Ongentys is a prescription medicine that inhibits the enzyme catechol-O-methyltransferase (COMT). COMT is involved in the degradation of certian neurotransmitters such as dopamine, epinephrine, and norepinephrine.

Ongentys is used together with carbidopa and levodopa to treat symptoms of "off" episodes (stiffness, tremors, muscle spasms, poor muscle control) in people with Parkinson's disease.

It is not known if Ongentys is safe and effective in children.

Do not use Ongentys if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, tranylcypromine and others.

Do not use Ongentys if you have a tumor that secretes hormones known as catecholamines. These tumors include pheochromocytoma (a type of adrenal gland tumor) and paraganglioma.

Take Ongentys exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

When you start or stop taking Ongentys, your doctor may need to adjust the doses of any other medicines you take for Parkinson's disease.

Ongentys is usually taken at bedtime. Follow your doctor's dosing instructions very carefully.

Take Ongentys on an empty stomach. Do not eat for at least 1 hour before or 1 hour after taking this medicine.

Your blood pressure may need to be checked often.

Ongentys may cause you to fall asleep during normal daytime activities such as working, talking, eating, or driving. You may fall asleep suddenly, even after feeling alert. Tell your doctor if you have any problems with daytime sleepiness or drowsiness.

Do not change your doses or stop using any of your medicines without your doctor's advice. Tell your doctor if any of your medicines seem to stop working.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Parkinson's Disease:

50 mg orally once a day at bedtime

Use: As adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease (PD) experiencing "off" episodes

You should not use Ongentys if you are allergic to opicapone, or if you have a certain type of tumor that secretes hormones, such as:

• pheochromocytoma (tumor of the adrenal gland); or

• paraganglioma (tumor of the nerve cells).

To make sure Ongentys is safe for you, tell your doctor if you have ever had:

• a sleep disorder that causes daytime sleepiness;

• narcolepsy or other conditions that cause sudden sleepiness;

• uncontrolled muscle movements;

• unusual and intense urges to act on impulse (such as gambling, binge-eating, or compulsive shopping);

• mental illness, hallucinations, or psychosis;

• liver disease; or

• kidney disease.

Tell your doctor if you are pregnant or breastfeeding.

Skip the missed dose and use your next dose the following night. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid driving or hazardous activity until you know how this medicine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Get emergency medical help if you have signs of an allergic reaction to Ongentys: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;

• confusion, hallucinations (hearing or seeing something that is not there);

• aggression, agitation, unusual thoughts or behavior;

• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement); or

• worsening tremors, stiffness, or muscle spasms.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking this medicine. Talk with your doctor if this occurs.

Common Ongentys side effects may include:

• feeling light-headed;

• uncontrolled muscle movement;

• abnormal blood tests;

• constipation; or

• weight loss.

When you stop taking Ongentys, watch for withdrawal symptoms such as: stiff muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, or feeling like you might pass out.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Using Ongentys with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Tell your doctor about all your other medicines, especially:

• dobutamine;

• dopamine;

• epinephrine, norepinephrine; or

• isoproterenol.

This list is not complete. Other drugs may interact with opicapone, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.