Pramipexole Extended-Release Tablets

What is this medication?

PRAMIPEXOLE (pra mi PEX ole) treats the symptoms of Parkinson disease. It works by acting like dopamine, a substance in your body which helps manage movements and coordination. This reduces the symptoms of Parkinson, such as body stiffness and tremors.

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:

• Frequently drink alcohol
• Heart disease
• Kidney disease
• Low blood pressure
• Mental health condition
• Narcolepsy
• On hemodialysis
• Sleep apnea
• An unusual or allergic reaction to pramipexole, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication 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 medication. Swallow tablets whole. Keep taking this medication unless your care team tells you to stop. Stopping it too quickly can cause serious side effects. It can also make your condition worse.

Talk to your care team about the use of this medication 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 medications for depression, anxiety, or mental health conditions
• Certain medications for seizures, such as phenobarbital, primidone
• Certain medications for sleep
• General anesthetics, such as halothane, isoflurane, methoxyflurane, propofol
• Medications for blood pressure
• Medications that relax muscles for surgery
• Metoclopramide
• Opioid medications 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 care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

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

This medication may affect your coordination, reaction time, or judgement. Do not drive or operate machinery until you know how this medication affects you. Sit up or stand slowly to reduce the risk of dizzy or fainting spells. Drinking alcohol with this medication can increase the risk of these side effects.

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

When taking this medication, you may fall asleep without notice. You may be doing activities, such as driving a car, talking, or eating. You may not feel drowsy before it happens. Contact your care team 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 medication. If you experience any of these while taking this medication, you should report this to your care team as soon as possible.

Talk with your care team 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 care team. 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 care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Falling asleep during daily activities
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Low blood pressure—dizziness, feeling faint or lightheaded, blurry vision
• Hallucinations
• Mood swings, irritability, hostility
• Muscle injury—unusual weakness or fatigue, muscle pain, dark yellow or brown urine, decrease in amount of urine
• New or worsening uncontrolled and repetitive movements of the face, mouth, or upper body
• Urges to engage in impulsive behaviors such as gambling, binge eating, sexual activity, or shopping in ways that are unusual for you.

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

• Confusion
• Constipation
• Dizziness
• Drowsiness
• Dry mouth
• Headache
• 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 medication after the expiration date.

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

• Take the medication to a take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix the medication 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.