Uses of Amantadine Extended-Release Tablets:

• It is used to treat side effects caused by some other drugs.
• 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 Amantadine Extended-Release Tablets?

• If you have an allergy to amantadine or any other part of this medicine (amantadine extended-release tablets).
• If you are allergic to this medicine (amantadine extended-release tablets); any part of this medicine (amantadine extended-release tablets); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have any of these health problems: Glaucoma or kidney disease.

This is not a list of all drugs or health problems that interact with this medicine (amantadine 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 (amantadine 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 Amantadine Extended-Release Tablets?

For all uses of this medicine (amantadine extended-release tablets):

• Tell all of your health care providers that you take this medicine (amantadine 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 or have clear eyesight until you see how this medicine (amantadine 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.
• Talk with your doctor before you use other drugs and natural products that slow your actions.
• Avoid drinking alcohol while taking this medicine (amantadine extended-release tablets).
• Heat stroke has happened in people taking this medicine (amantadine extended-release tablets). Be careful in hot weather and during physical activity.
• If you have kidney problems, talk with your doctor. Your dose may need to be changed based on how well your kidneys work. Deaths have happened in people with kidney problems whose dose was too high for their kidney function.
• 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 (amantadine 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 (amantadine extended-release tablets). Call your doctor right away if this happens or you feel very sleepy.
• Deadly overdoses have happened with this medicine (amantadine extended-release tablets) in adults and children. Keep away from children. Do not take more than you were told. If this drug is taken by accident, call your poison control center or get medical care right away.
• Neuroleptic malignant syndrome (NMS) is a very bad and sometimes deadly health problem that has happened when this medicine (amantadine extended-release tablets) was stopped all of a sudden. NMS has also happened when the dose of this medicine (amantadine extended-release tablets) was lowered. Call your doctor right away if you have any fever, muscle cramps or stiffness, dizziness, very bad headache, confusion, change in thinking, fast heartbeat, heartbeat that does not feel normal, or are sweating a lot.
• If you are 65 or older, use this medicine (amantadine extended-release tablets) with care. You could have more side effects.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

Parkinson's disease:

• Increase your physical activity slowly as your Parkinson's disease symptoms improve.
• Do not stop taking this medicine (amantadine 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 (amantadine extended-release tablets), you will want to slowly stop it as ordered by your doctor.
• The chance of a type of skin cancer called melanoma may be raised in people with Parkinson's disease. It is not known if this medicine (amantadine extended-release tablets) may also raise the chance. Have skin exams while you take this medicine (amantadine extended-release tablets). Talk with your doctor.

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

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

• Take with or without food.
• Take in the morning if taking once a day.
• Swallow whole. Do not chew, break, or crush.
• Keep taking this medicine (amantadine extended-release tablets) as you have been told by your doctor or other health care provider, even if you feel well.
• Talk with your doctor before getting a flu vaccine after taking this medicine (amantadine extended-release tablets). Talk with your doctor before you take this medicine (amantadine extended-release tablets) if you have just gotten a flu vaccine.

What do I do if I miss a dose?

• Skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

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:

For all uses of this medicine (amantadine extended-release tablets):

• 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.
• Very bad dizziness or passing out.
• New or worse behavior or mood changes like depression or thoughts of suicide.
• Feeling confused.
• Hallucinations (seeing or hearing things that are not there).
• Seizures.
• Shortness of breath, a big weight gain, or swelling in the arms or legs.
• Trouble passing urine.
• Blurred eyesight.
• Strong urges that are hard to control (such as eating, gambling, sex, or spending money).
• Change in balance.
• Falls.

Parkinson's disease:

• A skin lump or growth.
• Change in color or size of a mole.

What are some other side effects of Amantadine 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:

• Upset stomach.
• Trouble sleeping.
• Feeling dizzy, sleepy, tired, or weak.
• Headache.
• Dry mouth.
• Diarrhea or constipation.
• Not hungry.
• Anxiety.
• Strange or odd dreams.
• Dry nose.
• You may see something that looks like the tablet in your stool. This is normal and not a cause for concern. If you have questions, talk with your doctor.

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 Amantadine Extended-Release Tablets?

• Store at room temperature.
• 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 (amantadine 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.

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