EXTENDED PHENYTOIN SODIUM- phenytoin sodium capsule 
Amneal Pharmaceuticals of New York, LLC

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MEDICATION GUIDE

Extended Phenytoin (FEN-i-toyn) Sodium Capsules

Read this Medication Guide before you start taking extended phenytoin sodium capsules 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. If you have any questions about extended phenytoin sodium capsules, ask your healthcare provider or pharmacist.

What is the most important information I should know about extendedphenytoin sodium capsules?

Do not stop taking extended phenytoin sodium capsules without first talking to your healthcare provider. Stopping extended phenytoin sodium capsules suddenly can cause serious problems.

Extended phenytoin sodium capsules can cause serious side effects including:

1.   Like other antiepileptic drugs, extended phenytoin sodium capsules 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 extended phenytoin sodium capsules without first talking to a healthcare provider.

Stopping extended phenytoin sodium capsules suddenly can cause serious problems. Stopping a seizure medicine suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus).

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. Extended phenytoin sodium capsules may harm your unborn baby.

3. Swollen glands (lymph nodes)

4. Allergic reactions or serious problems which may affect organs and other parts of your body like the liver or blood cells. You may or may not have a rash with these types of reactions. Symptoms can include any of the following:

Call your healthcare provider right away if you have any of the symptoms listed above.

What are extended phenytoin sodium capsules?

Extended phenytoin sodium capsules are a prescription medicine used to treat tonic-clonic (grand mal), complex partial (psychomotor or temporal lobe) seizures, and to prevent and treat seizures that happen during or after brain surgery.

Who should not take extended phenytoin sodium capsules?

Do not take extended phenytoin sodium capsules if you:

What should I tell my healthcare provider before taking extended phenytoin sodium capsules?

Before you take extended phenytoin sodium capsules, tell your healthcare provider if you:

Tell your healthcare provider about all the medicines you take, including prescription and

What should I avoid while taking extended phenytoin sodium capsules?

What are the possible side effects of extended phenytoin sodium capsules?

See “What is the most important information I should know about extended phenytoin sodium capsules?”

Extended phenytoin sodium capsules may cause other serious side effects including:

These are not all the possible side effects of extended phenytoin sodium capsules. 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 extended phenytoin sodium capsules?

Keep extended phenytoin sodiumcapsules and all medicines out of the reach of children.

General information about extended phenytoin sodium capsules

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use extended phenytoin sodium capsules for a condition for which it was not prescribed. Do not give extended phenytoin sodium capsules 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 extended phenytoin sodium capsules. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about extended phenytoin sodium capsules that was written for healthcare professionals.

For more information about extended phenytoin sodium capsules, visit www.amneal.com or call 1-877-835-5472.

What are the ingredients in extended phenytoin sodium capsules?

Extended Oral Capsule

Extended phenytoin sodium capsule 100mg:  White opaque/lavender opaque, hard gelatin capsules imprinted “IP 212” on both cap and body.

Active ingredient: 100 mg phenytoin sodium

Inactive ingredients: D&C Red #28, D&C Red #33, FD&C Blue #1, gelatin, hydroxypropyl cellulose, mannitol, magnesium stearate, talc and titanium dioxide.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Revised: 04/2014
 
Amneal Pharmaceuticals of New York, LLC