EXTENDED PHENYTOIN SODIUM - phenytoin sodium capsule 
Aurobindo Pharma Limited

----------

MEDICATION GUIDE

Extended Phenytoin Sodium Capsules USP

(fen' i toin soe' dee um)

 

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

1. Do not stop taking extended phenytoin sodium capsules without first talking to your healthcare provider.


2. 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:


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.

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.


3. Extended phenytoin sodium capsules can cause a type of serious allergic reaction that may affect different parts of the body such as your liver, kidneys, blood, heart, skin or other parts of your body. These can be very serious and cause death. Call your healthcare provider right away if you have any or all of these symptoms:



Call your healthcare provider even if the symptoms are mild or if you have been taking extended phenytoin sodium capsules for an extended period of time. These symptoms can be a sign of a serious allergic reaction.

4. Extended phenytoin sodium capsules can cause problems with your heart, including a slow heartbeat. Let your healthcare provider know right away if you have any of these symptoms:




What are extended phenytoin sodium capsules?

Extended phenytoin sodium capsules are a prescription medicine used to treat certain types of seizures called tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures.

Do not take extended phenytoin sodium capsules if you:


Before taking extended phenytoin sodium capsules, tell your healthcare provider about all of your medical conditions, including if you:


Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. These medicines can change the levels of extended phenytoin sodium capsules in your blood.


Taking extended phenytoin sodium capsules 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 extended phenytoin sodium capsules?


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:



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

The most common side effects of extended phenytoin sodium capsules include:


Extended phenytoin sodium capsules can cause overgrowth of your gums. Brushing and flossing your teeth and seeing a dentist regularly while taking extended phenytoin sodium capsules can help prevent this from happening.


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


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 sodium capsules and all medicines out of the reach of children.

General information about the safe and effective use of 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. You can ask your pharmacist or healthcare provider for information about extended phenytoin sodium capsules that is written for health professionals.

What are the ingredients in extended phenytoin sodium capsules?

Active ingredient: phenytoin sodium


Inactive ingredients: confectioner’s sugar, hypromellose, magnesium oxide, magnesium stearate, microcrystalline cellulose, and talc. In addition, the empty hard gelatin capsule shells also contain gelatin, sodium lauryl sulphate, and titanium dioxide. The capsules are imprinted with edible ink containing black iron oxide, potassium hydroxide, propylene glycol and shellac.


For more information, call Aurobindo Pharma USA, Inc. at 1-866-850-2876.


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


The brands listed are trademarks of their respective owners and are not trademarks of Aurobindo Pharma Limited.
Dispense with Medication Guide available at: www.aurobindousa.com/medication-guides


Distributed by:
Aurobindo Pharma USA, Inc.
279 Princeton-Hightstown Road
East Windsor, NJ 08520

Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 038, India

Revised: 10/2020

Revised: 10/2020
Aurobindo Pharma Limited