In the U.S.—

• Antidyskinetic (COMT inhibitor)

Tolcapone (TOLE-ka-pone) is used in combination with levodopa and carbidopa for the treatment of the symptoms of Parkinson's disease.

This medicine is available only with your doctor's prescription, in the following dosage form(s):

Oral
• Tablets (U.S.)

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For tolcapone, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to tolcapone. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Tolcapone has not been studied in pregnant women. However, studies in animals have shown that tolcapone causes birth defects and other problems. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—It is not known whether tolcapone passes into breast milk. However, because of the risk of unwanted effects in nursing babies, make sure your doctor knows if you are breast-feeding or planning to breast-feed.

Children—Studies on this medicine have been done only in adult patients. There is no identified potential use of tolcapone in children.

Older adults—The risk of hallucinations (seeing, hearing, or feeling things that are not there) may be increased in patients older than 75 years of age.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your doctor and pharmacist if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

• Hallucinations (seeing, hearing, or feeling things that are not there)—Condition may become worse

• Kidney problems, severe—Elimination of tolcapone may be decreased, which increases the risk of unwanted effects

• Liver problems—Chance of serious unwanted effects may be increased

• Low blood pressure or
• Orthostatic or postural low blood pressure (dizziness or lightheadedness when getting up suddenly from a sitting or lying position)—Condition may become worse

Take this medicine only as directed by your doctor, to help your condition as much as possible. Do not take more or less of it, and do not take it more or less often than your doctor ordered.

Dosing—

The dose of tolcapone will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of tolcapone. If your dose is different, do not change it unless your doctor tells you to do so.

The number of tablets that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on your medical condition.

• For oral dosage form (tablets):
  • For Parkinson's disease:
    • Adults—100 milligrams (mg) three times a day, taken in addition to levodopa and carbidopa.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Keep the medicine from freezing. Do not refrigerate.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

It is important that your doctor check your progress at regular visits. Tolcapone may have serious effects on your liver. You must have regular blood tests done to make sure this medicine is not affecting your liver.

Because tolcapone may have serious effects on your liver, you should watch for any signs of these effects. Signs include dark urine; itching; light-colored stools; loss of appetite; nausea (continuing); tenderness in upper right part of abdomen; unusual drowsiness, dullness, or feeling sluggish; unusual tiredness or weakness; or yellow eyes or skin. If you notice any of these signs, contact your doctor.

Do not stop taking tolcapone without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping completely.

Tolcapone may cause dizziness or lightheadedness, drowsiness, weakness, or trouble in thinking or concentrating. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert, well-coordinated, or able to think clearly.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. Getting up slowly may help. If you should have this problem, check with your doctor.

Hallucinations (seeing, hearing, or feeling things that are not there) may occur in some patients. This is more common in elderly patients.

Tolcapone causes the urine to turn bright yellow. This is to be expected while you are taking it. This effect is harmless and will go away after you stop taking the medicine.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Rare
  • Dark urine;  itching;  light-colored stools;  loss of appetite;  nausea (continuing);  tenderness in upper right part of abdomen;  unusual drowsiness, dullness, or feeling sluggish;  unusual tiredness or weakness ;  yellow eyes or skin 
  
  

Check with your doctor as soon as possible if any of the following side effects occur:

• More common
  • Abdominal pain;  cough;  diarrhea;  dizziness;  dizziness or lightheadedness when getting up from a lying or sitting position ;  drowsiness;  fainting;  fever;  hallucinations (seeing, hearing, or feeling things that are not there);  headache;  nasal congestion (stuffy nose);  nausea ;  runny nose;  sneezing;  sore throat;  trouble in sleeping;  twitching, twisting, or other unusual body movements;  vomiting 
  
  

• Less common
  • Blood in urine;  chest pain;  chills;  confusion;  falling;  general feeling of discomfort or illness ;  hyperactivity;  loss of balance control;  muscle pain;  troubled breathing 
  
  

• Rare
  • Agitation;  bloody or cloudy urine;  burning of feet;  burning, prickling, or tingling sensations;  chest discomfort;  difficult or painful urination;  difficulty in thinking or concentrating;  frequent urge to urinate ;  irritability;  joint pain, redness, or swelling;  low blood pressure;  muscle cramps;  neck pain;  stiffness 
  
  

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

• More common
  • Constipation;  dryness of mouth;  excessive dreaming;  increased sweating  
  
  

• Less common
  • Heartburn;  gas 
  
  

After you stop using this medicine, your body may need time to adjust. The length of time this takes depends on the amount of medicine you were using and how long you used it. During this period of time, check with your doctor if you notice that the following side effects occur together:

• Confusion;  fever;  muscle rigidity 

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.