Entacapone (By mouth)

Warnings While Using This Medicine

• Entacapone may make you dizzy or sleepy, especially when you first start using the medicine. Avoid driving or using machinery until you know how the medicine affects you.
• Dizziness may be worse if you get up too fast after sitting or lying down. Getting up slowly from a sitting or lying position may help.
• Check with your doctor before using this medicine if you have liver or gallbladder disease.
• Talk to your doctor before using this medicine if you are pregnant, planning to become pregnant, or breastfeeding.
• Do not suddenly stop using this medicine. You may need to use smaller and smaller doses before completely stopping the medicine, and your doctor may need to change your doses of levodopa/carbidopa.
• This medicine may cause your urine to become a brownish orange color. This is normal.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Severe diarrhea
• Uncontrolled body movements or severe stiffness
• Unexplained high fever
• Wheezing or trouble breathing
• Worsening of your symptoms of Parkinson's disease

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

• Blurred vision
• Dizziness or lightheadedness
• Hallucinations or confusion
• Mild diarrhea
• Nausea, vomiting, abdominal pain

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

Introduction

Entacapone (en-TAK-a-pone)

Is given with levodopa/carbidopa to treat symptoms of Parkinson's disease, such as tremors, stiffness, slow movement, and problems with balance.

Brand Name(s)

Comtan

When This Medicine Should Not Be Used

How to Use This Medicine

Tablet

• Your doctor will tell you how much medicine to use and how often.
• This medicine is given with levodopa/carbidopa (Sinemet® or Sinemet CR®), because it helps levodopa work in your body for a longer amount of time. Be sure to get an information sheet for Sinemet®/Sinemet CR®.
• While you are using entacapone, your doctor may change your levodopa/carbidopa dose, or the time between doses. Use all of your medicines exactly as your doctor ordered.
• You may take entacapone with or without food. If the medicine upsets your stomach, try taking it with food.

If a dose is missed:

• Use the missed dose as soon as possible, unless it is almost time for your next dose.
• Skip the missed dose if it is almost time for your next regular dose.
• You should not use two doses at the same time.

How to Store and Dispose of This Medicine

• Store the tablets at room temperature, away from heat, moisture, or direct light.
• Keep all medicine out of the reach of children.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• You should not use MAO inhibitors (such as Nardil® or Parnate®) while using this medicine.
• Make sure your doctor knows if you are using any inhalers for breathing problems before using this medicine.
• Check with your doctor before using entacapone if you are using alcohol or other medicines that make you sleepy such as sleeping pills, cold and allergy medicine, medicines for depression or nervousness, or strong pain killers.