Gabapentin Enacarbil, Extended Release Oral

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KEY POINTS

• This medicine is taken by mouth to treat restless legs syndrome or postherpetic neuralgia. Take it exactly as directed.
• This medicine may increase suicidal thoughts or actions in some people.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antiseizure; analgesic

Generic and brand names: gabapentin enacarbil extended release, oral; Horizant

What is this medicine used for?

This medicine is taken by mouth to treat moderate to severe restless legs syndrome (RLS) and postherpetic neuralgia (nerve pain after you have had shingles).

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Depression, mood problems, or thoughts of suicide
• Kidney disease
• Problems with drug or alcohol abuse
• Seizures

Females of childbearing age: Talk with your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I take it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Check the label on the medicine for directions about your specific dose. Your healthcare provider may need to adjust your dosage. Take this medicine exactly as directed by your healthcare provider. Do not take more than directed. Do not stop taking it without your healthcare provider's approval. You need to gradually reduce your dosage to prevent side effects.

Check with your healthcare provider before using this medicine in children under age 18.

Take this medicine with food. Swallow the tablets whole. Do not split, crush, or chew them.

This medicine is not the same as other gabapentin medicines and should not be used in their place. Talk with your healthcare provider about this.

What if I miss a dose?

If you miss a dose, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: double vision, drowsiness, dizziness, slurred speech, diarrhea, lack of coordination, trouble breathing.

What should I watch out for?

This kind of medicine may increase suicidal thoughts or actions in some people. Contact your provider right away if you or your family notice any disturbing changes in your thoughts or behavior, such as:

• More outgoing or aggressive behavior than normal
• Confusion
• Restlessness
• Panic attacks
• New or worsening depression
• Suicidal thoughts

This medicine may make you drowsy or dizzy. This medicine may continue to make you drowsy even on the day after you take it. Do not drive or operate machinery unless you are fully alert. If you need to stay awake at night, ask your provider what time you should take this medicine.

Avoid alcohol and other medicines that slow down your nervous system (such as antihistamines and sleeping pills) while taking this medicine. Do not take any other medicines unless your healthcare provider approves them.

Your healthcare provider will want to check you regularly to see how this medicine affects you. Keep all appointments.

Adults over the age of 65 may be at greater risk for side effects. Talk with your healthcare provider about this.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; chest pain or tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Severe or continuous drowsiness or dizziness; fever; sore throat; swollen glands; trouble urinating or decreased urinating; yellowing of your skin or eyes; unusual tiredness or weakness; unusual bruising or bleeding; skin rash; severe muscle pain; unexplained swelling of hands or feet; unusual behavior or mood changes; new or worsening depression; thoughts of suicide; loss of coordination; vision changes.

Other: Drowsiness, dizziness, headache, gas, nausea, dry mouth; increased appetite; trouble sleeping.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Antianxiety medicines such as alprazolam (Xanax), clonazepam (Klonopin), clorazepate (Gen-Xene, Tranxene), diazepam (Valium), lorazepam (Ativan), and oxazepam
• Antidepressants such as amitriptyline, clomipramine, desipramine (Norpramin), desvenlafaxine (Pristiq), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), imipramine (Tofranil), nefazodone, nortriptyline (Pamelor), sertraline (Zoloft), and trazodone, and venlafaxine (Effexor)
• Antihistamines such as chlorpheniramine (Chlor-Trimeton), clemastine (Tavist), and diphenhydramine (Benadryl)
• Antipsychotic medicines such as aripiprazole (Abilify), asenapine (Saphris), brexpiprazole (Rexulti), chlorpromazine, clozapine (Clozaril, FazaClo), fluphenazine, haloperidol (Haldol), olanzapine (Zyprexa), perphenazine, quetiapine (Seroquel), risperidone (Risperdal), thioridazine, trifluoperazine, and ziprasidone (Geodon)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), ezogabine (Potiga), felbamate (Felbatol), lamotrigine (Lamictal), levetiracetam (Keppra), phenytoin (Dilantin, Phenytek), primidone (Mysoline), tiagabine (Gabitril), and topiramate (Qudexy, Topamax, Trokendi)
• Cimetidine (Tagamet)
• Doxepin (Silenor)
• Milnacipran (Savella)
• Muscle relaxants such as baclofen (Gablofen, Lioresal), carisoprodol (Soma), cyclobenzaprine (Amrix), dantrolene (Dantrium), methocarbamol (Robaxin), and tizanidine (Zanaflex)
• Narcotic pain medicines such as codeine, fentanyl (Abstral, Actiq, Duragesic, Fentora, Sublimaze), hydrocodone/acetaminophen (Norco, Vicodin), hydromorphone (Dilaudid, Exalgo), meperidine (Demerol), methadone (Dolophine, Methadose), morphine (Kadian, MS Contin), oxycodone (OxyContin, Roxicodone), and oxycodone/acetaminophen (Percocet, Roxicet)
• Natural remedies such as evening primrose, gotu kola, kava, St. John's wort, and valerian
• Nausea medicines such as prochlorperazine (Compro) and promethazine
• Other medicines that contain gabapentin
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Sleeping pills such as butabarbital (Butisol), phenobarbital, triazolam (Halcion), zaleplon (Sonata), and zolpidem (Ambien, Edluar, Intermezzo)

Do not drink alcohol unless your healthcare provider approves.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature in the original bottle. Keep the container tightly closed. Do not remove any moisture control packs that come in the bottle. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.