Gabapentin Enacarbil Extended-Release Tablets

What is this medication?

GABAPENTIN (GA ba pen tin) treats nerve pain. It may also be used to treat restless legs syndrome (RLS). It works by calming overactive nerves in your body.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Horizant

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Have or have had depression
• Kidney disease
• Lung or breathing disease, such as asthma or COPD
• Substance use disorder
• Suicidal thoughts, plans, or attempt
• An unusual or allergic reaction to gabapentin, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

Take this medication by mouth with a glass of water. Follow the directions on the prescription label. Take this medication with food. Do not cut, crush, or chew this medication. Take your medication at regular intervals. Do not take it more often than directed. Do not stop taking except on your care team's advice.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

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, wait and take the next dose at your regular time. Do not take double or extra doses.

What may interact with this medication?

• Alcohol
• Antihistamines for allergy, cough, and cold
• Certain medications for anxiety or sleep
• Certain medications for depression like amitriptyline, fluoxetine, sertraline
• Certain medications for seizures like phenobarbital, primidone
• Certain medications for stomach problems
• General anesthetics like halothane, isoflurane, methoxyflurane, propofol
• Local anesthetics like lidocaine, pramoxine, tetracaine
• Medications that relax muscles for surgery
• Opioid medications for pain
• Phenothiazines like chlorpromazine, mesoridazine, prochlorperazine, thioridazine

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 judgment. 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.

Taking this medication with other CNS depressants can make you too sleepy. This can make it hard to breathe and stay awake. In some cases, it can cause coma and death. CNS depressants include opioids, benzodiazepines, muscle relaxants, medications for sleep, and alcohol. Talk to your care team about all the medications, vitamins, and supplements you take. They can tell you what is safe to take together. Call emergency services right away if you have slow or shallow breathing, feel dizzy or confused, or have trouble staying awake.

This medication can cause new or worsening depression and increase the risk of suicidal thoughts and actions in a small number of people. This can happen while you are taking this medication or after stopping it. Talk to your care team right away if you have changes in mood or behavior or thoughts of self-harm or suicide. They can help you.

This medication may cause serious skin reactions. They can happen weeks to months after starting the medication. Talk to your care team right away if you have fevers or flu-like symptoms with a rash. The rash may be red or purple and then turn into blisters or peeling of the skin. Or you might notice a red rash with swelling of the face, lips, or lymph nodes in your neck or under your arms.

Talk to your care team if you may be pregnant. There are benefits and risks to taking medications during pregnancy. Your care team can help you find the option that works for you.

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 or angioedema—skin rash, itching, hives, swelling of the face, eyes, lips, tongue, arms, or legs, trouble swallowing or breathing
• Rash, fever, and swollen lymph nodes
• Thoughts of suicide or self harm, worsening mood, feelings of depression
• Trouble breathing

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

• Dizziness
• Drowsiness
• Headache

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 between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medication after the expiration date. Keep this medication dry and away from moisture.

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.