About OSMOLEX ER

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OSMOLEX ER is a prescription medication used to treat adults with:

  • Parkinson’s disease
  • Drug-induced extrapyramidal reactions
It is not known if OSMOLEX ER is safe and effective in children.
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Parkinson’s Disease

  • Parkinson's disease is the second most common neurodegenerative disorder after Alzheimer’s disease
  • Symptoms include tremor or shaking, rigidity or stiffness, extreme slowness of movement, and impaired balance
  • Approximately 60,000 people are diagnosed with Parkinson’s disease in the United States every year
  • An estimated 1 million people in the United States have the disease
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Drug-Induced Extrapyramidal Reactions

  • Characterized by intermittent or sustained involuntary movements in the face, neck, trunk, pelvis, extremities, and/or larynx
  • Are reversible effects to the nerves associated with motor activity
  • Occur after the administration of certain medications, such as: antipsychotics, gastrointestinal motility drugs, calcium channel blockers, and anti-epileptic drugs
  • Symptoms can begin immediately after administration or be delayed by hours or days
  • Are rarely life-threatening, but can cause distress for patients and their families

Key features

  • OSMOLEX ER has a unique drug-delivery system that delivers amantadine throughout the day
  • OSMOLEX ER is taken once daily in the morning

The exact cause of Parkinson's disease is unknown; however, research has identified several genes that can cause rare inherited forms of Parkinson's disease and other genes that influence age of onset and susceptibility.

Osmodex® Drug Delivery System

OSMOLEX ER has a unique drug-delivery system that delivers amantadine throughout the day.

OSMOLEX ER contains amantadine in an immediate-release outer layer and an extended-release core that is delivered using the Osmodex® Drug Delivery System.*

*The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the stool as a tablet shell.

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Important Safety Information

What is OSMOLEX ER (amantadine) extended release tablets?

OSMOLEX ER is a prescription medicine used to treat adults with:

  • Parkinson’s disease
  • Drug-induced extrapyramidal reactions

It is not known if OSMOLEX ER is safe and effective in children.


BEFORE TAKING OSMOLEX ER, TELL YOUR DOCTOR ABOUT ALL MEDICAL CONDITIONS, INCLUDING IF YOU:

  • have kidney problems. Do not take OSMOLEX ER if you have severe kidney problems
  • have unexpected sleepiness, take medicine to help you sleep or that makes you drowsy
  • have mental problems, such as suicidal thoughts, depression, or hallucinations
  • have unusual urges, including gambling, increased sex drive, compulsive eating, or compulsive shopping
  • drink alcoholic beverages
  • are pregnant or plan to become pregnant or are breastfeeding or plan to breastfeed. OSMOLEX ER may harm your unborn baby and can pass into your breastmilk

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your doctor if you take sodium bicarbonate, a medicine that contains sodium bicarbonate, or are planning to receive the flu vaccine.


WHAT SHOULD I AVOID WHILE TAKING OSMOLEX ER?

  • Do not drive, operate heavy machinery, or do other dangerous activities until you know how OSMOLEX ER affects you
  • You should not drink alcohol while taking OSMOLEX ER because it can increase your chances of serious side effects
  • Do not stop taking OSMOLEX ER or change your dose before talking with your doctor. Tell your doctor if you have symptoms of withdrawal such as fever, confusion, or severe muscle stiffness
  • You may receive the flu vaccine (shot or injection) but should not get the live flu vaccine (nasal spray) while taking OSMOLEX ER

WHAT ARE THE POSSIBLE SIDE EFFECTS OF OSMOLEX ER?

OSMOLEX ER may cause serious side effects, including:

  • falling asleep during normal activities, such as driving, talking, or eating, while taking OSMOLEX ER. You may fall asleep without being drowsy or warning. The risk is greater if you take OSMOLEX ER with other medicines that cause drowsiness or drink alcohol. Tell your doctor right away if this happens
  • suicidal thoughts or actions and depression. Tell your doctor right away if you have significant changes in your mood, behaviors, or thoughts, including thoughts about hurting yourself or ending your life
  • hallucinations (seeing, or hearing things that are not real) while you are taking OSMOLEX ER or if you suddenly stop taking OSMOLEX ER
  • feeling dizzy, faint, or light-headed, especially when you stand up too quickly, when you first start OSMOLEX ER, or if your dose has been increased. Tell your doctor if you become dizzy, light-headed, or faint when standing up
  • unusual urges, including gambling, sexual, spending money, and binge eating, and the inability to control these urges. If you notice or your family notices that you are developing any unusual behaviors, talk to your doctor

The most common side effects of OSMOLEX ER include nausea, dizziness, lightheadedness, and trouble sleeping.


These are not all the possible side effects of OSMOLEX ER. Call your doctor for medical advice about side effects.You may report side effects to the FDA. Visit www.fda.gov/medwatch or call at 1-800-FDA-1088.