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IMPORTANT SAFETY INFORMATION for patients

 

 

 

 

STALEVO is a prescription medication for the treatment of idiopathic (unknown cause) Parkinson's disease (PD) if you are experiencing a return of symptoms before your next dose ("wearing-off") of carbidopa/levodopa (only if you are taking a total daily dose of levodopa of 600 mg or less and not experiencing uncontrolled movements called dyskinesias).
 

STALEVO is a tablet combining 3 medications known as carbidopa, levodopa, and entacapone, so it may be used to replace these medications if you are taking them in separate tablets.

 

COMTAN is a prescription medication used as an add-on to the medications known as carbidopa/levodopa when worsening of PD signs and symptoms are occurring before your next dose (known as "wearing-off").

 
Important Safety Information
 

You should not take STALEVO or COMTAN with an antidepressant medication class known as nonselective monoamine oxidase (MAO) inhibitors. STALEVO or COMTAN may be used with selective MAO type B inhibitors, so make sure you tell your health care professional (HCP) about all of the medications you take, including nonprescription medications and supplements.

 

Do not take STALEVO if you have an eye problem known as glaucoma or have a history of or currently have active skin cancer or abnormal skin growths.

 

Tell your HCP about any health problems you might have or if you experience any side effects while taking STALEVO or COMTAN. Tell your HCP if you: have or develop uncontrolled sudden movements (called dyskinesias); have a history of or currently have mental problems, such as psychosis or depression with thoughts of suicide; have severe heart or lung disease, asthma, kidney, liver, or gall bladder disease; have endocrine disease (a hormone disorder); or have a history of heart attacks or ulcers.

 

Some serious side effects that may occur with STALEVO or COMTAN include symptoms resembling neuroleptic malignant syndrome (a condition characterized by fever and muscle stiffness); low blood pressure; severe diarrhea; hallucinations; and severe dyskinesias (uncontrolled movements). Rare events may include serious muscle problems or muscle aches, high fever, confusion, a lung condition called fibrosis, and skin cancer.

 

While taking STALEVO or COMTAN you may notice that your saliva, urine, or sweat may be a dark brown or brownish-orange color. Although the color is harmless, it may causing staining.

 

Some patients taking STALEVO or COMTAN develop an unusual urge to gamble or increased sexual urges and behaviors.

 

The most common side effects of entacapone (a component of STALEVO and COMTAN) include dyskinesias (uncontrolled movements), nausea, an increase in movement (called hyperkinesia), a change in the color of your urine, diarrhea, a decrease in movement (called hypokinesia), dizziness, stomach pain, constipation, and fatigue.

 

Tell your HCP if you have side effects that bother you. He or she can make adjustments that may reduce those effects. You should not quickly lower your STALEVO or COMTAN dose or suddenly stop taking it altogether. Be sure to take your medicine as instructed.

 

Click here for full Prescribing Information for STALEVO.

 

Click here for full Prescribing Information for COMTAN.

 
 
 
 
 
 
 
 
 
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