GABAPENTIN - gabapentin capsule 
REMEDYREPACK INC.

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SPL Medguide Section


Gabapentin Capsules, USP
Rx only
 
Read the Medication Guide before you start taking gabapentin capsules 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 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. 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:  
 


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

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.  

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, restlessness, changes in school performance, and hyperactivity. 

3.  Gabapentin capsules
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 capsules. Call a healthcare provider right away if you have any of the following symptoms:

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.

What are
gabapentin capsules?
 
Gabapentin capsules are a prescription medicine used to treat:

Who should not take gabapentin capsules?

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

What should I tell my healthcare provider before taking
gabapentin capsules?
 
Before taking gabapentin capsules, 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 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.

How should I take gabapentin capsules? 

What should I avoid while taking gabapentin capsules? 

What are the possible side effects of gabapentin capsules? 

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.

How should I store gabapentin capsules? 

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

General information about the safe and effective use of gabapentin capsules

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

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

For more information about gabapentin capsules and for medical inquiries or to report side effects regarding gabapentin capsules, please call 1-866-850-2876.

What are the ingredients in gabapentin capsules?

Active ingredient: gabapentin 

Inactive ingredients: corn starch and talc. The empty hard gelatin capsule shell consists of gelatin, titanium dioxide, and sodium lauryl sulfate. In addition 300 mg also contains yellow iron oxide and 400 mg also contains yellow iron oxide and red iron oxide. The capsules are printed with edible ink containing black iron oxide and shellac.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

* All brands listed are the trademarks of their respective owners and are not trademarks of Aurobindo Pharma Limited.

Manufactured for:
Aurobindo Pharma USA, Inc.
2400 Route 130 North
Dayton, NJ 08810

Manufactured by:
Aurobindo Pharma Limited
Unit-VII (SEZ)
Mahaboob Nagar (Dt)
AP-509302, INDIA

Revised: 05/2013

 

Revised: 03/2014
 
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