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What is Stalevo? Stalevo is a medicine containing three active substances: levodopa, carbidopa and entacapone (levodopa, carbidopa and entacapone). It is available in the form of different types of tablets in seven concentrations containing 50 to 200 mg levodopa and 12.5 to 50 mg carbidopa. All contain 200 mg entacapone. What is Stalevo used for? Stalevo is used to treat patients with Parkinson's disease. Parkinson's disease is a progressive brain disorder that causes shaking, slowing movements and stiffness of the muscles. Stalevo is used in patients treated with a combination of levodopa and a dopa decarboxylase inhibitor (two standard treatments for Parkinson's disease) but who have "fluctuations" at the end of the period between the two doses of the medicines. Fluctuations occur when the action of the drug is weakened and the symptoms return. These are related to the reduction of the effects of levodopa, in which the patient experiences a sharp transition from a good state of affairs and the ability to move to a sudden deterioration of the condition and difficulty in movement. Stalevo is used when these fluctuations can not be treated with the standard combination alone. Medicinal product subject to medical prescription. European Medicines Agency, 2010. Reproduction is authorized provided the source is acknowledged. How is Stalevo used? Each Stalevo tablet contains one full dose of levodopa in seven concentrations with the appropriate amounts of carbidopa and entacapone to improve the effectiveness. The Stalevo concentration that patients should use is based on the amount of levodopa needed to control the symptoms. For full instructions on how patients should be switched to Stalevo and how to adjust the dose during treatment - see the Summary of Product Characteristics (also part of the EPAR). The maximum daily dose of Stalevo is 10 tablets, except for tablets containing 200 mg levodopa and 50 mg carbidopa, where the maximum daily dose is seven tablets. Stalevo tablets should be taken with or without food. Tablets should be used with caution in patients with mild to moderate liver problems or serious kidney problems. Tablets should not be used in patients with severe liver problems. How does Stalevo work? In patients with Parkinson's disease brain cells that produce the neurotransmitter dopamine begin to die and the amount of dopamine in the brain decreases. As a result, patients lose the ability to control their movements reliably. All active substances in Stalevo work to restore dopamine levels in brain regions, controlling movement and coordination.
In the brain, levodopa is converted to dopamine. Both carbidopa and entacapone block some of the enzymes involved in degrading levodopa in the body: carbidopa blocks the dopa-decarboxylase enzyme and entacapone blocks the catechol-O-methyltransferase enzyme (COMT). As a result, levodopa is active for a longer period. This helps to improve the symptoms of Parkinson's disease, such as stiffness and slow motoring. Entacapone has been approved in the European Union (EU) under the name Comtess / Comtan since 1998. The use of combinations of levodopa and carbidopa is well known since these combinations have been used since the mid-1970s. The collection of all these substances in one tablet can reduce the number of tablets patients have to take and help patients adhere to treatment. How has Stalevo been studied? The company uses some of Comtess / Comtan data to support the use of Stalevo and provides data from published literature on levodopa and carbidopa. The company conducted bioequivalence studies to show that Stalevo intake resulted in the same serum levels of levodopa, carbidopa and entacapone as with the use of separate tablets containing entacapone and a combination of levodopa and carbidopa. What benefit has Stalevo shown during the studies? Studies have shown that Stalevo is bioequivalent to the individual tablets.
What is the risk associated with Stalevo? The most common side effects with Stalevo (seen in more than 1 patient in 10) are dyskinesia (uncontrollable movements), poor parkinsonism (nausea), nausea (feeling sick) and innocuous urine coloring. For the full list of all side effects reported with Stalevo, see the Package Leaflet. Stalevo should not be used in people who may be hypersensitive (allergic) to levodopa, carbidopa, entacapone or any of the other ingredients. Stalevo should not be used in patients with: severe liver disease; narrow-angle glaucoma (increased eye pressure); pheochromocytoma (adrenocortical tumor); a history of malignant neuroleptic syndrome (severe neural disorder usually caused by antipsychotic medications), or rhabdomyolysis
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