Pramipexole (By mouth)

Introduction

Pramipexole (pram-i-PEX-ole)

Treats Parkinson's disease. Also treats Restless Legs Syndrome (RLS).

Brand Name(s)

Mirapex, Mirapex ER

When This Medicine Should Not Be Used

How to Use This Medicine

Tablet, Long Acting Tablet

• Your doctor will tell you how much of this medicine to use and how often. Your dose may need to be changed several times in order to find out what works best for you. Do not use more medicine or use it more often than your doctor tells you to.
• You may take this medicine with or without food. Taking this medicine with food may lower your chances of getting nausea.
• Swallow the extended-release tablet whole. Do not crush, break, or chew it.
• The dose of this medicine is different depending on whether you have Parkinson's disease or RLS. People who have Parkinson's usually take more medicine. Make sure you understand how much to take.
• Read the Patient Information leaflet before you take this medicine and each time you get your prescription refilled. Ask your doctor if you have any questions.

If a dose is missed:

• If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you plan to become pregnant. Tell your doctor if you have kidney disease, low blood pressure, eye problem, lung disease, sleep disorder, history of skin cancer, or dyskinesia (trouble controlling your muscles).
• Do not stop using this medicine suddenly without asking your doctor. You may need to slowly decrease your dose before stopping it completely.
• This medicine may make you dizzy or drowsy, and you may suddenly fall asleep. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert. You may also feel lightheaded when standing suddenly from a sitting or lying position, so get up slowly.
• Some people who have used this medicine had hallucinations or unusual changes in their behavior, such as having problems with gambling, increased sex drive, or compulsive eating. Talk with your doctor if this is a concern for you.
• Your doctor will need to check your progress at regular visits while you are using this medicine. Your doctor may also need to check your skin regularly. Be sure to keep all appointments.
• It is important that your doctor check your skin for melanoma (tumor) regularly if you have Parkinson's disease.
• If your symptoms do not improve or if they get worse, call your doctor.For RLS, the symptoms might get worse in the early morning or start earlier in the afternoon. For Parkinson's, you might have new or worse muscle movements.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Change in how much or how often you urinate, or painful urination.
• Changes in vision.
• Chest pain.
• Extreme sleepiness or drowsiness.
• Fever, chills, cough, sore throat, and body aches.
• Lightheadedness, dizziness, or fainting.
• Muscle pain, stiffness, tenderness, or weakness.
• Problems with balance or walking.
• Seeing, hearing, or feeling things that are not really there.
• Swelling in your hands, ankles, or feet.
• Tremors.
• Trouble breathing.
• Twitching or muscle movements you cannot control.
• Unusual tiredness or weakness.

If you notice these less serious side effects, talk with your doctor:

• Changes in appetite.
• Constipation, diarrhea, nausea, or upset stomach.
• Dry mouth.
• Headache, confusion, memory problems, or unusual behavior.
• Increased appetite for food or sex.
• Pain in arms or legs.
• Problems having sex.
• Runny or stuffy nose.
• Skin rash or itching.
• Sleepiness, trouble sleeping, or unusual dreams.
• Weight changes.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are also taking amantadine (Symmetrel®), cimetidine (Tagamet®), diltiazem (Cardizem®), haloperidol (Haldol®), levodopa (Sinemet®), metoclopramide (Reglan®), ranitidine (Zantac®), thiothixene (Navane®), triamterene (Diazide®, Maxzide®), verapamil (Calan®, Covera®, Isoptin®, Verelan®), quinidine, quinine (Quinamin®), or a phenothiazine medicine (such as prochlorperazine, Compazine®, Mellaril®, Phenergan®, Thorazine®, or Trilafon®).
• Tell your doctor if you are using any medicines that make you sleepy. These include sleeping pills, cold and allergy medicine, narcotic pain relievers, and sedatives.
• Do not drink alcohol while you are using this medicine.