GABAPENTIN- gabapentin solution 
Amneal Pharmaceuticals of New York, LLC

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MEDICATION GUIDE

Gabapentin (GA-be-PEN-tin) Oral Solution

Read the Medication Guide before you start taking gabapentin oral solution 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 oral solution? Do not stop taking gabapentin oral solution without first talking to your healthcare provider.

Stopping gabapentin oral solution suddenly can cause serious problems.

Gabapentin oral solution can cause serious side effects including:

1. Suicidal Thoughts. Like other antiepileptic drugs, gabapentin oral solution 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 oral solution without first talking to a healthcare provider.

2. Changes in behavior and thinking - Using gabapentin oral solution 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 oral solution 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 oral solution. 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 oral solution.

What is gabapentin oral solution?

Gabapentin oral solution is a prescription medicine used to treat:

Who should not take gabapentin oral solution?

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

What should I tell my healthcare provider before taking gabapentin oral solution?

Before taking gabapentin oral solution, tell your healthcare provider if you:

What are the possible side effects of gabapentin oral solution?

Gabapentin oral solutionmay cause serious side effects including:

See “What is the most important information I should know about gabapentin oral solution?”

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 oral solution. 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 oral solution?

Keep gabapentin oral solution and all medicines out of the reach of children.

General information about the safe and effective use of gabapentin oral solution

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use gabapentin oral solution for a condition for which it was not prescribed. Do not give gabapentin oral solution 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 oral solution. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about gabapentin oral solution that was written for healthcare professionals.

For more information go to http://www.amneal.com. or call 1-877-835-5472.

What are the ingredients in gabapentin oral solution?

Active ingredient: gabapentin, USP

Inactive ingredients in the oral solution: acesulfame potassium, carboxymethylcellulose sodium, magnasweet, peppermint flavor, potassium sorbate and strawberry anise artificial flavor. Sodium hydroxide or hydrochloric acid may be added for adjustment of pH.

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.amneal.com

*Trademarks are the property of their respective owners.

Manufactured by:
Amneal Pharmaceuticals of NY
Hauppauge, NY 11788

Distributed by:
Amneal Pharmaceuticals
Glasgow, KY 42141

Rev. 09-2014-00

Revised: 08/2014
 
Amneal Pharmaceuticals of New York, LLC