SPL MEDGUIDE SECTION

What is the most important information I should know about gabapentin capsules?
Do not stop taking gabapentin capsules without first talking to your healthcare provider.
Stopping gabapentin capsules suddenly can cause serious problems.
Gabapentin capsules can cause serious side effects including:
1. Suicidal Thoughts. Like other antiepileptic drugs, gabapentin capsules may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.
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
• 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.

Do not stop taking gabapentin capsules without first talking to a healthcare provider.
• Stopping gabapentin capsules suddenly can cause serious problems. Stopping a seizure medicine suddenly in a person who has epilepsy can cause seizures that will not stop (status epilepticus).
• Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.

2. Changes in behavior and thinking. Using gabapentin capsules in children 3 to 12 years of age can cause emotional changes, aggressive behavior, problems with concentration, changes in school performance, restlessness, and hyperactivity.

3. Gabapentin capsules may cause serious or life-threatening allergic reactions that may affect your skin or other parts of your body such as your liver or blood cells. This may cause you to be hospitalized or to stop gabapentin capsules. You may or may not have a rash with an allergic reaction caused by gabapentin capsules. Call a healthcare provider right away if you have any of the following symptoms:
• skin rash
• hives
• difficulty breathing
• fever
• swollen glands that do not go away
• swelling of your face, lips, throat, or tongue
• yellowing of your skin or of the whites of the eyes
• unusual bruising or bleeding
• severe fatigue or weakness
• unexpected muscle pain
• frequent infections
These symptoms may be the first signs of a serious reaction. A healthcare provider should examine you to decide if you should continue taking gabapentin capsules.

4. Serious breathing problems. Serious breathing problems can happen when gabapentin capsules are taken with other medicines (such as opioid pain medicines) that can cause severe sleepiness or decreased awareness, or when it is taken by someone who already has breathing problems. Call your healthcare provider or get medical help right away if you have any of the following symptoms:
• feel short of breath • feel very tired • dizziness
• breathing slower than normal • confusion • headache
Be sure that your caregiver or family members know which symptoms may be serious so they can call your healthcare provider or get medical help if you are unable to seek treatment on your own.
Your healthcare provider may lower your dose or stop your treatment with gabapentin capsules if you have serious breathing problems.

Before taking gabapentin capsules, tell your healthcare provider about all of your medical conditions including if you:
• have or have had kidney problems or are on hemodialysis.
• have or have had depression, mood problems, or suicidal thoughts or behavior.
• have a history of drug abuse.
• have diabetes.
• have breathing problems.
• are pregnant or plan to become pregnant. It is not known if gabapentin capsules can harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking gabapentin capsules. You and your healthcare provider will decide if you should take gabapentin capsules while you are pregnant.
o Pregnancy Registry: If you become pregnant while taking gabapentin capsules, 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 during pregnancy. You can enroll in this registry by calling 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/.
• are breastfeeding or plan to breastfeed. Gabapentin can pass into breast milk. You and your healthcare provider should decide how you will feed your baby while you take gabapentin capsules.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Especially tell your healthcare provider if you take:
• any opioid pain medicine such as morphine, hydrocodone, oxycodone, or buprenorphine.
• any medicines for anxiety (such as lorazepam) or insomnia (such as zolpidem), or any medicines that make you sleepy. You may have a higher chance for dizziness, sleepiness, or breathing problems if these medicines are taken with gabapentin capsules.

Taking gabapentin capsules 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.

What are the possible side effects of gabapentin capsules?
Gabapentin capsules may cause serious side effects, including:
• See “What is the most important information I should know about gabapentin capsules?”
• problems driving while using gabapentin capsules. See “What should I avoid while taking gabapentin capsules?”
• sleepiness and dizziness, which could increase your chance of having an accidental injury, including falls.

The most common side effects of gabapentin capsules include:
• lack of coordination
• viral infection
• difficulty with speaking
• tremor
• swelling, usually of legs and feet
• feeling tired
• fever

• feeling drowsy
• nausea and vomiting
• jerky movements
• difficulty with coordination
• double vision
• unusual eye movement
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of gabapentin capsules. 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.