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This section provides crucial safety information regarding the use of this medication. Please read the following warnings carefully and discuss any concerns with your healthcare provider.

• Sudden Sleep Onset: Ongentys (opicapone) may cause you to suddenly fall asleep during daily tasks, such as driving. Individuals with a history of sleep disorders or those taking sleep-inducing medications (like opioids, benzodiazepines) or consuming alcohol are at a higher risk. Avoid driving and engaging in activities that require full concentration until you know how this medication affects you. If you experience excessive daytime sleepiness or fall asleep unexpectedly, inform your healthcare provider immediately.

• Low Blood Pressure and Fainting: This medication can lower blood pressure, particularly when standing from a sitting or lying position, leading to dizziness or fainting. To minimize this risk, rise slowly and support yourself when standing. Seek medical attention if you experience symptoms like faintness, lightheadedness, or dizziness, or if you fall and hit your head.

• Involuntary Movements: Ongentys (opicapone) may cause or exacerbate involuntary movements (dyskinesia) due to increased levodopa and altered dopamine levels. This is a common side effect. If you experience uncontrollable movements, contact your healthcare provider, who may adjust your carbidopa/levodopa dosage or other dopamine-raising medications.

• Hallucinations and Behavioral Changes: Rarely, Ongentys (opicapone) can lead to hallucinations or changes in behavior or thinking, such as delusions or aggression. Inform your provider if you have a history of mental health issues, as this medication may not be suitable for you. Mental health medications might also reduce dopamine effects, diminishing Ongentys effectiveness. Report any unusual behaviors to your provider, as discontinuation might be necessary.

• Impulse Control Issues: Increased dopamine levels from Ongentys (opicapone) can lead to impulse control problems, such as compulsive gambling, sexual urges, spending, or binge eating. These issues might be hard to recognize as abnormal. If you or your loved ones notice these urges impacting your life negatively, contact your provider immediately.

Contraindications: Ongentys (opicapone) should not be used in combination with MAO inhibitors or by individuals with conditions that cause high dopamine levels, such as pheochromocytoma. If these apply to you, consult your healthcare provider before starting this medication.

When taking this medication, some common side effects may include unwanted or involuntary movements, constipation, dizziness, drowsiness, and weight loss. These effects are generally mild, but if they persist or worsen, it's important to consult your healthcare provider. To help prevent dizziness or lightheadedness, try to rise slowly from sitting or lying positions.

A few people might experience an increase in sleepiness, and in rare cases, could fall asleep suddenly during daily activities without prior drowsiness. This risk can be heightened by alcohol or other drowsy-inducing medications. If this happens, it's crucial to avoid driving or engaging in potentially dangerous activities until you discuss these effects with your healthcare provider.

There are more serious side effects that need immediate medical attention. These include a fast or irregular heartbeat, mental and mood changes like agitation, confusion, or hallucinations, and unusual strong urges such as increased gambling or binge eating. Additionally, a rare but serious allergic reaction may occur, characterized by rash, severe dizziness, or difficulty breathing.

It's also noteworthy that stopping the medication suddenly can cause symptoms like fever, muscle stiffness, and confusion. If you encounter any side effects not listed, or if you experience any severe reactions, seek medical advice promptly.

It's important to be aware that taking MAO inhibitors alongside this medication can lead to a severe, potentially life-threatening interaction. You should avoid using MAO inhibitors like isocarboxazid, linezolid, metaxalone, methylene blue, moclobemide, phenelzine, procarbazine, and tranylcypromine while on this medication. Furthermore, most MAO inhibitors should not be used for at least two weeks before starting treatment with this medication. However, some MAO inhibitors such as rasagiline, safinamide, and selegiline may be taken under close supervision by your doctor.

Additionally, inform your doctor or pharmacist if you are taking any other substances that can cause drowsiness. This includes opioid pain or cough relievers (e.g., codeine, hydrocodone), alcohol, marijuana (cannabis), medications for sleep or anxiety (e.g., alprazolam, lorazepam, zolpidem), muscle relaxants (e.g., carisoprodol, cyclobenzaprine), or antihistamines (e.g., cetirizine, diphenhydramine). Be sure to check the labels of all your medications, including those for allergies or cough-and-cold, as they may contain ingredients that induce drowsiness. Consult your pharmacist to ensure safe use of these products.