FELBAMATE- felbamate suspension
Amneal Pharmaceuticals LLC
Felbamate (fel-BAM-ate) Oral Suspension, USP
Read this Medication Guide before you start taking felbamate oral suspension 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 felbamate oral suspension?
Do not stop taking felbamate oral suspension without first talking to your healthcare provider.
Stopping felbamate oral suspension suddenly can cause serious problems.
Felbamate oral suspension can cause serious side effects, including:
1. Felbamate oral suspension may cause serious blood problems that may be life-threatening.
Call your healthcare provider right away if you have any of the following symptoms:
2. Liver problems that may be life-threatening. Call your healthcare provider right away if you have any of these symptoms:
3. Like other antiepileptic drugs, felbamate oral suspension may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.
Call your 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 felbamate oral suspension without first talking to a healthcare provider.
Stopping felbamate oral suspension suddenly can cause serious problems. You should talk to your health care provider before stopping. Stopping a seizure medicine suddenly in a patient who has epilepsy can cause seizures.
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.
What is felbamate oral suspension?
Felbamate oral suspension is a prescription medicine used when other treatments have failed in:
Who should not take felbamate oral suspension?
Do not take felbamate oral suspension if you:
What should I tell my healthcare provider before taking felbamate oral suspension?
Before you take felbamate oral suspension, 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 felbamate oral suspension 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 felbamate oral suspension?
What should I avoid while taking felbamate oral suspension?
What are the possible side effects of felbamate oral suspension?
See “What is the most important information I should know about felbamate oral suspension?”
Felbamate oral suspension may cause serious side effects including:
The most common side effects of felbamate oral suspension include:
These are not all the possible side effects of felbamate oral suspension. For more information, ask your healthcare provider or pharmacist.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
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 felbamate oral suspension?
Keep felbamate oral suspension and all medicines out of the reach of children.
General information about felbamate oral suspension.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use felbamate oral suspension for a condition for which it was not prescribed. Do not give felbamate oral suspension to other people, even if they have the same symptoms that you have. It may harm them.
What are the ingredients of felbamate oral suspension?
Active Ingredient: felbamate, USP
Inactive ingredients: bubble gum flavor, carboxymethyl cellulose sodium, FD&C Yellow No. 6, FD&C Red No. 40, glycerin, methylparaben, microcrystalline cellulose, polysorbate 80, propylparaben, purified water, saccharin sodium, simethicone, and sorbitol.
This Medication Guide summarizes the most important information about felbamate. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about felbamate that is written for health professionals.
For more information, go to www.amneal.com or call 1-877-835-5472.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Amneal Pharmaceuticals LLC
Bridgewater, NJ 08807