FELBAMATE- felbamate tablet
Amneal Pharmaceuticals of New York LLC
Felbamate (fel bam’ ate) Tablets, USP
Read this Medication Guide before you start taking felbamate 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 felbamate tablets?
Do not stop taking felbamate tablets without first talking to your healthcare provider.
Stopping felbamate tablets suddenly can cause serious problems.
Felbamate tablets can cause serious side effects, including:
1. Felbamate tablets 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 tablets 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 tablets without first talking to a healthcare provider.
Stopping felbamate tablets 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 tablets?
Felbamate tablets is a prescription medicine used when other treatments have failed in:
Who should not take felbamate tablets?
Do not take felbamate tablets if you:
What should I tell my healthcare provider before taking felbamate tablets?
Before you take felbamate tablets, 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 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 felbamate tablets?
What should I avoid while taking felbamate tablets?
What are the possible side effects of felbamate tablets?
See “What is the most important information I should know about felbamate tablets?”
Felbamate tablets may cause serious side effects including:
The most common side effects of felbamate tablets include:
These are not all the possible side effects of felbamate tablets. 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 tablets?
Store felbamate tablets at room temperature between 68° to 77°F (20° to 25°C).
Keep felbamate tablets and all medicines out of the reach of children.
General information about felbamate tablets.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use felbamate for a condition for which it was not prescribed. Do not give felbamate to other people, even if they have the same symptoms that you have. It may harm them.
What are the ingredients in felbamate tablets?
Active Ingredient: felbamate, USP
The inactive ingredients for felbamate tablets 400 mg and 600 mg are croscarmellose sodium, FD&C Yellow No. 6, D&C Yellow No. 10 and FD&C Red No. 40 (600 mg tablets only), lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized starch.
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 Pvt. Ltd.
Oral Solid Dosage Unit
Ahmedabad 382213, INDIA
Amneal Pharmaceuticals LLC
Bridgewater, NJ 08807