Tolcapone

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 medicine 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.

• 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 to take 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.

What SIDE EFFECTS can this medicine cause?

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

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 (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

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).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call 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.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.