Pramipexole Oral Extended-release Tablet

What is this medication?

PRAMIPEXOLE (pra mi PEX ole) is used to treat symptoms of Parkinson's disease.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Mirapex ER

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• if you often drink alcohol
• heart disease
• kidney disease
• low blood pressure
• mental illness
• narcolepsy
• on hemodialysis
• sleep apnea
• an unusual or allergic reaction to pramipexole, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth with water. Take it as directed on the prescription label at the same time every day. You can take it with or without food. If it upsets your stomach, take it with food. Do not cut, crush or chew this medicine. Keep taking this medicine unless your health care provider tells you to stop. Stopping it too quickly can cause serious side effects. It can also make your condition worse.

Talk to your health care provider about the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose and it is no later than 12 hours after the normal time, take it as soon as you can. After 12 hours, skip the missed dose. Take your next dose at the normal time. Do not take extra or 2 doses at the same time.

What may interact with this medication?

• alcohol
• antihistamines for allergy, cough and cold
• certain medicines for depression, anxiety, or psychotic disturbances
• certain medicines for seizures like phenobarbital, primidone
• certain medicines for sleep
• general anesthetics like halothane, isoflurane, methoxyflurane, propofol
• medicines for blood pressure
• medicines that relax muscles for surgery
• metoclopramide
• narcotic medicines for pain

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your health care provider for regular checks on your progress. Tell your health care provider if your symptoms do not start to get better or if they get worse.

Do not suddenly stop taking this medicine. You may develop a severe reaction. Your health care provider will tell you how much medicine to take. If your health care provider wants you to stop the medicine, the dose may be slowly lowered over time to avoid any side effects.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this drug affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy and drinking plenty of water may help. Contact your health care provider if the problem does not go away or is severe.

When taking this medicine, you may fall asleep without notice. You may be doing activities like driving a car, talking, or eating. You may not feel drowsy before it happens. Contact your health care provider right away if this happens to you.

There have been reports of increased sexual urges or other strong urges such as gambling while taking this medicine. If you experience any of these while taking this medicine, you should report this to your health care provider as soon as possible.

Talk with your doctor if you have posture changes you cannot control. These may include your neck bending forward, your spine bending forward at the waist, or tilting sideways when you sit, stand, or walk.

If you notice a tablet shell or pieces of a tablet in your stool, contact your health care provider. Your medication may need to be changed.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• changes in emotions or moods
• changes in vision
• confusion
• depressed mood
• falling asleep during normal activities like driving
• hallucinations
• involuntary muscle contractions; difficulty swallowing; difficulty walking
• new or increased gambling urges, sexual urges, uncontrolled spending, binge or compulsive eating, or other urges
• new or worsening curve in the spine
• signs and symptoms of low blood pressure like dizziness; feeling faint or lightheaded; falls; unusually weak or tired
• uncontrollable movements of the arms, face, head, mouth, neck, or upper body

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• constipation
• drowsiness
• dry mouth
• nausea
• trouble sleeping

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature at 20 to 25 degrees C (68 to 77 degrees F). Protect from moisture. Get rid of any unused medicine after the expiration date.

To get rid of medicines that are no longer needed or have expired:

• Take the medicine to a medicine take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medicine, check the label or package insert to see if the medicine should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your health care provider. If it is safe to put it in the trash, take the medicine out of the container. Mix the medicine with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.