Precautions and Warnings With Entacapone

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• A bile duct obstruction or gallbladder disease
• Lung problems, such as asthma or chronic obstructive pulmonary disease (COPD)
• Kidney disease, such as kidney failure (renal failure)
• Liver disease, such as liver failure, cirrhosis, or hepatitis
• Any allergies, including allergies to foods, dyes, or preservatives.
   

• Pregnant or thinking of becoming pregnant
• Breastfeeding.
   

• Entacapone should always be used in combination with carbidopa-levodopa products (such as Sinemet^®, Sinemet^® CR, or Parcopa^®). The drug has no activity against Parkinson's disease when used alone.
   
• Stopping the medication too quickly can cause a dangerous condition known as neuroleptic malignant syndrome (NMS). Do not stop taking entacapone without your healthcare provider's approval and supervision. Let your healthcare provider know if you develop any signs of NMS, such as:

• A high fever
• Irregular pulse or blood pressure
• A fast heart rate (tachycardia)
• Sweating
• Stiff muscles
• Confusion
• Irregular heart rhythms (arrhythmias).

• Entacapone often causes diarrhea. Sometimes, it can be severe enough to require hospitalization. This diarrhea can occur at any time, not just when starting the medication.
   
• Entacapone can cause low blood pressure (hypotension). Be sure to let your healthcare provider know if you develop signs of low blood pressure while taking it, such as lightheadedness, dizziness, or fainting.

• Intense, unusual urges have been reported in people taking Parkinson's disease medications. Examples include an intense desire to gamble or to engage in risky sexual behavior. Let your healthcare provider know right away if you experience any of these urges.
 
• People with Parkinson's disease have an increased risk for melanoma (a type of skin cancer). At this time, it is not clear if this is caused by Parkinson's disease medications or other factors. It is a good idea to have regular skin checks to monitor for this problem.
  

• The medication can cause hallucinations (seeing, hearing, or feeling things that are not really there). Let your healthcare provider know if you develop hallucinations while taking entacapone.
   
• Entacapone can cause involuntary muscle movements called dyskinesias. Although not usually dangerous, dyskinesias can be quite disturbing and intolerable. If you develop a dyskinesia while taking the drug, your healthcare provider may need to decrease your entacapone dosage, or you may need to stop taking it altogether.
   
• In animal studies, large doses of entacapone increased the risk of kidney problems in rats. It is not known if the drug would cause kidney problems in humans too.
   
• If you have bile or gallbladder problems, lung problems, ulcers, or kidney or liver disease, check with your healthcare provider before taking entacapone. In some cases, this medication may not be the best choice for you.
   
• The medication may cause you to fall asleep during the day, sometimes without warning. This can be especially dangerous if you are driving a car or operating heavy machinery. In addition, this can happen long after you start taking entacapone. Ask your healthcare provider if you should stop driving a car or operating heavy machinery while taking it.
   
• Entacapone can cause urine discoloration. This is not dangerous and is not a sign of other problems.
   
• Entacapone can potentially interact with several medications (see Drug Interactions With Entacapone).
   
• Entacapone is considered a pregnancy Category C medication. This means that it may not be safe for use during pregnancy, although the full risks are not known (see Comtan and Pregnancy).
   
• It is not known whether the medication passes through breast milk. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider prior to taking the entacapone (see Comtan and Breastfeeding).