Uses of Pramipexole Extended-Release Tablets:

• It is used to treat Parkinson's disease.
• It may be given to you for other reasons. Talk with the doctor.

What do I need to tell my doctor BEFORE I take Pramipexole Extended-Release Tablets?

• If you have an allergy to pramipexole or any other part of this medicine (pramipexole extended-release tablets).
• If you are allergic to this medicine (pramipexole extended-release tablets); any part of this medicine (pramipexole extended-release tablets); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have kidney disease.
• If you are taking another drug that has the same drug in it.

This is not a list of all drugs or health problems that interact with this medicine (pramipexole extended-release tablets).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine (pramipexole extended-release tablets) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Pramipexole Extended-Release Tablets?

All products:

• Tell all of your health care providers that you take this medicine (pramipexole extended-release tablets). This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how this medicine (pramipexole extended-release tablets) affects you.
• To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
• Check your blood pressure as you have been told.
• Do not stop taking this medicine (pramipexole extended-release tablets) all of a sudden without calling your doctor. You may have a greater risk of side effects. If you need to stop this medicine (pramipexole extended-release tablets), you will want to slowly stop it as ordered by your doctor.
• Avoid drinking alcohol while taking this medicine (pramipexole extended-release tablets).
• Talk with your doctor before you use other drugs and natural products that slow your actions.
• If you are 65 or older, use this medicine (pramipexole extended-release tablets) with care. You could have more side effects.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine (pramipexole extended-release tablets) while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.
• You may see something that looks like the tablet in your stool. If this happens, talk with your doctor.

How is this medicine (Pramipexole Extended-Release Tablets) best taken?

Use this medicine (pramipexole extended-release tablets) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food. Take with food if it causes an upset stomach.
• Keep taking this medicine (pramipexole extended-release tablets) as you have been told by your doctor or other health care provider, even if you feel well.
• Swallow whole. Do not chew, break, or crush.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it has been 12 hours or more since the missed dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.
• If you miss taking this medicine (pramipexole extended-release tablets) for a few days in a row, call your doctor before you start taking it again.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Strong urges that are hard to control (such as eating, gambling, sex, or spending money).
• Fever.
• Feeling confused.
• Muscle stiffness.
• Passing urine more often.
• Very bad dizziness or passing out.
• Sweating a lot.
• Shortness of breath, a big weight gain, or swelling in the arms or legs.
• Change in eyesight.
• Trouble controlling body movements that is new or worse.
• Trouble moving around.
• Hallucinations (seeing or hearing things that are not there).
• Memory problems or loss.
• Muscle pain or weakness.
• Mental, mood, or behavior changes that are new or worse.
• Some people have fallen asleep during activities like driving, eating, or talking. Some people did not feel sleepy and felt alert right before falling asleep. This has happened up to 1 year after this medicine (pramipexole extended-release tablets) was started. If you fall asleep during activities, do not drive or do other tasks or actions that call for you to be alert while you take this medicine (pramipexole extended-release tablets). Call your doctor right away if this happens or you feel very sleepy.
• Some people have had changes in posture that cannot be controlled. These may include neck bending forward, bending forward at the waist, or tilting sideways when you sit, stand, or walk. Changes in posture may happen several months after you start this medicine (pramipexole extended-release tablets) or after an increase in dose. Call your doctor if you have any changes in posture.

Restless leg syndrome:

• For restless leg syndrome, tell your doctor if your signs become worse or start earlier in the day.

What are some other side effects of Pramipexole Extended-Release Tablets?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Upset stomach.
• Constipation.
• Not able to sleep.
• Dizziness.
• Feeling sleepy.
• Dry mouth.
• Feeling tired or weak.
• Strange or odd dreams.
• Diarrhea.
• Muscle spasm.
• Weight loss.
• Stuffy nose.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Pramipexole Extended-Release Tablets?

• Store at room temperature.
• Protect from light.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine (pramipexole extended-release tablets), please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.