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The following information outlines critical safety and warning guidelines regarding the use of Rytary (carbidopa/levodopa). It is essential to understand these risks and consult with your healthcare provider if you have any concerns or questions.

• Sudden Sleepiness: There have been reports of individuals falling asleep unexpectedly while using medications containing levodopa, such as Rytary. This can occur without prior feelings of drowsiness and has been known to result in incidents during activities like driving. Increased risk is present for those with a history of drowsiness, sleep disorders, or who are taking sedatives.

• Withdrawal Symptoms: Abruptly stopping or reducing the dose of Rytary may lead to symptoms resembling neuroleptic malignant syndrome, characterized by high fevers, confusion, muscle stiffness, irregular pulse, breathing changes, and blood pressure fluctuations.

• Cardiac Concerns: Some users have experienced heart-related issues while on Rytary, particularly those with a history of heart disease or risk factors such as hypertension or high cholesterol. It is important to discuss any pre-existing heart conditions with your doctor.

• Psychiatric Effects: Rytary may increase the risk of hallucinations, confusion, sleep disturbances, and vivid dreams, especially shortly after starting the medication. These symptoms may subside with a reduced dosage. Notify your healthcare provider if you or someone close to you notices any of these effects.

• Impulsive Behaviors: The medication may lead to increased impulsivity, resulting in urges such as excessive gambling, spending, sexual activities, or overeating. Monitoring and managing these behaviors are important.

• Gastrointestinal Bleeding: There is a heightened risk for stomach bleeding in individuals with a history of stomach ulcers. Seek immediate medical attention if you experience vomiting of blood, dark stools, or severe abdominal pain.

• Eye Pressure Increase: For patients with glaucoma, Rytary may elevate intraocular pressure. Regular eye exams and pressure monitoring are advised to prevent any worsening of the condition.

Contraindications:

• Do not use Rytary if you are currently taking or have taken nonselective monoamine oxidase inhibitors (MAOIs) in the past two weeks, as this may pose serious health risks.

Please ensure these guidelines are discussed with your healthcare provider to ensure safe and effective use of this medication.

When taking this medication, some common side effects may include dizziness, nausea, headache, trouble sleeping, dry mouth, unusual dreams, constipation, involuntary movements, anxiety, vomiting, and a drop in blood pressure upon standing. These effects are generally mild, but consult your healthcare provider if they persist or worsen.

More concerning side effects, although less common, require immediate medical attention. These include severe allergic reactions such as skin rash, itching, hives, and swelling of the face, lips, tongue, or throat. There is also a risk of falling asleep suddenly during daily activities, heart rhythm changes, and significant mood and behavior changes like anxiety, confusion, hallucinations, irritability, hostility, or thoughts of self-harm. If you experience any new or worsening uncontrolled movements or impulsive behaviors, seek medical advice promptly.

Serious heart problems can occur, such as chest pain, shortness of breath, or cold sweats. Sudden changes in vision, like blurry vision or seeing halos, and stomach bleeding characterized by bloody or tar-like stools should also be addressed urgently. In rare cases, suddenly stopping the medication may lead to withdrawal symptoms, including confusion, high fever, muscle stiffness, and changes in breathing and pulse. Always ensure to discuss any concerning symptoms with your healthcare provider.