Mirapex has some of the same effects as a chemical called dopamine, which occurs naturally in your body. Low levels of dopamine in the brain are associated with Parkinson's disease.

Mirapex is used to treat symptoms of Parkinson's disease, such as stiffness, tremors, muscle spasms, and poor muscle control. Mirapex is also used to treat restless legs syndrome (RLS).

Immediate-release tablet (Mirapex) is approved to treat either Parkinson symptoms or RLS. The extended-release tablet (Mirapex ER) is only approved to treat Parkinson symptoms.

Parkinson's and RLS are two separate disorders. Having one of these conditions will not cause you to have the other condition.

Some people taking Mirapex have fallen asleep during normal daytime activities such as working, talking, eating, or driving. You may fall asleep suddenly, even after feeling alert. Tell your doctor if you have any problems with daytime sleepiness or drowsiness. If you are unsure of how this medicine will affect you, be careful if you drive or do anything that requires you to be awake and alert.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking Mirapex. Talk with your doctor if you believe you have any intense or unusual urges while taking Mirapex.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

If you are taking Mirapex for rest leg syndrome (RLS), tell your doctor if your symptoms get worse, if they occur in the morning or earlier than usual in the evening, or if you feel restless symptoms in your hands or arms.

Before taking this medicine

You should not use Mirapex if you are allergic to pramipexole.

To make sure Mirapex is safe for you, tell your doctor if you have ever had:

• low blood pressure;

• dizziness after getting up too fast;

• daytime drowsiness;

• kidney disease; or

• problems controlling your muscle movements.

People with Parkinson's disease may have a higher risk of skin cancer (melanoma). Talk to your doctor about this risk and what skin symptoms to watch for.

FDA pregnancy category C. It is not known whether Mirapex will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

It is not known whether pramipexole passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Take Mirapex exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

If you are taking Mirapex you should not take extended-release Mirapex ER at the same time.

The dose and timing of Mirapex in treating Parkinson's disease is different from the dose and timing in treating RLS. Follow the directions on your prescription label. Ask your pharmacist if you have any questions about the kind of tablet you receive at the pharmacy.

Mirapex can be taken with or without food. Take the medication with food if it upsets your stomach.

Do not crush, chew, or break an extended-release Mirapex ER tablet. Swallow it whole.

If you are taking this medication for RLS, tell your doctor if your symptoms get worse, if they occur in the morning or earlier than usual in the evening, or if you feel restless symptoms in your hands or arms.

Do not stop using this medicine suddenly, or you could have unpleasant withdrawal symptoms. Follow your doctor's instructions about tapering your dose.

Store at room temperature away from moisture, heat, and light.

Usual Adult Dose for Parkinson's Disease:

Pramipexole immediate-release:
Initial dose: 0.125 mg orally three times a day with or without food.
Maintenance dose: The dosage should be titrated gradually to the desired clinical effect. Generally, the dosage may be increased every 5 to 7 days based on efficacy and tolerability, up to a maximum of 4.5 mg/day (given as 1.5 mg three times a day). The efficacy of dosages beyond 4.5 mg/day has not been established.

Pramipexole extended-release:
Initial dose: 0.375 mg once daily with or without food.
Maintenance dose: The dosage should be titrated gradually to the desired clinical effect. Generally, the dosage may be increased every 5 to 7 days based on efficacy and tolerability, first to 0.75 mg per day and then by 0.75 mg increments up to a maximum recommended dose of 4.5 mg per day. The efficacy of dosages beyond 4.5 mg/day has not been established.

Usual Adult Dose for Restless Legs Syndrome:

Pramipexole immediate-release:
Initial dose: 0.125 mg orally once a day 2 to 3 hours before bedtime. If needed, dose may be titrated upwards by increments of 0.125 mg every 4 to 7 days.
Maintenance dose: 0.5 mg orally once a day 2 to 3 hours before bedtime.

Pramipexole extended-release is not indicated for Restless Legs Syndrome.

You should not use Mirapex if you are allergic to pramipexole.

To make sure Mirapex is safe for you, tell your doctor if you have ever had:

• low blood pressure;

• dizziness after getting up too fast;

• daytime drowsiness;

• kidney disease; or

• problems controlling your muscle movements.

People with Parkinson's disease may have a higher risk of skin cancer (melanoma). Talk to your doctor about this risk and what skin symptoms to watch for.

FDA pregnancy category C. It is not known whether Mirapex will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

It is not known whether pramipexole passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Do not drink alcohol. Dangerous side effects can occur when alcohol is combined with Mirapex.

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Get emergency medical help if you have any signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Some people taking Mirapex have fallen asleep during normal daytime activities such as working, talking, eating, or driving. Tell your doctor if you have any problems with daytime sleepiness or drowsiness.

Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;

• hallucinations (seeing or hearing things that are not real);

• extreme drowsiness, falling asleep suddenly, even after feeling alert;

• tremors, twitching or uncontrollable muscle movements;

• unexplained muscle pain, tenderness, or weakness;

• vision problems; or

• posture changes you cannot control, such as involuntary bending forward of your neck, bending forward at the waist, or tilting sideways when you sit, stand, or walk.

Side effects such as confusion or hallucinations may be more likely in older adults.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking this medicine. Talk with your doctor if this occurs.

Common Mirapex side effects may include:

• muscle spasm or muscle weakness;

• drowsiness, dizziness, weakness;

• confusion, memory problems;

• dry mouth;

• nausea, constipation;

• increased urination; or

• sleep problems (insomnia), unusual dreams.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Using Mirapex with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Tell your doctor about all your current medicines and any you start or stop using, especially:

• cimetidine;

• metoclopramide; or

• medicine to treat mental illness, such as chlorpromazine, droperidol, fluphenazine, haloperidol, perphenazine, prochlorperazine, thioridazine, and others.

This list is not complete. Other drugs may interact with pramipexole, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed in this medication guide.