Uses of Gabapentin Enacarbil:

• It is used to treat restless leg syndrome.
• 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 Gabapentin Enacarbil?

• If you are allergic to gabapentin enacarbil; any part of gabapentin enacarbil; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have restless leg syndrome and you need to sleep during the daytime and stay awake at night.
• If you are on dialysis, talk with your doctor.
• 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 gabapentin enacarbil.

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 gabapentin enacarbil 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 Gabapentin Enacarbil?

• Tell all of your health care providers that you take gabapentin enacarbil. 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 gabapentin enacarbil affects you.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Avoid drinking alcohol while taking gabapentin enacarbil.
• Talk with your doctor before you use other drugs and natural products that slow your actions.
• This medicine is not the same as gabapentin (Gralise™, Neurontin®). Do not use in its place. Talk with your doctor.
• Do not stop taking gabapentin enacarbil all of a sudden without calling your doctor. You may have a greater risk of side effects. If you need to stop gabapentin enacarbil, you will want to slowly stop it as ordered by your doctor.
• A severe and sometimes deadly reaction has happened. Most of the time, this reaction has signs like fever, rash, or swollen glands with problems in body organs like the liver, kidney, blood, heart, muscles and joints, or lungs. If you have questions, talk with the doctor.
• 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 gabapentin enacarbil 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.

How is this medicine (Gabapentin Enacarbil) best taken?

Use gabapentin enacarbil as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take gabapentin enacarbil with food.
• Swallow whole. Do not chew, break, or crush.
• For restless leg syndrome, take about 5 PM each day.

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:

• 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.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• Feeling confused.
• 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.
• Muscle pain or weakness.
• Blurred eyesight.
• Chest pain or pressure.
• Shortness of breath, a big weight gain, or swelling in the arms or legs.
• Fever, chills, or sore throat; any unexplained bruising or bleeding; or feeling very tired or weak.
• Swollen gland.
• 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 gabapentin enacarbil 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.

What are some other side effects of Gabapentin Enacarbil?

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.
• Headache.
• Upset stomach.
• Trouble sleeping.
• Weight gain.

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 Gabapentin Enacarbil?

• Store at room temperature in a dry place. Do not store in a bathroom.
• Store in the original container. Do not take out the antimoisture cube or packet.
• 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 gabapentin enacarbil, 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.