When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to pramipexole.

How to Use This Medicine:
Tablet, Long Acting Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• You may take this medicine with or without food. Taking this medicine with food may help reduce nausea.
• Swallow the extended-release tablet whole. Do not crush, break, or chew it.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose:
  
  • Regular tablet: Skip the missed dose, and take your next dose as usual. Do not take extra medicine to make up for a missed dose.
  • Extended-release tablet: If it is less than 12 hours since your missed dose, take the missed dose as soon as you remember and take your next dose at the normal time. If it is more than 12 hours since your missed dose, skip the missed dose and take your next dose at the normal time.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

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

• Some medicines can affect how pramipexole works. Tell your doctor if you are using the following:
  
  • amantadine, cimetidine, diltiazem, levodopa, metoclopramide, quinidine, quinine, ranitidine, thiothixene, triamterene, or verapamil
  • a phenothiazine medicine (such as chlorpromazine, perphenazine, promethazine, prochlorperazine, thioridazine)
• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol.
• Tell your doctor if you are using any medicine that makes you sleepy, such as allergy medicine or narcotic pain medicine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, low blood pressure, a sleep disorder, or dyskinesia (trouble with muscle control).
• This medicine may cause the following problems:
  
  • Low blood pressure
  • Hallucinations
  • Urges to gamble, spend money, binge eat, have sex, or engage in other compulsive behaviors
  • An increased risk for skin cancer
• This medicine may make you dizzy or drowsy. It may even cause you to fall asleep without warning while you drive, talk, or eat. Do not drive or do anything that could be dangerous until you know how this medicine affects you. Stand up slowly if you feel dizzy or lightheaded.
• Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

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 or trouble breathing
• Extreme sleepiness or drowsiness
• Lightheadedness, dizziness, or fainting
• Muscle pain, stiffness, tenderness, or weakness
• Seeing, hearing, or feeling things that are not really there
• Twitching or muscle movements you cannot control, tremors, problems with balance or walking

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

• Constipation or nausea
• Dry mouth
• Headache, confusion, memory problems, or unusual behavior
• Unusual dreams

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