When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to entacapone.

How to Use This Medicine:
Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how entacapone works. Tell your doctor if you are also using alpha-methyldopa, apomorphine, cholestyramine, dobutamine, dopamine, epinephrine, isoetharine, isoproterenol, norepinephrine, probenecid, selegiline, warfarin, an MAO inhibitor (MAOI, such as phenelzine, tranylcypromine), or medicine to treat an infection (such as ampicillin, chloramphenicol, erythromycin, rifampicin).
• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have liver disease, low blood pressure, muscle problems, or a history of mental illness.
• This medicine may cause the following problems:
  
  • Low blood pressure
  • Unusual changes in mood or behavior, compulsive behaviors, hallucinations
  • Possible increased risk for skin cancer
• This medicine may make you dizzy or drowsy. It may even cause you to fall asleep without warning. Do not drive or do anything that could be dangerous until you know how this medicine affects you. Stand up slowly if you feel dizzy or lightheaded.
• Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Confusion, unusual changes in mood or behaviors, behaviors you cannot control
• Extreme sleepiness or drowsiness
• Fever, muscle pain, stiffness, tenderness, or weakness
• Lightheadedness, dizziness, fainting
• Seeing, hearing, or feeling things that are not there
• Severe diarrhea
• Skin changes or growths
• Twitching or muscle movements you cannot control, tremors, problems with balance or walking

If you notice these less serious side effects, talk with your doctor:

• Brown urine
• Mild diarrhea, nausea, stomach pain

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088