In the U.S.—

• Antidyskinetic

Entacapone ( in-TACK-a-pohn) is used in combination with levodopa/carbidopa to treat Parkinson's disease, sometimes referred to as shaking palsy. Some patients experience signs and symptoms of end-of-dose “wearing-off” effect despite taking levodopa/carbidopa. Entacapone enhances the effect of levodopa/carbidopa. By improving muscle control, this medicine allows more normal movements of the body.

This medicine is available only with your doctor's prescription, in the following dosage forms:

• Tablets (U.S.)

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

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to entacapone. Also tell your doctor and pharmacist if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Entacapone has not been studied in pregnant women. However, studies in animals have shown that entacapone causes problems with the development of offspring. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding— It is not known whether entacapone passes into breast milk.

Children—Studies on this medicine have been done only in adult patients. There is no identified potential use of entacapone in children.

Older adults— Many medicines have not been tested in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. In studies done to date that included elderly people, entacapone did not cause different side effects or problems in older people than it did in younger adults.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking entacapone, it is especially important that your doctor and pharmacist know if you are taking any of the following:

• Apomorphine (e.g., Zydis) or
• Bitolterol (e.g., Tornalate) or
• Epinephrine (e.g., Adrenalin) or
• Isoetherine (e.g., Bronkosol) or
• Isoproterenol (e.g., Isuprel) or
• Methyldopa (e.g., Aldomet)—Taking these medications with entacapone may cause a fast or irregular heartbeat and excessive changes in blood pressure.

• Monoamine oxidase (MAO) inhibitors (furazolidone [e.g., Furoxone]. isocarboxazid [e.g., Marplan], phenelzine [e.g., Nardil], procarbazine [e.g., Matulane], tranylcypromine [e.g., Parnate])—Taking these medicines with entacapone may cause serious unwanted effects.

• Liver problems—Side effects of entacapone may be increased because of a slower removal from the body.

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

Dosing—

The dose of entacapone will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of entacapone. If your dose is different, do not change it unless your doctor tells you to do so.

Entacapone is always used in combination with levodopa/carbidopa (Sinemet); never alone.

The number of times a day you take the tablets depends on how often you take levodopa/carbidopa (Sinemet).

• For oral dosage form (tablets):
  • For Parkinson's disease:
    • Adults—200 mg with each levodopa/carbidopa (Sinemet) dose. Entacapone may be taken up to 8 times a day, but the total daily dose is usually not more than 1600 mg..
    • Children— Use and dose must be determined by your doctor.

Missed dose—

Always take with your levodopa/carbidopa (Sinemet). If you miss a dose of this medicine, take it as soon as possible. However, if your next scheduled dose is within 2 hours, skip the missed 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.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.

It is important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

Do not stop taking entacapone without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping completely.

Nausea may occur, especially when you first start taking this medicine. Also, an increase in body movements and twitching, twisting, or uncontrolled movements of the tongue, lips, face, arms or legs may occur. Your doctor may need to adjust your dose of levodopa/carbidopa if these movements occur.

This medicine may cause some people to become dizzy or drowsy. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. Getting up slowly may help. If you should have this problem, check with your doctor.

Hallucinations (seeing, hearing, or feeling things that are not there) may occur in some patients.

Entacapone may cause your urine to turn brownish orange. This effect is harmless and will go away after you stop taking the medicine.

Along with its needed effects, a medicine may cause 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 as soon as possible if any of the following side effects occur:

• More common
  • Absence of or decrease in body movements;  hyperactivity;  increase in body movements;  seeing, hearing, or feeling things that are not there;  twitching;  twisting;  uncontrolled repetitive movements of tongue, lips, face, arms, or legs 
  
  

• Less common
  • Fever or chills;  cough or hoarseness ;  lower back or side pain;  painful or difficult urination 
  
  

• Rare
  • Confusion;  muscle cramps;  pain;  shortness of breath;  stiffness ;  weakness;  unusual tiredness 
  
  

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome.

• More Common
  • Abdominal pain;  constipation;  diarrhea;  dizziness;  fatigue;  nausea 
  
  

• Less common
  • Acid or sour stomach ;  anxiety;  belching;  bruising;  burning feeling in chest or stomach;  heartburn;  difficult or labored breathing;  dry mouth;  indigestion;  insomnia ;  irritability;  loss of strength or energy;  muscle pain or weakness;  nervousness;  passing gas;  sleepiness or unusual drowsiness;  small, red spots on skin;  stomach discomfort, upset or pain;  sweating increased;  restlessness;  tenderness in stomach area;  tightness in chest;  tremor;  shortness of breath;  unusual or unpleasant (after) taste;  unusual weak feeling;  wheezing 
  
  

This medicine may cause your urine to turn brownish orange. This effect is harmless and will go away after you stop taking the medicine.

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