What is Numient and what is it used for?
Numient is indicated for the treatment of symptoms of Parkinson's disease, a progressive mental disorder that causes tremor, slow movement and muscle stiffness. Contains the active ingredients levodopa and carbidopa.
How is Numient used - Levodopa / Carbidopa?
Numient is available as capsules to be taken by mouth. The starting dose for patients who have never taken levodopa before is one capsule containing 95 mg of levodopa and 23.75 mg of carbidopa, three times a day for the first three days. The doctor may subsequently increase the dose depending on the patient's response to treatment. In patients already taking levodopa, the doctor determines the dose of Numient based on the current therapy.
Numient capsules are taken with a glass of water, with or without food, but not at the same time as a high protein meal, which may reduce the absorption of the medicine.
Patients who have difficulty swallowing the capsule can spread the contents on soft foods such as apple puree, yogurt or pudding. Food must therefore be ingested immediately, without chewing.
Numient can only be obtained with a prescription and is available in the following strengths: 95 mg / 23.75 mg, 145 mg / 36.25 mg, 195 mg / 48.75 mg and 245 mg / 61.25 mg. For more information on the use of Numient, see the Summary of Product Characteristics (also part of the EPAR).
How does Numient work - Levodopa / Carbidopa?
In patients with Parkinson's disease, the brain cells that produce dopamine, a neurotransmitter important in controlling movement, begin to die and the amount of dopamine in the brain decreases.
Numient contains levodopa, which turns into dopamine in the brain, helping to restore dopamine levels. The carbidopa substance present in Numient prevents levodopa from turning into dopamine in the general bloodstream, i.e. before it reaches the brain. The combination of levodopa and carbidopa is used in other medicines used to treat Parkinson's disease.
In Numient, some of the active ingredients are released immediately, while the remainder is released gradually, allowing for more stable levels of levodopa. Capsules of this type are known as modified release capsules.
What benefit has Numient - Levodopa / Carbidopa shown during the studies?
In a study involving 381 patients with early Parkinson's disease, Numient given at various doses was more effective in improving symptoms than placebo (a dummy treatment). After 30 weeks, Numient-treated patients experienced an average improvement of 11.7 to 14.9 points (depending on dose) on a standard symptom scale (UPDRS, Unified Parkinson's Disease Rating Scale, part II and part III) In subjects treated with placebo, the mean improvement was 0.6 points.
A second study compared Numient with another levodopa and carbidopa treatment in 393 patients with advanced Parkinson's disease. The study looked at the extent to which treatments helped reduce so-called "off" periods, in which patients have more difficulty walking. After 13 weeks, Numient-treated patients reported "off" periods of 24% awake hours compared with 30% awake hours reported by comparator-treated patients. In both groups, the "off" phase at the start of the study corresponded to 36-37% of the waking hours.
What is the risk associated with Numient - Levodopa / Carbidopa?
The most common side effects with Numient are nausea (affecting 12% of patients), dizziness, headache and involuntary movements (each seen in 8% of patients) and insomnia (6% of patients). frequency uncommon, including bleeding in the intestine and allergic reactions.
Numient must not be used in patients with narrow-angle glaucoma (an eye disorder) or pheochromocytoma (a tumor of the adrenal glands). It must also not be used in patients taking medicines known as non-selective monoamine oxidase (MAO) inhibitors or in patients who have suffered from certain conditions in the past. For the full list of side effects and limitations, see the package leaflet.
Why has Numient - Levodopa / Carbidopa been approved?
Studies show that Numient is effective in reducing symptoms in patients with early and advanced Parkinson's disease. Another benefit concerns the formulation of the active ingredients in Numient, which favors the maintenance of more stable levels of levodopa.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that Numient's benefits are greater than its risks and recommended that it be approved for use in the EU.
What measures are being taken to ensure the safe and effective use of Numient - Levodopa / Carbidopa?
A risk management plan has been developed to ensure that Numient is used as safely as possible. Based on this plan, safety information has been added to the summary of product characteristics and package leaflet for Numient, including the appropriate precautions to be followed by healthcare professionals and patients.
More information about Numient - Levodopa / Carbidopa
For more information about Numient therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.
The information on Numient - Levodopa / Carbidopa published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
