GABAPENTIN- gabapentin capsule
Department of State Health Services, Pharmacy Branch
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MEDICATION GUIDE
Gabapentin Capsules USP
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. 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.
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 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 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. 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 non-prescription 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?
Take gabapentin exactly as prescribed. Your healthcare provider will tell you how much gabapentin to take.
Do not change your dose of gabapentin without talking to your healthcare provider. If taking capsules, always swallow them whole with plenty of water.
Gabapentin can be taken with or without food. If you take an antacid containing aluminum and magnesium, such as Maalox ®, Mylanta ®, Gelusil ®, Gaviscon ®, or Di-Gel ®, you should wait at least 2 hours before taking your next dose of gabapentin.
If you take too much gabapentin, call your healthcare provider or your local Poison Control Center right away.
What should I avoid while taking gabapentin?
Do not drink alcohol or take other medicines that make you sleepy or dizzy while taking gabapentin without first talking with your healthcare provider. Taking gabapentin with alcohol or drugs that cause sleepiness or dizziness may make your sleepiness or dizziness worse.
Do not drive, operate heavy machinery, or do other dangerous activities until you know how gabapentin affects you. gabapentin can slow your thinking and motor skills.
What are the possible side effects of gabapentin?
See “What is the most important information I should know about gabapentin?”
The most common side effects of gabapentin include:
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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 between 20° to 25°C (68° to 77°F); [see USP Controlled Room Temperature].
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?
Active ingredient: gabapentin
Inactive ingredients in the capsules:anhydrous lactose, cornstarch, and talc. The 100-mg capsule shell also contains: gelatin, sodium lauryl sulfate, and titanium dioxide. The 300-mg capsule shell also contains: gelatin, sodium lauryl sulfate, titanium dioxide, and yellow iron oxide. The 400-mg capsule shell also contains: gelatin, sodium lauryl sulfate, red iron oxide, titanium dioxide, and yellow iron oxide. The imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propyl glycol, strong ammonia solution, and titanium dioxide.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Manufactured by:
Alkem Laboratories Limited
ALKEM HOUSE, Lower Parel,
Mumbai – 400 013, INDIA
Distributed by:
Ascend Laboratories, LCC
Montvale, NJ 07645
Revised June 2013