Generic Name: pramipexole (pram-i-PEX-ole)

Brand Names: Mirapex®

Classification: Non-Ergoline Dopamine Agonist

Issue Date: 1995

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). Mirapex is also being used to treat individuals with FM/CFS/ME.

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.

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 Mirapex without first talking to your doctor. You may need to use less and less before you stop the medication completely.

Dizziness or drowsiness may be more likely to occur when you rise from a sitting or lying position. Rise slowly and use caution to prevent a fall.

Avoid using other medicines that make you sleepy such as:

• alcohol
• cold medicine
• pain medication
• muscle relaxers
• medicine for seizures, depression or anxiety

They can add to sleepiness caused by Mirapex.

Avoid drinking alcohol, which can increase some of the side effects of Mirapex. Mirapex may cause hallucinations (the sensation of hearing or seeing something that is not there), most commonly among elderly people. Call your doctor if you have hallucinations.

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Your doctor may occasionally change your dose to make sure you get the best results from this medication.

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.

Take each dose with a full glass of water. Mirapex can be taken with or without food. Take the medication with food if it upsets your stomach.

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 Mirapex without first talking to your doctor. You may need to use less and less before you stop the medication completely.

Do not use this medication if you are allergic to Mirapex.

Before using Mirapex, tell your doctor if you are allergic to any drugs, or if you have:

• narcolepsy (a sleep disorder)
• kidney disease
• tremors (dyskinesia) or uncontrolled muscle movements

If you have any of these conditions, you may not be able to use Mirapex, or you may need a dosage adjustment or special tests during treatment.

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.

This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Mirapex may pass into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Mirapex may cause hallucinations (the sensation of hearing or seeing something that is not there), most commonly among elderly people. Call your doctor if you have hallucinations.

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction:

• skin rash or hives
• difficulty breathing
• swelling of your face, lips, tongue, or throat

Stop taking Mirapex and call your doctor at once if you have any of these serious side effects:

• extreme drowsiness, falling asleep suddenly, even after feeling alert
• hallucinations
• fever
• stiff muscles
• confusion
• sweating
• fast or uneven heartbeats
• nausea
• feeling light-headed
• fainting
• restless muscle movements in your eyes, tongue, jaw, or neck

Continue taking Mirapex if you have any of these less serious side effects:

• constipation
• upset stomach
• loss of appetite
• dry mouth
• trouble swallowing
• urinating more often than usual
• mild drowsiness or sleepiness
• sleep problems (insomnia)
• unusual dreams
• amnesia, forgetfulness
• thinking problems
• headache
• confusion
• weakness
• blurred vision
• joint pain, muscle weakness
• swelling in your hands or feet
• runny or stuffy nose
• weight loss
• impotence, loss of interest in sex, or trouble having an orgasm

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

Before taking Mirapex, tell your doctor if you are using any of the following drugs:

• amantadine (Symmetrel®)
• cimetidine (Tagamet®)
• diltiazem (Cardizem®, Cartia®, Dilacor®, Tiazac®)
• ranitidine (Zantac®)
• quinidine (Quinaglute®, Quinidex®)
• quinine(Qualaquin®)
• triamterine (Dyrenium®)
• verapamil (Calan®, Covera®, Isoptin®)

If you are using any of these drugs, you may not be able to use Mirapex, or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect Mirapex. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.