What is the most important information I should know about comtan?

Use caution when driving, operating machinery, or performing other hazardous activities. Entacapone may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities.

Dizziness may be more likely to occur when rising from a sitting or lying position. To avoid falls, rise slowly from a sitting or lying position.

Hallucinations may occur with comtan. Call your doctor if you experience hallucinations.

What is comtan?

When used with levodopa and carbidopa, comtan increases levels of levodopa (Dopar, Larodopa, Sinemet) in the body.

Entacapone is used with carbidopa and levodopa to treat patients with Parkinson's disease who experience the signs and symptoms of end-of-dose “wearing-off”. Entacapone is used only in combination with carbidopa and levodopa. It has no effect if it is used on its own.

Entacapone may also be used for purposes other than those listed in the medication guide.

Who should not take comtan?

Do not take comtan without first talking to your doctor if you

• have liver disease;
• are taking a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate); or
• have ever experienced muscle damage or elevated body temperature and confusion because of a medication.

You may not be able to take comtan, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Entacapone is in the FDA pregnancy category C. This means that it is not known whether comtan will harm an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant. It is not known whether comtan passes into breast milk. Do not take this medication without first talking to your doctor if you are breast-feeding a baby.

How should I take comtan?

Take comtan exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Entacapone should always be taken with levodopa/carbidopa. Entacapone has no antiparkinsonian effect of its own.

Take comtan with a full glass of water.

You can take comtan with or without food.

Do not stop taking comtan suddenly. You may require a gradual dosage reduction to prevent withdrawal effects. Store comtan at room temperature in a tight container away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take only your next regularly scheduled dose. Do not take a double dose of this medication.

What happens if I overdose?

Seek emergency medical attention.

Symptoms of an comtan overdose are not known.

What should I avoid while taking comtan?

Use caution when driving, operating machinery, or performing other hazardous activities. Entacapone may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities.

Dizziness may be more likely to occur when you rise from a sitting or lying position. To avoid falls, rise slowly.

Avoid alcohol or use it with caution while taking comtan. Alcohol may increase drowsiness while taking comtan.

What are the possible side effects of comtan?

If you experience any of the following serious side effects, stop taking comtan and seek emergency medical attention or notify your doctor immediately:

• an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);
• fever and confusion;
• muscle pain; or
• hallucinations.

Other, less serious side effects may be more likely to occur. Notify your doctor if you experience

• abnormal movements of the muscles;
• nausea or vomiting;
• discolored urine;
• diarrhea;
• abdominal pain;
• dry mouth;
• dizziness;
• anxiety;
• drowsiness;
• increased sweating; or
• shortness of breath.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect comtan?

Do not take comtan without first talking to your doctor if you are taking a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate). These medicines should not be taken with comtan.

Before taking comtan, tell your doctor if you are taking

• isoproterenol (Isuprel, Medihaler-Iso, Duo-Medihaler);
• epinephrine (Epi-Pen, Ana-Guard, Bronkaid Mist, Primatene Mist Inhaler, others);
• norepinephrine (Levophed Bitartrate);
• dopamine (Intropin);
• dobutamine (Dobutrex);
• methyldopa (Aldomet);
• isoetherine (Bronkosol, Bronkometer);
• bitolterol (Tornalate)
• probenecid (Benemid);
• cholestyramine (Questran, Prevalite, Locholest);
• erythromycin (Ery-Tab, E-Mycin, Eryc, PCE Dispertab, E.E.S., and others);
• rifampin (Rimactane, Rifadin); or
• ampicillin (Principen, Totacillin, Omnipen, and others).

You may not be able to take comtan, or you may require a dosage adjustment or special monitoring during treatment if you are taking any of the medicines listed above.

Entacapone may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, antihistamines, sedatives (used to treat insomnia), pain relievers, anxiety medicines, and muscle relaxants. Tell your doctor about all medicines that you are taking, and do not take any medicine unless your doctor approves.

Drugs other than those listed here may also interact with comtan. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.