Opicapone capsules

What is this medication?

OPICAPONE (oh PI ca pone) is used in combination with levodopa; carbidopa therapy to treat Parkinson's disease.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): ONGENTYS

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• if you drink alcohol
• kidney disease
• liver disease
• low blood pressure
• narcolepsy
• schizophrenia
• sleep apnea
• an unusual or allergic reaction to opicapone, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Take this medicine on an empty stomach. Do not eat for 1 hour before and for at least 1 hour after taking this medicine. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician about the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, skip it. Take your next dose at the normal time. Do not take extra or 2 doses at the same time to make up for the missed dose.

What may interact with this medication?

Do not take this medicine with any of the following medications:

• MAOIs like Marplan, Nardil, and Parnate

This medicine may also interact with the following medications:

• alcohol
• antihistamines for allergy, cough, and cold
• certain medicines for anxiety or sleep
• certain medicines for depression like amitriptyline, fluoxetine, sertraline
• certain medicines for seizures like phenobarbital, primidone
• dobutamine
• dopamine
• epinephrine
• general anesthetics like halothane, isoflurane, methoxyflurane, propofol
• isoproterenol
• medicines that relax muscles for surgery
• narcotic medicines for pain
• norepinephrine
• phenothiazines like chlorpromazine, mesoridazine, prochlorperazine, thioridazine

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your health care professional for regular checks on your progress. Tell your health care professional if your symptoms do not start to get better or if they get worse. Do not stop taking except on your health care professional's advice. You may develop a severe reaction. Your health care professional will tell you how much medicine to take.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.

When taking this medicine, you may fall asleep without notice. You may be doing activities like driving a car, talking, or eating. You may not feel drowsy before it happens. Contact your health care provider right away if this happens to you.

There are have been reports of increased sexual urges or other strong urges such as gambling while taking this medicine. If you experience any of these while taking this medicine, you should report this to your health care professional as soon as possible.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy and drinking plenty of water may help. Contact your health care professional if the problem does not go away or is severe.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives; swelling of the face, lips, or tongue
• changes in emotions or moods
• falling asleep during normal activities like driving
• hallucinations
• high blood pressure
• new or increased gambling urges, sexual urges, uncontrolled spending, binge or compulsive eating, or other urges
• signs and symptoms of low blood pressure like dizziness; feeling faint or lightheaded, falls; unusually weak or tired
• uncontrollable movements of the arms, face, head, mouth, neck, or upper body

Side effects that usually do not require medical attention (report these to your doctor or health care professional if they continue or are bothersome):

• constipation
• drowsiness
• dry mouth
• trouble sleeping

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children.

Store at room temperature below 30 degrees C (86 degrees F). Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.