SPL MEDGUIDE

MEDICATION GUIDE

Extended Phenytoin Sodium Capsules, USP 100 mg

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 extended phenytoin sodium capsules, USP?

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:

• thoughts about suicide or dying
• attempts to commit suicide
• new or worse depression
• new or worse anxiety
• feeling agitated or restless
• panic attacks
• trouble sleeping (insomnia)
• new or worse irritability
• acting aggressive, being angry, or violent
• acting on dangerous impulses
• an extreme increase activity and talking (mania)
• other unusual changes in behavior or mood

How can I watch for early symptoms of suicidal thoughts and actions?

• Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.
• Keep all follow-up visits with your health-care provider as scheduled.

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.

• If you take extended phenytoin sodium capsules during pregnancy, your baby is at risk for serious birth defects.
• Birth defects may occur even in children born to women who are not taking any medicines and do not have other risk factors
• If you take extended phenytoin sodium capsules during pregnancy, your baby is also at risk for bleeding problems right after birth. Your healthcare provider may give you and your baby medicine to prevent this.
• All women of child-bearing age should talk to their healthcare provider about using other possible treatments instead of extended phenytoin sodium capsules. If the decision is made to use extended phenytoin sodium capsules, you should use effective birth control (contraception) unless you are planning to become p regnant.
• Tell your healthcare provider right away if you become pregnant while taking extended phenytoin sodium capsules. You and your healthcare provider should decide if you will take extended phenytoin sodium capsules while you are pregnant.
• Pregnancy Registry: If you become pregnant while taking extended phenytoin sodium capsules, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334. The purpose of this registry is to collect information about the safety of antiepileptic drugs during pregnancy.

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 include:

• swelling of your face, eyes, lips, or tongue
• trouble swallowing or breathing
• a skin rash
• hives
• fever, swollen glands, or sore throat that do not go away or come and go
• painful sores in the mouth or around your eyes
• yellowing of your skin or eyes
• unusual bruising or bleeding
• severe fatigue or weakness
• severe muscle pain
• frequent infections or an infection that does not go away

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

What is extended phenytoin sodium capsules, USP?

Extended phenytoin sodium capsule is 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, USP?

Do not take extended phenytoin sodium capsules if you:

• are allergic to phenytoin or any of the ingredients in extended phenytoin sodium capsules. See the end of this leaflet for a complete list of ingredients in extended phenytoin sodium capsules.
• have had an allergic reaction to CEREBYX* (fosphenytoin), PEGANONE* (ethotoin), or MESANTOIN* (mephenytoin).

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

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

• Have or had liver disease
• Have or had porphyria
• Have or had diabetes
• Have or have had depression, mood problems, or suicidal thoughts or behavior
• Are pregnant or plan to become pregnant.

o     If you become pregnant while taking extended phenytoin sodium capsules, the level of extended phenytoin sodium capsules in your blood may decrease, causing your seizures to become worse. Your healthcare provider may change your dose of extended phenytoin sodium capsules.

• Are breast feeding or plan to breastfeed. Extended phenytoin sodium capsules can pass into breast milk. You and your healthcare provider should decide if you will take extended phenytoin sodium capsules or breastfeed. You should not do both.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

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, USP?

• Take extended phenytoin sodium capsules exactly as prescribed. Your healthcare provider will tell you how much extended phenytoin sodium capsules to take.
• Your healthcare provider may change your dose. Do not change your dose of extended phenytoin sodium capsules without talking to your healthcare provider.
• 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.
• If you take too much extended phenytoin sodium capsules, call your healthcare provider or local Poison Control Center right away.
• 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.

What should I avoid while taking extended phenytoin sodium capsules, USP?

Do not drink alcohol while you take extended phenytoin sodium capsules without first talking to your healthcare provider. Drinking alcohol while taking extended phenytoin sodium capsules may change your blood levels of extended phenytoin sodium capsules which can cause serious problems.

Do not drive, operate heavy machinery, or do other dangerous activities until you know how an extended phenytoin sodium capsule affects you. Extended phenytoin sodium capsules can slow your thinking and motor skills.

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

See "What is the most important information I should know about extended phenytoin sodium capsules, USP?"

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

●    Softening of your bones (osteomalacia). This can cause broken bones.

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:

●    problems with walking and coordination	●    tremor
●    slurred speech	●    headache
●    confusion	●    nausea
●    dizziness	●    vomiting
●    trouble sleeping	●    constipation
●    nervousness	●    rash

These are not all the possible side effects of extended phenytoin sodium capsules. For more information, ask your health-care 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, USP?

●    Store extended phenytoin sodium capsules at 20°-25°C (68°-77°F) (See USP controlled room temperature). Preserve in tight, light-resistant containers. Protect from moisture.

Keep extended phenytoin sodium capsules 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, call 1-800-346-6854.

What are the ingredients in extended phenytoin sodium capsules, USP?

Extended phenytoin sodium capsules, USP 100 mg: Each capsule contains a white to off white granular powder. The orange/orange size ‘3’ hard gelatin capsules, imprinted on body ‘W720’ in black ink.

Active ingredient: phenytoin sodium USP

Inactive ingredients: Colloidal silicon dioxide NF, Hypromellose USP, Magnesium oxide light USP, Magnesium stearate NF, Talc USP.

The capsule shell contains D&C yellow # 10, FD&C blue # 1, FD&C red  # 40, gelatin, titanium dioxide and black edible ink.

*The brand names mentioned in this Medication Guide are registered trademarks of their respective manufactures.

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

Manufactured by:

Wockhardt Limited,

Mumbai, India.

Distributed by:

Wockhardt USA LLC.

20 Waterview Blvd.

Parsippany, NJ 07054

USA.

Rev.030412