Uses of Pregabalin Extended-Release Tablets:

• It is used to treat painful nerve diseases.
• It may be given to you for other reasons. Talk with the doctor.

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

• If you are allergic to this medicine (pregabalin extended-release tablets); any part of this medicine (pregabalin 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 breast-feeding. Do not breast-feed while you take this medicine (pregabalin extended-release tablets).

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

• Tell all of your health care providers that you take this medicine (pregabalin 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 (pregabalin extended-release tablets) affects you.
• Do not stop taking this medicine (pregabalin 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 (pregabalin extended-release tablets), you will want to slowly stop it as ordered by your doctor.
• Avoid drinking alcohol while taking this medicine (pregabalin extended-release tablets).
• Talk with your doctor before you use other drugs and natural products that slow your actions.
• A very bad reaction called angioedema has happened with this medicine (pregabalin extended-release tablets). Sometimes, this may be life-threatening. Signs may include swelling of the hands, face, lips, eyes, tongue, or throat; trouble breathing; trouble swallowing; or unusual hoarseness. Get medical help right away if you have any of these signs.
• Severe breathing problems have happened. Sometimes, this has been deadly. The risk may be greater in people taking certain drugs like opioid pain drugs or those with certain health problems like chronic obstructive pulmonary disease (COPD). The risk may also be greater in people who are older than 65. If you have questions, talk with the doctor.
• If you are 65 or older, use this medicine (pregabalin extended-release tablets) with care. You could have more side effects.
• Talk with your doctor if you plan to father a child. This medicine made male animals less fertile and caused sperm changes. Birth defects also happened in the young of male animals treated with this medicine (pregabalin extended-release tablets). It is not known if these problems happen in humans.
• 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 (pregabalin extended-release tablets) while you are pregnant.

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

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

• Take after the evening meal if taking once daily.
• Swallow whole. Do not chew, break, or crush.
• Keep taking this medicine (pregabalin extended-release tablets) as you have been told by your doctor or other health care provider, even if you feel well.

What do I do if I miss a dose?

• Take a missed dose just before bedtime after eating a snack or after the next day's morning meal.
• If you miss taking the missed dose after the next day's morning meal, 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:

• 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.
• Change in eyesight.
• Muscle pain or weakness.
• If seizures are new or worse after starting this medicine (pregabalin extended-release tablets).
• Change in balance.
• Feeling confused.
• Shakiness.
• Trouble breathing, slow breathing, or shallow breathing.
• Change in color of skin to a bluish color like on the lips, nail beds, fingers, or toes.
• Memory problems or loss.
• Shortness of breath, a big weight gain, or swelling in the arms or legs.
• Fast or abnormal heartbeat.
• Fever, chills, or sore throat.
• Skin sores.
• Trouble speaking.
• Trouble sleeping.
• Trouble walking.
• Feeling high (easy laughing and feeling good).
• Twitching.
• Get medical help right away if you feel very sleepy, very dizzy, or if you pass out. Caregivers or others need to get medical help right away if the patient does not respond, does not answer or react like normal, or will not wake up.
• Patients who take this medicine (pregabalin extended-release tablets) may be at a greater risk of having thoughts or actions of suicide. The risk may be greater in people who have had these thoughts or actions in the past. Call the doctor right away if signs like low mood (depression), nervousness, restlessness, grouchiness, panic attacks, or changes in mood or actions are new or worse. Call the doctor right away if any thoughts or actions of suicide occur.
• Low platelet counts have rarely happened with this medicine (pregabalin extended-release tablets). This may lead to a higher chance of bleeding. Call your doctor right away if you have any unexplained bruising or bleeding.

What are some other side effects of Pregabalin 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:

• Feeling dizzy, sleepy, tired, or weak.
• Weight gain.
• Not able to focus.
• Headache.
• Dry mouth.
• Constipation.
• More hungry.
• Upset stomach.
• Joint pain.
• Nose or throat irritation.

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 Pregabalin Extended-Release Tablets?

• Store in the original container 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.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this medicine (pregabalin extended-release tablets) is refilled. If you have any questions about this medicine (pregabalin extended-release tablets), please talk with the doctor, 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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