GABAPENTIN- gabapentin capsule
Aphena Pharma Solutions - Tennessee, LLC
Gabapentin Capsules, USP
Gabapentin Tablets, USP
(gab'' a pen' tin)
Read the 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.
What is the most important information I should know about gabapentin?
Do not stop taking gabapentin without first talking to your healthcare provider.
Stopping gabapentin suddenly can cause serious problems.
Gabapentin can cause serious side effects including:
1. Suicidal Thoughts. Like other antiepileptic drugs, gabapentin 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 without first talking to a healthcare provider.
2. Changes in behavior and thinking - Using gabapentin 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 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. You may or may not have a rash with an allergic reaction caused by gabapentin. 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.
What is gabapentin?
Gabapentin is a prescription medicine used to treat:
Who should not take gabapentin?
Do not take gabapentin if you are allergic to gabapentin or any of the other ingredients in gabapentin. See the end of this Medication Guide for a complete list of ingredients in gabapentin.
What should I tell my healthcare provider before taking gabapentin?
Before taking gabapentin, tell your healthcare provider if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
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?
If you take too much gabapentin, call your healthcare provider or your local right away at 1-800-222-1222.
What should I avoid while taking gabapentin?
What are the possible side effects of gabapentin?
Gabapentin may cause serious side effects including:
See “What is the most important information I should know about gabapentin?”
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. 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?
Store gabapentin capsules and tablets between 68°F to 77°F (20°C to 25°C).
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 that 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 was written for healthcare professionals.
What are the ingredients in gabapentin capsules, USP and tablets, USP?
Active ingredient: gabapentin, USP
Inactive ingredients in the capsules: Pregelatinized starch (maize) and talc.
The 100-mg capsule shell also contains: gelatin, sodium lauryl sulfate (SLS), titanium dioxide.
The 300-mg capsule shell also contains: gelatin, titanium dioxide, FD&C Red 40, D&C Yellow 10, and sodium lauryl sulfate (SLS).
The 400-mg capsule shell also contains: gelatin, titanium dioxide, sodium lauryl sulfate (SLS), D&C Yellow 10, and FD&C Red 40.
The imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide.
Inactive ingredients in the tablets: poloxamer 407, mannitol, magnesium stearate, hydroxypropyl cellulose, talc, copovidone, crospovidone, colloidal silicon dioxide and opadry white (03F180003).
Opadry white (03F180003) contains hypromellose, titanium dioxide, polyethylene glycol and talc.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
All brands listed are the trademarks of their respective owners.
Manufactured for & Distributed by:
Marlex Pharmaceuticals, Inc.
New Castle, DE 19720 USA