Tolcapone (patient information)

IMPORTANT WARNING:

Tolcapone may cause life threatening liver damage. Tell your doctor if you have or have ever had liver disease. Keep all appointments with your doctor and the laboratory. Your doctor will order certain laboratory tests before and during treatment to check your response to tolcapone.

If you experience any of the following symptoms, call your doctor immediately: upset stomach that does not go away, extreme tiredness, lack of energy, yellowing of the skin or whites of eyes, tenderness on the right upper side of the stomach, itching, loss of appetite, pale stools, or dark urine.

Why is this medication prescribed

Tolcapone is used in combination with levodopa and carbidopa to treat the signs and symptoms of Parkinson's disease.

This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

How should this medicine be used

Tolcapone comes as a tablet to take by mouth. It is usually taken three times a day. Your doctor will most likely prescribe this in addition to levodopa and carbidopa (Sinemet). Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take tolcapone exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Tolcapone controls symptoms of Parkinson's disease but does not cure it. Continue to take tolcapone even if you feel well. Do not stop taking tolcapone without talking to your doctor. Abrupt discontinuation of tolcapone may cause high fever and confusion.

What special precautions should I follow

Before taking tolcapone

• tell your doctor and pharmacist if you are allergic to tolcapone or any other drugs.
• tell your doctor and pharmacist what prescription and nonprescription medications you are taking, especially anticoagulants (blood thinners) such as warfarin (Coumadin), desipramine (Norpramin), dobutamine (Dobutrex), drugs that cause drowsiness (sedatives, tranquilizers, and sleeping pills), isoproterenol (Isuprel), MAO inhibitors [phenelzine (Nardil) or tranylcypromine (Parnate)], methyldopa (Aldomet), and vitamins.
• in addition to the condition listed in the IMPORTANT WARNING section, tell your doctor if you have or have ever had heart or kidney disease or rhabdomyolysis (skeletal muscle disease).
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking tolcapone, call your doctor.
• if you are having surgery, including dental surgery, tell your doctor or dentist that you are taking tolcapone.
• you should know that this drug may make you drowsy. Do not drive a car or operate machinery until you know how tolcapone will affect you.
• remember that alcohol can add to the drowsiness caused by this drug.

What special dietary instructions should I follow

Tolcapone may cause an upset stomach. Tolcapone may be taken with food to reduce nausea.

What should I do if I forget a dose

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Side Effects

Minor Side Effects

Tolcapone may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• sleep disturbances
• excessive dreaming
• diarrhea
• dizziness
• vomiting
• increased sweating

Severe Side Effects

If you experience any of the following symptoms, or any of those listed in the IMPORTANT WARNING section, call your doctor immediately:

• hallucinations
• confusion
• irregular heartbeat

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/report.htm] or by phone [1-800-332-1088].

What storage conditions are needed for this medicine

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What other information should I know

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Brand names

• Tasmar®