TOLCAPONE (Systemic)

Some commonly used brand names are:

In the U.S.?

• Tasmar

Category

• Antidyskinetic (COMT inhibitor)

Description

Tolcapone (TOLE-ka-pone) is used in combinationwith levodopa and carbidopa for the treatment of the symptoms of Parkinson'sdisease.

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

Oral
• Tablets (U.S.)

Before Using This Medicine

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

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

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

Breast-feeding?It is not known whether tolcapone passes into breastmilk. 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 adultpatients. There is no identified potential use of tolcapone in children.

Older adults?The risk of hallucinations (seeing, hearing, or feelingthings that are not there) may be increased in patients older than 75 yearsof age.

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

Other medical problems?The presence of other medicalproblems may affect the use of tolcapone. Make sure you tell your doctor ifyou have any other medical problems, especially:

• Hallucinations (seeing, hearing, or feeling things that are not there)?Conditionmay become worse

• High fever and confusion or
• Muscle injury, aches, cramps?You should not take tolcapone.

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

• Liver problems or
• Liver tests higher than normal?This medicine can increase chancesof serious liver problems. You should not start taking this medicine if youhave these problems.

• Low blood pressure or
• Orthostatic or postural low blood pressure (dizziness or lightheadednesswhen getting up suddenly from a sitting or lying position)?Conditionmay become worse

Proper Use of This Medicine

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

It is important that you and your doctor discuss the risks of this medicineand that you read and sign a written informed consent before you begin takingthis medicine.

Dosing?The dose of tolcapone will be different fordifferent patients. Follow your doctor's orders or thedirections on the label. The following information includes only theaverage 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 timeallowed between doses, and the length of time you take the medicine dependon your medical condition.

• For oral dosage form (tablets):
  • For Parkinson's disease:
    • Adults?100 milligrams (mg) three times a day, taken in additionto 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 assoon as possible. However, if it is almost time for your next dose, skip themissed 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 otherdamp 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 surethat any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

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

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

Do not stop taking tolcapone without first checkingwith your doctor. Your doctor may want you to gradually reduce theamount you are taking before stopping completely.

Tolcapone may cause dizziness or lightheadedness, drowsiness, weakness,or trouble in thinking or concentrating. Make sure youknow how you react to this medicine before you drive, use machines, or doanything 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 slowlymay help. If you should have this problem, check with your doctor.

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

You may experience nausea, especially when you first begin taking thismedicine.

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

Side Effects of This Medicine

Along with its needed effects, a medicine maycause 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 anyof the following side effects occur:

Incidence not known

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

Check with your doctor assoon 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

Absence of or decrease in body movement; blood in urine; chest pain; chills; confusion; falling; general feeling of discomfort or illness; hyperactivity; loss of balance control; muscle pain; troubledbreathing

Rare

Agitation; bloody or cloudy urine; burning of feet; burning, prickling,or tingling sensations; chest discomfort; difficult or painful urination; difficultyin 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 donot need medical attention. These side effects may go away during treatmentas your body adjusts to the medicine. However, check with your doctor if anyof the following side effects continue or are bothersome:

More common

Constipation; dryness of mouth; excessive dreaming; increased sweating

Less common

Bleeding; difficulty in sleeping; excessive muscle tone; fever; heartburn; gas; muscle stiffness; muscle tension or tightness; trouble in holding or releasing urine

After you stop using thismedicine, your body may need time to adjust. The length of time this takesdepends 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 thefollowing side effects occur together:

Confusion; fever; muscle rigidity

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