Opicapone 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.

Opicapone may also be used for purposes not listed in this medication guide.

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

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

Follow all directions 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 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 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 used 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.

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.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from light, excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

Avoid driving or hazardous activity until you know how opicapone 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: 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.

Using opicapone 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 affect opicapone, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.