Important safety information:
You must discuss the benefits and risks of tolcapone with your doctor and sign a patient acknowledgment form before you begin treatment with tolcapone.
Tolcapone may cause drowsiness, dizziness, or light-headedness. These effects may be worse if you take it with alcohol or certain medicines. Use tolcapone with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using tolcapone; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
Tolcapone may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
Some patients who take tolcapone have reported suddenly falling asleep while performing daily activities (eg, driving, eating, talking). Some patients did not experience drowsiness and felt that they were alert immediately before suddenly falling asleep. Some of these events have been reported as late as 1 year after tolcapone was started. Use caution when driving, operating machinery, or performing other activities that could be dangerous. Inform your doctor if you experience unusual drowsiness or sleepiness while using tolcapone.
If your symptoms do not get better within 3 weeks or if they get worse, check with your doctor.
Some patients who take tolcapone may develop certain muscle movements that they cannot control. Tell your doctor at once if you have new or worsening muscle problems with your arms, legs, or your face, mouth, or jaw (eg, tongue sticking out, puffing of cheeks, mouth puckering, chewing movements) while you take tolcapone.
Tolcapone may cause nausea or diarrhea. Nausea may be more likely when you first start taking tolcapone. If nausea or diarrhea occurs, discuss with your doctor ways to lessen the effects.
Some people have experienced new, unusual, or increased urges (eg, gambling, sexual urges) while using tolcapone. Tell your doctor right away if you notice such effects.
Patients with Parkinson disease may have an increased risk of developing a certain type of skin cancer (melanoma). It is not known if tolcapone also increases the risk of melanoma. You may need to have skin exams while you are using tolcapone. Tell your doctor if you notice any unusual skin growths or a change in the appearance of a mole. Discuss any questions or concerns with your doctor.
Use tolcapone with caution in the ELDERLY; they may be more sensitive to its effects, especially hallucinations.
Lab tests, including liver function tests, may be performed while you use tolcapone. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
Tolcapone is not recommended for use in CHILDREN; safety and effectiveness in children have not been confirmed.
PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using tolcapone while you are pregnant. It is not known if this medicine is found in breast milk. If you are or will be breast-feeding while you use tolcapone, check with your doctor. Discuss any possible risks to your baby.