Indications:

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:

What is MIRAPEX ER?

MIRAPEX ER is a prescription medicine used to treat the signs and symptoms of Parkinson’s disease.

What is MIRAPEX?

MIRAPEX is a prescription medicine used to treat:

  • the signs and symptoms of Parkinson’s disease.

What are the possible side effects of both MIRAPEX ER and MIRAPEX?

Both MIRAPEX ER and MIRAPEX may cause serious side effects, including:

  • falling asleep during normal daily activities.

    • MIRAPEX ER / MIRAPEX may cause you to fall asleep while you are doing daily activities such as driving, talking with other people, or eating.
      • Some people taking the medicine in MIRAPEX ER / MIRAPEX have had car accidents because they fell asleep while driving.
      • Some people did not feel sleepy before they fell asleep while driving. You could fall asleep without any warning.

      Tell your doctor right away if you fall asleep while you are doing activities such as talking, eating, driving, or if you feel sleepier than normal for you. Don’t drive or do other dangerous activity until you know how MIRAPEX ER / MIRAPEX affects you.

  • low blood pressure when you sit or stand up quickly. After you have been sitting or lying down, stand up slowly until you know how MIRAPEX ER / MIRAPEX affects you. This may help reduce the following symptoms:

    • dizziness
    • nausea
    • fainting
    • sweating

    Sit and stand up slowly after you have been sitting or lying down.

  • unusual urges. Some people who take certain medicines to treat Parkinson’s disease, including MIRAPEX ER / 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.

  • hallucinations and other psychotic-like behavior (seeing visions, hearing sounds or feeling sensations that are not real, confusion, excessive suspicion, aggressive behavior, agitation, delusional beliefs and disorganized thinking). Your chance of having hallucinations and other psychotic-like behavior is higher if you are age 65 or older.

    If you have hallucinations or other psychotic-like changes, talk with your doctor right away.

  • uncontrolled sudden movements (dyskinesia). If you have new dyskinesia, or your existing dyskinesia gets worse, tell your doctor.

  • skin cancer (melanoma). Some people with Parkinson’s disease may have a higher chance of having melanoma than people who do not have Parkinson’s disease. It is not known if the chance of having melanoma is higher because of the medicines to treat Parkinson’s disease, or from the Parkinson’s disease. People who take MIRAPEX ER / MIRAPEX should have regular skin examinations to check for melanoma.

Avoid alcohol when taking MIRAPEX ER or MIRAPEX. It can increase your chances of having serious side effects.

The most common side effects in people taking MIRAPEX ER for Parkinson’s disease are:

  • nausea and vomiting
  • constipation
  • dizziness
  • fatigue
  • dry mouth
  • swelling of the feet and ankles
  • headache
  • weight loss (anorexia)

The most common side effects in people taking MIRAPEX for Parkinson’s disease are:

  • nausea
  • dizziness
  • insomnia
  • constipation
  • muscle weakness
  • abnormal dreams
  • confusion
  • memory problems (amnesia)
  • urinating more often than usual

These are not all the possible side effects you could experience. Tell your doctor if you have any side effect that bothers you.

Before taking MIRAPEX ER or MIRAPEX, tell your doctor about all your medical conditions and about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

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.

Please see full Prescribing Information, including Patient Information, for MIRAPEX ER and MIRAPEX.

This information is intended for US residents only.

CARES Foundation If you can't afford your MIRAPEX or MIRAPEX ER,
our patient assistance program
may be able to help. Call 1-800-556-8317.