Amneal markets and distributes ONGENTYS® in the U.S.
ONGENTYS® (opicapone) capsules is a prescription medicine used with levodopa and carbidopa in people with Parkinson's disease (PD) who are having "OFF" episodes. Visit www.Ongentys.com for more information.
It is not known if ONGENTYS is safe and effective in children.
IMPORTANT SAFETY INFORMATION
Do not take ONGENTYS if you:
• take a type of medicine called a non-selective monoamine-oxidase (MAO) inhibitor.
• have a tumor that secretes hormones known as catecholamines.
Before taking ONGENTYS, tell your healthcare provider about all of your medical conditions, including if you:
• have daytime sleepiness from a sleep disorder, have unexpected periods of sleep or sleepiness, or take a medicine to help you sleep or that makes you feel sleepy.
• have had intense urges or unusual behaviors, including gambling, increased sex drive, binge eating, or compulsive shopping.
• have a history of uncontrolled sudden movements (dyskinesia).
• have had hallucinations or psychosis.
• have liver or kidney problems.
• are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take nonselective MAO inhibitors (such as phenelzine, tranylcypromine, and isocarboxazid) or catecholamine medicines (such as isoproterenol, epinephrine, norepinephrine, dopamine, and dobutamine), regardless of how you take the medicine (by mouth, inhaled, or by injection).
ONGENTYS and other medicines may affect each other causing side effects. ONGENTYS may affect the way other medicines work, and other medicines may affect how ONGENTYS works.
What should I avoid while taking ONGENTYS?
• Do not drive, operate machinery, or do other dangerous activities until you know how ONGENTYS affects you.
What are the possible side effects of ONGENTYS?
ONGENTYS may cause serious side effects, including:
• Falling asleep during normal activities such as driving a car, talking or eating while taking ONGENTYS or other medicines used to treat Parkinson's disease, without being drowsy or without warning. This may result in having accidents. Your chances of falling asleep while taking ONGENTYS are higher if you take other medicines that cause drowsiness.
• Low blood pressure or dizziness, light headedness, or fainting.
• Uncontrolled sudden movements (dyskinesia). ONGENTYS may cause uncontrolled sudden movements or make such movements worse or happen more often.
• Seeing, hearing, or feeling things that are not real (hallucinations), believing things that are not real (delusions), or aggressive behavior.
• Unusual urges (impulse control and compulsive disorders) such as urges to gamble, increased sexual urges, strong urges to spend money, binge eating, and the inability to control these urges.
Tell your healthcare provider if you experience any of these side effects or notice changes in your behavior.
The most common side effects of ONGENTYS include uncontrolled sudden movements (dyskinesia), constipation, increase in an enzyme called blood creatine kinase, low blood pressure, and weight loss.
These are not all of the possible side effects of ONGENTYS. Call your healthcare provider for medical advice about side effects.
To report SUSPECTED ADVERSE REACTIONS, contact Amneal Specialty, a division of Amneal Pharmaceuticals, LLC at 1-877-835-5472 or the FDA at 1-800-FDA-1088 or fda.gov/medwatch
Please see ONGENTYS full Product Information: www.ongentys.com/assets/pdf/ONGENTYS-full-Prescribing-Information.pdf