MIRAPEX FOR HEALTHCARE PROFESSIONALS

Frequently Asked Questions

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What is RLS?
What is the difference between primary and secondary RLS?
What are the symptoms of RLS?
What is MIRAPEX?
What important information about MIRAPEX should I know?
What important things should I tell my doctor?
How is MIRAPEX taken to treat RLS?
What are the possible side effects of MIRAPEX?
How should I store MIRAPEX?


What is RLS?

RLS can begin as a strange feeling in your legs that seems to get worse until you stand up and move around. Deep inside your legs you can feel burning, creeping, and crawling sensations that are hard to describe, even to your doctor. Meanwhile, you cope with your condition the best you can.

If these symptoms describe the way you are feeling, you may have restless legs syndrome (RLS), a sensorimotor condition that affects millions of Americans. Movement will often relieve RLS symptoms briefly. Restless legs syndrome gets worse when you don't move or when relaxing, especially during the evening. Your sleep may be disturbed enough for you to be exhausted the following day.

What is the difference between primary and secondary RLS?

Some researchers believe that RLS may be related to dopamine, the chemical that carries signals among the nerve cells that control movement. Some research has shown that half of the time primary RLS can be traced to a family history. Secondary RLS only occurs as a result of an underlying medical condition such as iron deficiency, end-stage renal disease, pregnancy or diabetes. MIRAPEX is not indicated for the treatment of secondary RLS.

What are the symptoms of RLS?

Although RLS symptoms can vary from person to person, they are generally described as burning, creeping, crawling, aching, tingling, or tugging sensations in the legs. These sensations often occur in the lower legs, deep inside the leg. These sensations can also occur in the feet, thighs, trunk, and arms. The typical discomfort of RLS begins or intensifies when inactive (eg, lying down).

What is MIRAPEX?

MIRAPEX is a prescription medicine used in the treatment of moderate to severe primary RLS. MIRAPEX can also be used to treat Parkinson’s disease. Taking MIRAPEX for one condition does not mean you have or will develop the other. MIRAPEX has not been studied in children.

What important information about MIRAPEX should I know?

Taking MIRAPEX may cause side effects, including:

  • Feeling drowsy or falling asleep during daily activities such as driving
  • Feeling faint or dizzy when you stand up
  • Nausea
  • Headache

Some patients taking MIRAPEX may experience hallucinations (experiencing something that does not actually exist). Very few patients taking MIRAPEX for RLS reported hallucinations, as hallucinations are more common in patients taking MIRAPEX for Parkinson's disease (where it is prescribed in higher dosages). Be careful when taking drugs that can make you sleepy or when drinking alcohol while taking MIRAPEX for RLS.

What important things should I tell my doctor?

Before starting MIRAPEX, tell your doctor if:

  • You take other medicines (prescription or over-the-counter)
  • You drink alcohol. Drinking may increase your chances of becoming drowsy while taking MIRAPEX
  • You are pregnant, breastfeeding, or plan to become pregnant
  • You suffer from a sleep disorder other than RLS
  • You suffer from kidney disease
  • You are allergic to the active ingredient pramipexole, or to any of the inactive ingredients in MIRAPEX
  • You are having trouble controlling your muscles
  • You have low blood pressure or if you feel dizzy or faint, especially when getting up from a lying down or sitting position

When taking MIRAPEX, tell your doctor if:

  • You become unexpectedly sleepy
  • You feel dizzy, nauseated, sweaty, or faint—especially when you stand up after sitting or lying down

How is MIRAPEX taken to treat RLS?

Some key points about taking MIRAPEX:

  • Take MIRAPEX as your doctor directs. It is often recommended that MIRAPEX be taken once a day, 2 or 3 hours before bedtime
  • Take MIRAPEX every day — even if you do not feel RLS symptoms every day
  • MIRAPEX may be taken with or without food
  • If you miss a dose, DO NOT double your next dose. Take only your usual dose, as your doctor directs
  • Make it easy to remember. Find ways to make taking MIRAPEX part of your evening routine

What are the possible side effects of MIRAPEX?

Most people who take MIRAPEX tolerate it well. Some of the more common side effects can include

  • Nausea
  • Headache
  • Fatigue
  • Somnolence

When beginning to take MIRAPEX, you should be cautious until you know how the drug will affect you. Some people who take MIRAPEX can become sleepy or fall asleep while doing normal everyday activities like driving a car. It is possible that MIRAPEX treatment can cause someone to feel faint or become dizzy when standing up from a seated or prone position. There are reports of some people having hallucinations (experiencing something that does not actually exist) while taking MIRAPEX. However, hallucinations are uncommon in people taking MIRAPEX for primary RLS and occur more frequently in people over 65 taking MIRAPEX for Parkinson's disease.

There have been reports of patients taking certain medications to treat Parkinson’s disease or RLS, including MIRAPEX, that have reported problems with gambling, compulsive eating, and increased sex drive. It is not possible to reliably estimate how often these behaviors occur to determine which factors may contribute to them. If you or your family members notice that you are developing unusual behaviors, talk to your doctor.

Please note that we have not presented a complete list of possible side effects. Your doctor or pharmacist can give you further information. Likewise, it is important to talk to your doctor if you experience any of these problems.

How should I store MIRAPEX?

MIRAPEX should be kept in a tightly closed container out of the reach of children. Always store MIRAPEX at room temperature and away from direct sunlight.

IMPORTANT SAFETY INFORMATION ABOUT MIRAPEX: MIRAPEX tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).

MIRAPEX may cause you to fall asleep without any warning, even while doing normal daily activities, such as driving. When taking MIRAPEX, hallucinations may occur and sometimes you may feel dizzy, sweaty or nauseated upon standing up. The most common side effects in clinical trials for RLS were nausea, headache, and tiredness. You should talk with your doctor if you experience these problems.

Patients and caregivers should be informed that impulse control disorders/compulsive behaviors may occur while taking medicines, including pramipexole, to treat Parkinson's disease and RLS.

This information is intended for U.S. residents only. Products discussed herein may have different labeling in different countries.

Please see full Prescribing Information, including patient information.

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

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