Opicapone

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

Opicapone may also be used for reasons not mentioned in this medication guide.

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

Follow all instructions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Opicapone is usually taken at bedtime, on an empty stomach.

Do not eat for at least 1 hour before or 1 hour after taking opicapone.

Your blood pressure may need to be checked often.

Opicapone may cause you to fall asleep during normal daytime activities such as working, talking, eating, or driving. You may fall asleep suddenly, even if you feel alert. Tell your doctor if you have any issues 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.

Use only as directed. Inform your doctor if you are taking other medicines, have other medical conditions, or have allergies.

You should not use opicapone if you are allergic to it, 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).

Do not use opicapone if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, and tranylcypromine.

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.

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

Opicapone may cause serious side effects. 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 opicapone. Talk with your doctor if this occurs.

Common side effects of opicapone may include:

• feeling light-headed;
• uncontrolled muscle movement;
• abnormal blood tests;
• constipation; or
• weight loss.

When you stop taking opicapone, 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.

Usual Adult Dose for Parkinson's Disease:

50 mg orally once a day at bedtimeUse: As adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease (PD) experiencing "off" episodes

Skip the missed dose and take your next dose the following night. Do not take two doses at the same 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 opicapone will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Using opicapone with other medications that cause drowsiness can make you feel even more tired. Talk to your doctor before using opioid medications, sleeping pills, muscle relaxers, or medicines for anxiety or seizures.

Inform your doctor about all your other medications, especially:

• dobutamine;
• dopamine;
• epinephrine, norepinephrine; or
• isoproterenol.

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