the maximum dose is seven tablets per day. Levodopa / Carbidopa / Entacapone Orion tablets should be administered whole and can be taken with or without food. The medicine should be used with caution in patients with mild to moderate liver problems or severe kidney problems.It must also not be used in patients with severe liver problems.

How does Levodopa / Carbidopa / Entacapone Orion work?

In patients with Parkinson's disease, the brain cells that produce the neurotransmitter dopamine begin to die, resulting in a decrease in the concentration of this substance in the brain. Patients therefore lose the ability to reliably control their movements. All the active ingredients present in Levodopa / Carbidopa / Entacapone Orion help restore dopamine levels in the areas of the brain responsible for controlling movement and coordination.
Levodopa turns into dopamine in the brain. Carbidopa and entacapone block some of the enzymes involved in the breakdown of levodopa in the body: carbidopa blocks the dopa decarboxylase enzyme, while entacapone blocks the enzyme catechol-O-methyltransferase (COMT). Consequently, levodopa remains active longer, contributing to improve the symptoms of Parkinson's disease, such as muscle stiffness and slowness of movement. Entacapone has been authorized in the European Union (EU) under the name Comtess / Comtan since 1998. The use of combinations of levodopa and carbidopa is now well established and it is traced back to the mid-1970s. By combining all three active ingredients in a single tablet, the number of tablets to be taken decreases, which can help patients stick to the regimen.

How has Levodopa / Carbidopa / Entacapone Orion been studied?

The company used some data from Comtess / Comtan to support the use of Levodopa / Carbidopa / Entacapone Orion and presented data from the published literature on levodopa and carbidopa.
The company also carried out "bioequivalence" studies to show that taking Levodopa / Carbidopa / Entacapone Orion produces the same concentrations of levodopa, carbidopa and entacapone in the blood as taking separate tablets containing entacapone and a combination of levodopa and carbidopa.

What benefit has Levodopa / Carbidopa / Entacapone Orion shown during the studies?

Studies have shown that Levodopa / Carbidopa / Entacapone Orion is bioequivalent to the separate tablets.

What are the risks associated with Levodopa / Carbidopa / Entacapone Orion?

The most common side effects with Levodopa / Carbidopa / Entacapone Orion (seen in more than 1 in 10 patients) are dyskinesia (involuntary movements), aggravated parkinsonism (worsening of Parkinson's disease), nausea and harmless discoloration of the urine. For the full list of side effects reported with Levodopa / Carbidopa / Entacapone Orion, see the package leaflet.
Levodopa / Carbidopa / Entacapone Orion must not be used in people who may be hypersensitive (allergic) to levodopa, carbidopa, entacapone or any of the other ingredients. Levodopa / Carbidopa / Entacapone Orion must not be given to patients:

• suffering from severe liver disease;
• suffering from narrow-angle glaucoma (increased intraocular pressure);
• suffering from pheochromocytoma (a tumor of the adrenal gland);
• with a "history of neuroleptic malignant syndrome (a serious nerve disorder usually caused by antipsychotic drugs) or rhabdomyolysis (breakdown of muscle fibers).

Levodopa / Carbidopa / Entacapone Orion must not be used simultaneously with other medicines belonging to the group of 'monoamine oxidase inhibitors' (a type of antidepressant). See the Summary of Product Characteristics (also part of the EPAR) for more details.

Why has Levodopa / Carbidopa / Entacapone Orion been approved?

The CHMP decided that Levodopa / Carbidopa / Entacapone Orion's benefits are greater than its risks and recommended that it be given a Marketing Authorization for the medicine.

More information about Levodopa / Carbidopa / Entacapone Orion

On 24 August 2011, the European Commission issued a "Marketing Authorization" for Levodopa / Carbidopa / Entacapone Orion, valid throughout the European Union.
For more information on Levodopa / Carbidopa / Entacapone Orion therapy, read the package leaflet (included in the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 07-2011.

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