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Carbidopa/Levodopa/Entacapone (Oral) (Tablet)

Carbidopa/Levodopa/Entacapone (By mouth)
Carbidopa (kar-bi-DOE-pa), Entacapone (en-TAK-a-pone), Levodopa (lee-voe-DOE-pa)Treats symptoms of Parkinson disease.
Stalevo 100 , Stalevo 125 , Stalevo 150 , Stalevo 200 , Stalevo 50 , Stalevo 75

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 carbidopa, levodopa, or entacapone, or if you have narrow-angle glaucoma.

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.
  • Swallow the tablet whole. Do not crush, chew, or break it.
  • 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.

  • Do not take this medicine if you are also using phenelzine or tranylcypromine.
  • Some foods and medicines can affect how this medicine works. Tell your doctor if you are taking any of the following:
    • Apomorphine, cholestyramine, dobutamine, dopamine, epinephrine, isoniazid, isoproterenol, methyldopa, metoclopramide, norepinephrine, papaverine, phenytoin, probenecid, risperidone, selegiline, or warfarin
    • An antibiotic (such as ampicillin, chloramphenicol, erythromycin, rifampicin), blood pressure medicine, medicine to treat depression or mental illness, a phenothiazine medicine, or vitamin supplements that contain iron
  • High-protein foods can affect how your body absorbs this medicine. Talk to your doctor before you make any changes to your diet.
  • 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, diabetes, glaucoma, low blood pressure, lung disease, a sleep disorder, a history of stomach ulcers, or a history of depression or mental illness.
  • This medicine may cause the following problems:
    • Low blood pressure
    • Dyskinesia (trouble controlling movements)
    • Unusual changes in mood or behavior, compulsive behaviors, hallucinations
    • Possible increased risk for skin cancer
  • Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely.
  • Tell your doctor if your Parkinson symptoms come back between doses.
  • 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.
  • This medicine may cause your saliva, sweat, or urine to become dark red, brown, or black. This is nothing to worry about, but it could stain your clothes.
  • Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
  • Your doctor will do lab tests at regular visits to check on the effects of this medicine. 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, sweating, muscle stiffness, uneven heartbeat
  • Lightheadedness, dizziness, fainting
  • Muscle pain, tenderness, or weakness
  • Seeing or hearing things that are not really there
  • Severe diarrhea
  • Skin changes or growths
  • Twitching or muscle movements you cannot control (either new or worse than usual)

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

  • Mild diarrhea, nausea, or vomiting, stomach pain
  • Discolored urine, sweat, or saliva

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