IMPORTANT SAFETY INFORMATION
DO NOT take GOCOVRI if you have severe kidney problems.
WHAT SHOULD I AVOID WHILE TAKING GOCOVRI?
Do not stop or change the dose of GOCOVRI before talking with your doctor. Call your healthcare provider if you have symptoms of withdrawal such as fever, confusion, or severe muscle stiffness.
Do not drink alcohol while taking GOCOVRI as it can increase your chances of serious side effects.
Do not drive, operate machinery, or do other dangerous activities until you know how GOCOVRI affects you.
If you took too much GOCOVRI, call your doctor or go to the nearest hospital emergency room right away.
WHAT ARE THE POSSIBLE SIDE EFFECTS OF GOCOVRI?
- Falling asleep during normal activities. Activities may include driving, talking, or eating. You may fall asleep without being drowsy or warning.
- Suicidal thoughts or actions and depression. Tell your doctor if you have new or sudden changes in mood, behaviors, thoughts, or feelings, including thoughts about hurting yourself or ending your life.
- Hallucinations. GOCOVRI can cause or worsen hallucinations (seeing or hearing things that are not real) or psychotic behavior.
- Feeling dizzy, faint or lightheaded, especially when you stand up (orthostatic hypotension). Lightheadedness or fainting may happen when getting up too quickly after long periods of time, when first starting GOCOVRI, or if your dose has been increased.
- Unusual urges. Examples include gambling, sexual urges, spending money, binge eating, and the inability to control them.
The most common side effects of GOCOVRI include dry mouth, swelling of legs and feet, constipation, and falls. If you or your family notices that you are developing any new, unusual or sudden changes in behavior or related symptoms, tell your healthcare provider right away.
These are not all the possible side effects of GOCOVRI. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
TELL YOUR DOCTOR ABOUT ALL MEDICAL CONDITIONS, INCLUDING IF YOU:
- have kidney problems.
- have unexpected or unpredictable sleepiness, sleep disorders, or currently take medication to help you sleep or make you drowsy.
- are pregnant or plan to become pregnant or are breastfeeding or plan to breastfeed. GOCOVRI may harm your unborn baby and can pass into your breastmilk.
Tell your doctor about all the medicines you take. Include prescription and over-the-counter medicines, vitamins, and herbal supplements.
Especially tell your doctor if you take medicines like sodium bicarbonate, or have had or are planning to have a live flu vaccination (nasal spray). You can receive the flu vaccination shot but should not get a live flu vaccine while taking GOCOVRI.
WHAT IS GOCOVRI?
GOCOVRI® (amantadine) extended release capsules is a prescription medicine used:
- for the treatment of dyskinesia (sudden uncontrolled movements) in people with Parkinson’s disease who are treated with levodopa therapy or levodopa therapy with other medicines that increase the effects of dopamine in the brain.
- with levodopa and carbidopa in people with Parkinson’s disease who are having “off” episodes.
It is not known if GOCOVRI is safe and effective in children.
Please see full Patient Prescribing Information.