Tolcapone

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.

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.

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.

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, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking tolcapone. Your doctor may need to change the doses of your medications or monitor you carefully for side effects..
• 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.

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

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.

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

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).

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

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.

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

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

• Tasmar^®