OSMOLEX® ER (amantadine) extended release tablets is indicated for the treatment of Parkinson’s disease and for the treatment of drug-induced extrapyramidal reactions in adult patients.
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.