GABAPENTIN- gabapentin tablet
Cipla USA Inc.
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. Suicidal Thoughts. 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:
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 tablets without first talking to a healthcare provider.
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 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 tablets. You may or may not have a rash with an allergic reaction caused by gabapentin tablets. 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 tablets.
4. Serious breathing problems. Serious breathing problems can occur when Gabapentin Tablets is taken with other medicines that can cause severe sleepiness or decreased awareness, or when it is taken by someone who already has breathing problems. Watch for increased sleepiness or decreased breathing when starting Gabapentin Tablets or when the dose is increased. Get help right away if breathing problems occur.
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:
o Pregnancy Registry: If you become pregnant while taking gabapentin tablets, talk to your healthcare provider about registering with the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The purpose of this registry is to collect information about the safety of antiepileptic drugs during pregnancy. You can enroll in this registry by calling 1-888-233-2334.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Especially tell your healthcare provider if you take any opioid pain medicine (such as oxycodone), any medicines for anxiety (such as lorazepam) or insomnia (such as zolpidem), or any medicines that make you sleepy. You may have a higher chance for dizziness, sleepiness, or breathing problems if these medicines are taken with gabapentin tablets. 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?
o Do not change your dose of gabapentin tablets without talking to your healthcare provider.
o If you take gabapentin tablets and break a tablet in half, the unused half of the tablet should be taken at your next scheduled dose. Half tablets not used within 28 days of breaking should be thrown away
If you take too much gabapentin tablets, call your healthcare provider or your local Poison Control Center right away at 1-800-222-1222.
What should I avoid while taking gabapentin tablets?
What are the possible side effects of gabapentin tablets?
Gabapentin may cause serious side effects including:
See "What is the most important information I should know about 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?
Store gabapentin tablets at 20° to 25°C (68° to 77°F). [see USP controlled room temperature].
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, or to report side effects regarding gabapentin tablets, please call Cipla Ltd. at 1-866-604-3268.
What are the ingredients in gabapentin tablets, USP?
Active ingredient: Gabapentin, USP
Inactive ingredients: Mannitol, Hydroxypropyl Cellulose, Crospovidone, Talc, Magnesium Stearate and Aquarius® BP18114 Cool Vanilla.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
All brand names listed are the registered trademarks of their respective owners and are not trademarks of Cipla Limited.
InvaGen Pharmaceuticals, Inc.
(a subsidiary of Cipla Ltd.)
Hauppauge, NY 11788
Ascent Pharmaceuticals, Inc.
Central Islip, NY 11722
Cipla USA, Inc.
10 Independence Boulevard, Suite 300
Warren, NJ 07059