GABAPENTIN- gabapentin tablet, film coated 
Apotex Corp.

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MEDICATION GUIDE

GABAPENTIN TABLETS, USP

Read the Medication Guide before you start taking gabapentin tablets 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.

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

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

Stopping gabapentin tablets suddenly can cause serious problems.

Gabapentin tablets can cause serious side effects including:

1.
Like other antiepileptic drugs, gabapentin tablets 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 tablets without first talking to a healthcare provider.

  • Stopping gabapentin tablets suddenly can cause serious problems. Stopping a seizure medicine suddenly in a patient 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 tablets in children 3 to 12 years of age can cause emotional changes, aggressive behavior, problems with concentration, restlessness, changes in school performance, and hyperactivity.

3.
Gabapentin tablets may cause a serious or life-threatening allergic reaction that may affect your skin or other parts of your body such as your liver or blood cells. You may or may not have rash when you get this type of reaction. It may cause you to be hospitalized or to stop gabapentin tablets. Call a healthcare provider right away if you have any of the following symptoms: 
  • skin rash
  • hives
  • fever
  • swollen glands that do not go away
  • swelling of your lip and 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 tablets.

What are gabapentin tablets?

Gabapentin tablets are a prescription medicine used to treat:

Who should not take gabapentin tablets?

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

What should I tell my healthcare provider before taking gabapentin tablets?

Before taking gabapentin tablets, tell your healthcare provider if you:

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

Taking gabapentin tablets 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 tablets?

What should I avoid while taking gabapentin tablets?

What are the possible side effects of gabapentin tablets?

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 tablets. 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?

Keep gabapentin tablets and all medicines out of the reach of children.

General information about the safe and effective use of gabapentin tablets

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

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

For more information about gabapentin tablets, go to http://www.fda.gov. For medical inquiries or to report side effects regarding gabapentin tablets, please contact Apotex Corp., Drug Safety at 1-800-667-4708 or FDA at 1-800-FDA-1088.

What are the ingredients in gabapentin tablets?

Active ingredient: gabapentin

Inactive ingredients in the tablets: copovidone, magnesium stearate, hypromellose, hydroxypropyl cellulose, polyethylene glycol and titanium dioxide.

This Medication Guide has been approved by the U.S. Food and Drug Administration. This product’s label may have been updated. For current full prescribing information, please visit www.apotex.com

APOTEX INC.

GABAPENTIN TABLETS, USP

Manufactured by:       Manufactured for:

Apotex Inc.                 Apotex Corp.

Toronto, Ontario         Weston, Florida

Canada M9L 1T9       33326 

Revised: June 2013

Revised: 07/2013
 
Apotex Corp.