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The following safety information outlines the potential risks and precautions associated with the use of Sinemet (carbidopa/levodopa). Please review this information carefully and consult your healthcare provider if you have any questions or concerns.

• Drowsiness and Sudden Sleep Episodes: Sinemet may cause unexpected sleepiness or sudden sleep episodes during daily activities. Until you understand how this medication affects you, refrain from operating vehicles or engaging in tasks that require full attention, especially if you have a history of drowsiness or sleep problems. Avoid combining Sinemet with other sedative medications, as this can increase drowsiness. Notify your healthcare provider if you experience excessive daytime sleepiness or fall asleep during activities requiring concentration.

• High Fevers and Confusion: Abruptly stopping or reducing the dose of Sinemet can lead to symptoms similar to neuroleptic malignant syndrome (NMS), a potentially life-threatening condition. Symptoms may include high fever, confusion, irregular heartbeat, sweating, muscle rigidity, and blood pressure changes. Do not discontinue or adjust your dose without consulting your healthcare provider to ensure a safe cessation plan.

• Hallucinations and Behavioral Changes: Sinemet may induce hallucinations or alter behavior and thought processes, potentially leading to paranoia, delusions, confusion, aggression, restlessness, sleep disturbances, vivid dreaming, and decreased situational awareness. These effects generally appear soon after starting treatment and may resolve upon discontinuation or dosage adjustment. Sinemet should not be used in individuals with certain mental health disorders. Some mental health medications, like haloperidol or perphenazine, can exacerbate Parkinson's symptoms and interfere with Sinemet’s efficacy.

• Impulse Control Issues: The medication may lead to impulsive behaviors, such as increased sexual urges, gambling, excessive spending, or binge eating. If these behaviors adversely affect your life, inform your healthcare provider. Since you may not recognize these urges, your provider may inquire about any recent occurrences during follow-up visits.

• Increased Risk of Skin Cancer: Parkinson's disease patients have an elevated risk of developing skin cancer. Regularly monitor your skin for new or unusual growths or changes in moles, and inform your healthcare provider of any concerns. Periodic skin evaluations may be recommended.

Contraindications: Do not use Sinemet if you are taking nonselective monoamine oxidase inhibitors (MAOIs) or if you have narrow-angle glaucoma. Discuss with your healthcare provider if these conditions apply to you before starting the medication.

Common side effects:

• Dizziness
• Lightheadedness
• Nausea
• Vomiting
• Loss of appetite
• Headaches
• Trouble sleeping

Less common but important to monitor:

• Unusual dreams
• Increased sleepiness
• Involuntary movements (dyskinesia or dystonia)
• Mood changes (depression and confusion)

Serious side effects:

• Neuroleptic malignant syndrome (NMS)
• Hallucinations
• Vision changes
• Severe abdominal pain
• Black or tarry stools
• Coffee-ground-like vomit
• Signs of infection (persistent sore throat or easy bruising)
• Very serious allergic reaction (rash, severe dizziness, breathing difficulties)

Interactions with high risk of serious adverse effects and should be avoided:

• MAO inhibitors (isocarboxazid, Linezolid, Metaxalone, methylene blue, moclobemide, phenelzine, procarbazine, Tranylcypromine)

Interactions with moderate risk that may require dose adjustment, closer monitoring, or timing changes:

• MAO inhibitors (Rasagiline, safinamide, Selegiline)