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:

• Alcohol or substance use disorder
• Kidney disease
• Lung or breathing disease
• Suicidal thoughts, plans, or attempt; a previous suicide attempt by you or a family member
• An unusual or allergic reaction to gabapentin, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

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
• Narcotic 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?

Tell your care team if your symptoms do not start to get better or if they get worse. Do not stop taking except on your care team's advice. You may develop a severe reaction if you do.

This medication may cause serious skin reactions. They can happen weeks to months after starting the medication. Contact your care team right away if you notice 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.

You may get drowsy, dizzy, or have blurred vision. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medication affects you. To reduce dizzy or fainting spells, do not sit or stand up quickly, especially if you are an older patient. Alcohol can increase drowsiness and dizziness.

Watch for new or worsening thoughts of suicide or depression. This includes sudden changes in mood, behaviors, or thoughts. These changes can happen at any time but are more common in the beginning of treatment or after a change in dose. Call your care team right away if you experience these thoughts or worsening depression.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water may help.

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.