EXTENDED PHENYTOIN SODIUM- phenytoin sodium capsule 
American Health Packaging

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MEDICATION GUIDE

8237601/0718
MEDICATION GUIDE
Extended Phenytoin (FEN-i-toyn) Sodium Oral Capsules

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. Stopping extended phenytoin sodium capsules suddenly can cause serious problems.
  3. Stopping a seizure medicine suddenly can cause you to have seizures more often or seizures that will not stop (status epilepticus).
  4. 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:
  5. Thoughts about suicide or dying
  6. New or worse anxiety
  7. Trouble sleeping (insomnia)
  8. Acting on dangerous impulses
  9. Attempts to commit suicide
  10. Feeling agitated or restless
  11. New or worse irritability
  12. An extreme increase in activity and talking (mania)
  13. New or worse depression
  14. Panic attacks
  15. Acting aggressive, being angry, or violent
  16. Other unusual changes in behavior or mood

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.

  1. 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:
  2. Fever
  3. Sore throat
  4. Not wanting to eat (anorexia)
  5. Rash
  6. Sores in your mouth
  7. Nausea
  8. Swollen lymph glands
  9. Bruise easily
  10. Vomiting
  11. Swelling of your face, eye, lips, or tongue
  12. Trouble swallowing or breathing
  13. Purple or red spots on your skin
  14. Increase infections
  15. Yellowing of the skin and the white part of your eyes (jaundice)

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.

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 phenytoin 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?
Extended phenytoin sodium capsules 100 mg:
white opaque / light lavender opaque, hard gelatin capsules imprinted with "IP 212" on both cap and body.
Active ingredient: 100 mg phenytoin sodium, USP
Inactive ingredients:
D&C Red #28, D&C Red #33, FD&C Blue #1, gelatin, hydroxypropyl cellulose, mannitol, magnesium stearate, talc and titanium dioxide.

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

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

Distributed by:
American Health Packaging
Columbus, OH 43217

8237601/0718

Revised: 7/2019
American Health Packaging