Gabapentin, Extended Release Oral

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KEY POINTS

• This medicine is taken by mouth to relieve pain from shingles.
• This medicine may increase suicidal thoughts or actions in some people.
• 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: analgesic; antiseizure

Generic and brand names: gabapentin extended release, oral; Gralise

What is this medicine used for?

This medicine is taken by mouth to relieve pain from damaged nerves caused by herpes zoster (shingles) in adults.

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 or thoughts of suicide
• Kidney disease
• 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 will adjust your dosage until you receive maximum benefit with minimum risk. Take this medicine exactly as directed by your healthcare provider. 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 your evening meal. Swallow the tablets whole. Do not split, crush, or chew them. If you take an antacid, take this medicine 2 hours after you take the antacid.

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, take it (with food) as soon as you remember unless it is almost time for the next scheduled dose. In that case, 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, 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 cause serious side effects that can affect your liver or kidneys. Contact your healthcare provider right away if you have a fever or rash, yellowing of the skin or eyes, dark urine, severe stomach pain, loss of appetite, unusual tiredness, unusual bruising or bleeding, or trouble urinating.

This medicine may make you drowsy or dizzy. Do not drive or operate machinery unless you are fully alert.

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

Adults over the age of 65 may be at greater risk for side effects.

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; loss of coordination; unusual behavior or mood changes; new or worsening depression; thoughts of suicide; fever; swollen glands; blurred vision; irregular heartbeat; trouble urinating; loss of coordination; yellowing of your skin or eyes; unusual tiredness or weakness; loss of appetite; trouble concentrating; unusual bruising or bleeding; skin rash, redness, blisters, or peeling; muscle or joint pain; severe stomach pain.

Other: Drowsiness; dizziness; tremors; nervousness; swelling of hands or feet; nausea; vomiting; diarrhea; constipation; gas; dry mouth; heartburn; headache; back pain.

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:

• Antacids that contain aluminum or magnesium, such as Gaviscon, Maalox, and Mylanta (Take this medicine at least 2 hours after you take an antacid.)
• Antianxiety medicines such as alprazolam (Xanax), clonazepam (Klonopin), clorazepate (Gen-Xene, Tranxene), diazepam (Valium), lorazepam (Ativan), and oxazepam
• Antidepressants such as amitriptyline, duloxetine (Cymbalta), fluoxetine (Prozac), imipramine (Tofranil), nortriptyline (Pamelor), sertraline (Zoloft), and trazodone
• Antihistamines such as azelastine (Astelin, Astepro), chlorpheniramine (Chlor-Trimeton), clemastine (Tavist), and diphenhydramine (Benadryl)
• Antipsychotic medicines such as chlorpromazine, clozapine (Clozaril, FazaClo), fluphenazine, haloperidol (Haldol), olanzapine (Zyprexa), perphenazine, thioridazine, and trifluoperazine
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), clobazam (Onfi), eslicarbazepine (Aptiom), ethosuximide (Zarontin), felbamate (Felbatol), fosphenytoin (Cerebyx), lamotrigine (Lamictal), levetiracetam (Keppra), methsuximide (Celontin), oxcarbazepine (Trileptal), phenytoin (Dilantin, Phenytek), primidone (Mysoline), rufinamide (Banzel), tiagabine (Gabitril), topiramate (Qudexy, Topamax, Trokendi), valproic acid (Depacon, Depakene, Depakote), vigabatrin (Sabril), and zonisamide (Zonegran)
• Buprenorphine (Buprenex, Butrans)
• Doxepin (Silenor)
• Muscle relaxants such as baclofen (Gablofen, Lioresal), carisoprodol (Soma), cyclobenzaprine (Amrix), dantrolene (Dantrium), methocarbamol (Robaxin), and tizanidine (Zanaflex)
• 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
• Pain medicines such as codeine, fentanyl (Abstral, Actiq, Duragesic, Fentora, Sublimaze), hydrocodone/acetaminophen (Norco, Vicodin), hydromorphone (Dilaudid, Exalgo), meperidine (Demerol), morphine (Kadian, MS Contin), oxycodone (OxyContin, Roxicodone), oxycodone/acetaminophen (Percocet, Roxicet), tapentadol (Nucynta), and tramadol (ConZip, Ultram)
• Parkinson’s disease medicines such as entacapone (Comtan), pramipexole (Mirapex), ropinirole (Requip), and rotigotine (Neupro)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Sleeping pills such as butabarbital (Butisol), eszopiclone (Lunesta), flurazepam, phenobarbital, suvorexant (Belsomra), temazepam (Restoril), triazolam (Halcion), zaleplon (Sonata), and zolpidem (Ambien, Edluar, Intermezzo)
• Thalidomide (Thalomid)

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. Keep the container tightly closed. 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.