MEDICATION GUIDE

Gabapentin (gab" a pen' tin) Tablets

Read this Medication Guide before you start taking gabapentin and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. If you have any questions about gabapentin, ask your healthcare provider or pharmacist.

What is the most important information I should know about gabapentin?

Do not stop taking gabapentin without first talking with your healthcare provider. Stopping gabapentin suddenly can cause serious problems.

Like other antiepileptic drugs, gabapentin, the active ingredient in gabapentin tablet, may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. However, it is not known if gabapentin is safe and effective in people with seizure problems (epilepsy). Therefore, gabapentin tablet should not be used in place of other gabapentin products.

Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:

• thoughts about suicide or dying
• attempts to commit suicide
• serious breathing problems
• new or worse depression
• new or worse anxiety
• feeling agitated or restless
• panic attacks
• trouble sleeping (insomnia)
• new or worse irritability
• acting aggressive, being angry, or violent
• acting on dangerous impulses
• an extreme increase in activity and talking (mania)
• other unusual changes in behavior or mood

How can I watch for early symptoms of suicidal thoughts and actions?

• Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.
• Keep all follow-up visits with your healthcare provider as scheduled.
• Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

Serious breathing problems

• Serious breathing problems can occur when gabapentin is taken with other medicines that can cause severe sleepiness or decreased awareness, or when it is taken by someone who already has breathing problems. Watch for increased sleepiness or decreased breathing when starting gabapentin or when the dose is increased. Get help right away if breathing problems occur.

Do not stop taking gabapentin without first talking with your healthcare provider.

• Stopping gabapentin suddenly can cause serious problems.

What is gabapentin?

Gabapentin is a prescription medicine used in adults, 18 years and older, to treat:

• pain from damaged nerves (neuropathic pain) that follows healing of shingles (a painful rash that comes after a herpes zoster infection).

It is not known if gabapentin is safe and effective in people with seizure problems (epilepsy).

It is not known if gabapentin is safe and effective in children under 18 years of age with postherpetic pain.

Gabapentin tablet is not interchangeable with other gabapentin products.

Who should not take gabapentin?

Do not take gabapentin tablet if you are allergic to gabapentin or any of the ingredients in gabapentin tablet. See the end of this Medication Guide for a complete list of ingredients in gabapentin tablet.

What should I tell my healthcare provider before taking gabapentin?

Before taking gabapentin, tell your healthcare provider if you:

• have or have had depression, mood problems or suicidal thoughts or behavior
• have breathing problems
• have seizures
• have kidney problems or get kidney dialysis
• are pregnant or plan to become pregnant. It is not known if gabapentin can harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking gabapentin. You and your healthcare provider will decide if you should take gabapentin while you are pregnant.

If you become pregnant while taking gabapentin, talk to your healthcare provider about registering with the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The purpose of this registry is to collect information about the safety of antiepileptic drugs, including gabapentin, the active ingredient in gabapentin tablet, during pregnancy. You can enroll in this registry by calling 1-888-233-2334.

• are breastfeeding or plan to breastfeed. Gabapentin passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with gabapentin.

Tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins or herbal supplements. Especially tell your healthcare provider if you take any opioid pain medicine (such as oxycodone), or medicines for anxiety (such as lorazepam) or insomnia (such as zolpidem). You may have a higher chance for dizziness, sleepiness or serious breathing problems if these medicines are taken with gabapentin.

Taking gabapentin with certain other medicines can cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider.

Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.

How should I take gabapentin?

•   Take gabapentin exactly as prescribed. Your healthcare provider will tell you how much gabapentin to take and when to take it. Take gabapentin at the same time each day.
•   Do not change your dose or stop taking gabapentin without talking with your healthcare provider. If you stop taking gabapentin suddenly, you may experience side effects. Talk with your healthcare provider about how to stop gabapentin slowly.
•   Take gabapentin with food one time each day with your evening meal.
•   Take gabapentin tablets whole. Do not split, crush, or chew gabapentin tablets before swallowing.
•   Your healthcare provider may change your dose of gabapentin. Do not change your dose of gabapentin without talking to your healthcare provider.
•   If you miss a dose, take it as soon as you remember with food. If it is almost time for your next dose, just skip the missed dose. Take the next dose at your regular time. Do not take two doses at the same time.
•   If you take too much gabapentin, call your healthcare provider or poison control center, or go to the nearest emergency room right away.
•   If you are taking an antacid containing aluminum hydroxide and magnesium hydroxide, it is recommended that gabapentin be taken at least 2 hours following administration of the antacid.

What should I avoid while taking gabapentin?

• Do not drink alcohol or take other medicines that make you sleepy or dizzy while taking gabapentin without first talking to your healthcare provider. Taking gabapentin with alcohol or medicines that cause sleepiness or dizziness may make your sleepiness or dizziness worse.
• Do not operate heavy machines or do other dangerous activities until you know how gabapentin affects you. Gabapentin can slow your thinking and motor skills.

What are the possible side effects of gabapentin?

The most common side effect of gabapentin is:

• dizziness

Tell your healthcare provider about any side effect that bothers you or that does not go away.

These are not all the possible side effects of gabapentin. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store gabapentin tablets?

• Store gabapentin tablets at 20°C to 25°C (68°F to 77°F).
• Gabapentin tablets come in child-resistant bottles of 90's.
• Keep gabapentin and all medicines out of the reach of children.

General information about the safe and effective use of gabapentin

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use gabapentin for a condition for which it was not prescribed. Do not give gabapentin to other people, even if they have the same symptoms you have. It may harm them.

This Medication Guide summarizes the most important information about gabapentin. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about gabapentin that is written for health professionals.

Please address all medical inquiries to, MedicalAffairs@zydususa.com or Tel.: 1-877-993-8779.

What are the ingredients in gabapentin tablet?

Active ingredient: gabapentin, USP

Inactive ingredients: copovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyethylene oxide, povidone, talc and titanium dioxide.

Medication Guide available at www.zydususa.com/medguides or call 1-877-993-8779.