Pramipexole oral extended-release tablet

What is this medicine?

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

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. 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. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking this medicine suddenly except upon the advice of your doctor. Stopping this medicine too quickly may cause side effects or your condition may worsen.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

What side effects may I notice from receiving this medicine?

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

• 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

What may interact with this medicine?

• 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

What if I miss a dose?

If you miss a dose, skip the dose you missed. Take the next dose at your regular time. Do not take double or extra doses.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F) . Protect from moisture. Throw away any unused medicine after the expiration date.

What should I tell my health care provider before I take this medicine?

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

What should I watch for while using this medicine?

Visit your health care professional for regular checks on your progress. Tell your health care professional if your symptoms do not start to get better or if they get worse. Do not stop taking except on your health care professional's advice. You may develop a severe reaction. Your health care professional will tell you how much medicine to take.

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 professional 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.

Some patients notice a tablet residue, which may resemble a tablet or pieces of a tablet, in their stool. If this occurs, contact your health care provider. Your medication may need to be changed. Do not stop your medicine except on the advice of your health care provider.