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- MIRAPEX ER Prescribing Information.
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New Engl J Med. 2012;366:511-519.
Mirapex® ER (pramipexole dihydrochloride) extended-release tablets and Mirapex® (pramipexole dihydrochloride) tablets are prescription medicines to treat the signs and symptoms of Parkinson's disease (PD).
Important Safety Information:
MIRAPEX ER or MIRAPEX may cause you to fall asleep without warning during daily activities, including talking, eating, and driving, which may result in accidents. Tell your doctor if you feel new or increased sleepiness while taking MIRAPEX ER or MIRAPEX. Do not drive a car, operate a machine, or do anything that needs you to be alert until you know how MIRAPEX ER or MIRAPEX affects you.
Before taking MIRAPEX ER or MIRAPEX, talk to your doctor about all of your medical conditions, including if you feel sleepy during the day. Tell your doctor if you drink alcohol or take other medications that make you drowsy, as these can increase the chance that MIRAPEX ER or MIRAPEX will make you feel sleepy or fall asleep when you should be awake.
When taking MIRAPEX ER or MIRAPEX, hallucinations (unreal visions, sounds or sensations) may occur and you may sometimes feel dizzy, nauseated, faint or sweaty when you sit up or stand quickly.
Some patients taking certain medicines to treat PD, including MIRAPEX ER and MIRAPEX, have reported problems, such as gambling, compulsive eating, compulsive buying, and increased sex drive. If you or your family members notice that you are developing unusual urges or behaviors, talk to your doctor.
The most common side effects in people taking MIRAPEX ER for early PD are sleepiness, nausea and vomiting, constipation, dizziness, tiredness, hallucinations, dry mouth, muscle spasms, and edema (swelling of the feet and ankles). The most common side effects in people taking MIRAPEX ER who have later-stage PD are abnormal movements, nausea, constipation, hallucinations, headache, and anorexia.
The most common side effects in people taking MIRAPEX for PD are nausea, dizziness, constipation, insomnia, muscle weakness, confusion, abnormal movements, abnormal dreams, memory problems (amnesia), and urinating more often than normal.
These are not all the possible side effects of MIRAPEX ER and MIRAPEX. Tell your doctor if you have any side effect that bothers you.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.
This information is intended for U.S. residents only.
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