Opicapone (oh-PIK-a-pone)

Treats "off" episodes in patients with Parkinson disease.

Brand Name(s):

Ongentys

When This Medicine Should Not Be Used:

How to Use This Medicine:

Capsule

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• It is best to take this medicine on an empty stomach. Take this medicine at bedtime. Do not eat 1 hour before and at least 1 hour after using this medicine.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Skip the missed dose and go back to your regular dosing schedule. 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 use this medicine together with non-selective MAO inhibitors (including isocarboxazid, phenelzine, tranylcypromine).
• Some medicines can affect how opicapone works. Tell your doctor if you are using dobutamine, dopamine, epinephrine, isoproterenol, or norepinephrine.
• 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 kidney disease, liver disease, heart problems, sleeping problems, or a history of dyskinesia (trouble controlling movements) or mental illness.
• This medicine may cause the following problems:
  • Heart problems and changes in blood pressure (when used together with other medicines)
  • New or worsening dyskinesia
  • Unusual changes in thoughts or behavior, including the urge to gamble or an increased sex drive
• This medicine may make you drowsy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
• Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely.
• 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
• Compulsive behavior or intense urges you cannot control
• Excessive drowsiness
• Fast, slow, or uneven heartbeat
• Jerky muscle movement you cannot control (often in your face, tongue, or jaw)
• Lightheadedness, dizziness, or fainting
• Unusual behavior, mood changes, seeing or hearing things that are not there, or thoughts of hurting yourself

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

• Constipation
• Weight loss

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