Patient InformationImportant Safety InformationFor Healthcare Professionals

Starting OSMOLEX® ER (amantadine)

Once you and your doctor have decided that Osmolex ER is right for you, your prescription will be fulfilled through the AccessOsmolex® support center as Osmolex ER is not available in retail pharmacies.

What is AccessOsmolex?

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AccessOsmolex is a support service center that is used to fulfill your Osmolex ER prescriptions.
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For patients interested in financial support, AccessOsmolex helps provide adult patients with information on coverage and affordability options for their treatment.
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You will have to sign a patient authorization form to complete the enrollment, but your doctor will handle the rest
AccessOsmolex™ support center icon

If you have already been prescribed OSMOLEX® ER and have questions about your prescription,

call the AccessOsmolex Support Center at 1-833-OSMOLEX (1-833-676-6539).

What other resources are available to Parkinson’s disease patients?

There are many organizations focused on research, advocacy, care, and support for the Parkinson’s disease community. These include national nonprofits, medical and research centers, government agencies, regional support groups, and advocacy groups. Each has its own special focus, but all share the common goals of improving the lives of those affected by Parkinson’s disease and someday finding a cure.

Such groups provide support and information to the Parkinson’s disease community, including those who have been diagnosed with Parkinson’s disease or parkinsonism, and their caregivers, families, friends, and healthcare providers.

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The list of resources above is not exhaustive. These links are to resources created by independent third parties and Adamas does not endorse any of these resources or the entities sponsoring these links.

References:

  1. Medicare Part D: A First Look at Prescription Drug Plans in 2018. Henry J. Kaiser Family Foundation website. https://www.kff.org/report-section/medicare-part-d-a-first-look-at-prescription-drug-plans-in-2018-findings/. Published October 13, 2017. Accessed April 12, 2018.
  2. 2017 Employer Health Benefits Survey. Henry J. Kaiser Family Foundation website. https://www.kff.org/report-section/ehbs-2017-section-9-prescription-drug-benefits/. Published September 19, 2017. Accessed April 12, 2018.

WHAT IS OSMOLEX® ER (AMANTADINE) EXTENDED RELEASE TABLETS?

OSMOLEX ER is a prescription medicine used to treat:

  • Parkinson’s disease
  • Drug-induced extrapyramidal reactions in adult patients

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

IMPORTANT SAFETY INFORMATION

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
  • You should not drink alcohol during treatment with Osmolex due to increased chances of serious side effects
  • 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. You may receive the flu vaccine shot but should not get a live flu vaccine (nasal spray) while taking OSMOLEX ER

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

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 FDA.

Visit www.fda.gov/medwatch or call at 1-800-FDA-1088.

Please see full Patient Prescribing Information.