Rarely, tolcapone has caused a severe (sometimes fatal) liver problem (liver failure). Tolcapone should not be used if you have even mild liver disease. You should only use tolcapone if you are experiencing problems with your levodopa wearing off between doses. If you show no benefit from tolcapone after 3 weeks of using it, your doctor may choose to stop it.
Before and during treatment with tolcapone, you will have certain blood tests (liver function tests) every few weeks to monitor for liver problems. Keep all medical and lab test appointments. Tell your doctor right away if you experience symptoms of liver problems (such as persistent nausea/vomiting, abdominal pain, dark urine, severe tiredness, loss of appetite, itchiness). If you experience liver problems from taking tolcapone, you should not take it again.
Your doctor may ask you to sign a consent form after telling you about the possible side effects of this medication.
This medication is used with other medications (levodopa/carbidopa) to treat Parkinson's disease. Tolcapone belongs to a class of drugs known as COMT inhibitors. Many people taking levodopa for Parkinson's have problems with the effects of the levodopa wearing off between scheduled doses, causing symptoms to return or worsen. Tolcapone blocks a certain natural substance (COMT enzyme) that breaks down levodopa in the body. This effect allows the levodopa to last longer in the system so that it doesn't wear off before the next dose.
Take this medication by mouth with or without food, usually 3 times daily or as directed by your doctor. You will start on a low dose. Your doctor may increase your dosage after 3 weeks if he or she thinks that you will benefit from a higher dose.
Dosage is based on your medical condition and response to therapy.
Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day. Do not suddenly stop taking this medication unless instructed to do so by your doctor. Doing so may cause your Parkinson's symptoms to become much worse.
Tell your doctor if your condition persists or worsens (such as your Parkinson's symptoms are not controlled).
See also Warning section.
Nausea/vomiting, unwanted/uncontrolled movements, diarrhea, headache, drowsiness, trouble sleeping, increased number of dreams, increased sweating, dry mouth, gas, and abdominal pain may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication may develop serious side effects, but with frequent visits to your doctor, this risk can be minimized.
Some people taking tolcapone have fallen asleep suddenly during their usual daily activities (such as talking on the phone, driving). In some cases, sleep occurred without any feelings of drowsiness beforehand. This sleep effect may occur anytime during treatment with tolcapone even if you have used this medication for a long time. If you experience increased sleepiness or fall asleep during the day, do not drive or take part in other possibly dangerous activities until you have discussed this effect with your doctor. Your risk of this sleep effect is increased by using alcohol or other medications that can make you drowsy. See also Precautions section.
Your urine may change color (such as increased yellow color). This effect is harmless.
Tell your doctor right away if you have any serious side effects, including: easy bleeding/bruising, chest pain, fast/irregular heartbeat, fever, mental/mood changes (such as agitation, confusion, hallucinations), unusual strong urges (such as increased gambling, increased sexual urges), muscle pain/soreness/stiffness/weakness, pain/trouble with breathing.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
See also Warning section.
Before taking tolcapone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: alcoholism, low blood pressure, Parkinson's with severe movement problems, liver problems, mental/mood disorders (such as psychosis, schizophrenia), history of a certain muscle problem (rhabdomyolysis), fever and confusion caused by any drug.
This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages. See also Side Effects section.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
Older adults may be more sensitive to the side effects of this drug, especially drowsiness, confusion, and hallucinations.
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.
To help your doctor or pharmacist give you the best care, be sure to tell your doctor or pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.
Other MAO inhibitors (selegiline, rasagiline) may be used cautiously with close monitoring by your doctor. If you are taking rasagiline or selegiline for Parkinson's disease, ask your doctor if you should continue taking it.
Tell your doctor or pharmacist if you are taking other products that cause drowsiness including alcohol, antihistamines (such as cetirizine, diphenhydramine), drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants, and narcotic pain relievers (such as codeine).
This document does not contain all possible interactions. Keep a list of all the products you use. Share this list with your doctor and pharmacist to lessen your risk for serious medication problems.
If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
Laboratory and/or medical tests (such as liver function tests) should be performed before you start tolcapone and periodically during your treatment to monitor your progress or check for side effects. Consult your doctor for more details.
People with Parkinson's disease may have an increased risk for developing skin cancer (melanoma). Tell your doctor promptly if you notice a change in the appearance or size of moles or other unusual skin changes. Ask your doctor if you should have regular skin exams.
If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip themissed dose and resume your usual dosing schedule. Do not double the dose to catch up.
Store at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.Information last revised July 2016. Copyright(c) 2016 First Databank, Inc.
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