When This Medicine Should Not Be Used:
You should not use use this medicine if you have had an allergic reaction to tolcapone.

How to Use This Medicine:
Tablet

• Your doctor will tell you how much medicine to use and how often. This medicine is given with levodopa/carbidopa (Sinemet®), because it helps levodopa work in your body for a longer amount of time. Use all of your medicines exactly as your doctor ordered.
• You may take tolcapone with or without food. If the medicine upsets your stomach, try taking it with food.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are using other medicines that could make you drowsy such as sleeping pills, tranquilizers, some cold and allergy medicines, narcotic pain-killers, or medicines that relax your muscles.
• Tell your doctor if you drink alcohol. You may get too drowsy or sedated if you drink alcohol or use medicines that cause drowsiness with tolcapone.
• Tell your doctor if you are using Coumadin® (warfarin) or desipramine (Norpramin®).
• Make sure your doctor knows if you are using a medicine to treat depression called an MAO inhibitor. Marplan® (isocarboxazid), Nardil® (phenelzine), and Parnate® (tranylcypromine) are MAO inhibitors.

Warnings While Using This Medicine:

• Tolcapone may make you dizzy or sleepy, especially when you first start using the medicine. Avoid driving or using machinery until you know how the medicine affects you.
• Dizziness may be worse if you get up too fast after sitting or lying down. Getting up slowly from a sitting or lying position may help.
• Check with your doctor before using this medicine if you have liver or kidney disease.
• Talk to your doctor before using this medicine if you are pregnant, planning to become pregnant, or breastfeeding.
• This medicine may cause hallucinations (seeing or hearing something that does not exist). If you have questions about this, talk with your doctor.
• Do not suddenly stop using this medicine. You may need to use smaller and smaller doses before completely stopping the medicine.
• You will need to have your blood tested regularly while using tolcapone to make sure it is not causing harmful side effects. Keep all appointments your doctor makes for you.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Increased loss of muscle control
• Fainting
• Yellowing of your skin or eyes
• Severe or bloody diarrhea

If you notice these less serious side effects, talk with your doctor:

• Mild diarrhea
• Hallucinations, confusion, increased dreaming
• Trouble sleeping
• Feeling dizzy, lightheaded, or tired
• Nausea, upset stomach
• Changes in the color of your urine

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088