Ongentys (Opicapone)

Please read the instructions before using Ongentys capsules.

Follow your doctor's prescription exactly. Take Ongentys (opicapone) once daily at bedtime. Avoid eating for 1 hour before and after taking your dose.

If you miss a dose, take your usual dose the next day at bedtime. Do not stop taking Ongentys or change your dose without consulting your doctor. Stopping suddenly may affect your Parkinson’s medications. Tell your doctor if you experience withdrawal symptoms like fever, confusion, or severe muscle stiffness.

If you take too much Ongentys, call your doctor or Poison Control at 1-800-222-1222, or go to the nearest emergency room immediately.

What to Avoid While Taking Ongentys capsule?

Do not drive, operate machinery, or perform dangerous tasks until you know how Ongentys affects you.

What are the ingredients in Ongentys capsule?

Active ingredient: opicapone Inactive ingredients: lactose, magnesium stearate, pregelatinized starch, and sodium starch glycolate. The capsule shells contain: FD&C Blue#2, FD&C Red#3, gelatin, and titanium dioxide.

Common side effects include: Uncontrolled sudden movements (dyskinesia), low blood pressure, constipation, weight loss, and increased levels of blood creatine kinase.

Serious side effects may include:

• Falling asleep suddenly. You may fall asleep without warning while doing normal activities like driving, eating, or talking. This risk increases if you take other drowsy medications.
• Low blood pressure and dizziness. Ongentys may cause dizziness, lightheadedness, or fainting. Tell your doctor if this happens.
• Uncontrolled movements. Ongentys may cause new or worsened involuntary movements. Inform your doctor if this occurs.
• Hallucinations and delusions. You may see, hear, or believe things that are not real, or show aggressive behavior. Report any changes in behavior to your doctor.
• Unusual urges. Some people develop compulsive behaviors, such as excessive gambling, spending, eating, or increased sexual urges. Tell your doctor if you notice these changes.

This is not a complete list of possible side effects. For a full list, ask your doctor or pharmacist.

Before you take Ongentys, tell your healthcare provider if you:

• Have daytime sleepiness, unexpected sleep episodes, or take medications that cause drowsiness.
• Have or have had compulsive behaviors, such as gambling, binge eating, or excessive shopping.
• Have a history of uncontrolled sudden movements (dyskinesia).
• Have or have had hallucinations or psychosis.
• Have liver or kidney problems.
• Are pregnant or planning to become pregnant. It is unknown if Ongentys affects unborn babies.
• Are breastfeeding or planning to breastfeed. It is unknown if Ongentys passes into breast milk.

Tell your healthcare provider about all medicines you take, including prescription drugs, over-the-counter medicines, vitamins, and herbal supplements. Especially mention if you take nonselective MAO inhibitors (such as phenelzine or tranylcypromine) or catecholamine medicines (such as epinephrine or dopamine), as they may interact with Ongentys.

How should I store Ongentys?

Store Ongentys at a temperature below 86°F (30°C). Keep this drug and all medicines out of the reach of children.

Brand Name:	Ongentys
Generic name:	Opicapone
Other Names:	Ongentys
Strength(s):	50mg
Quantities Available:	90
Formulation:	Capsule