PHENYTOIN- phenytoin tablet, chewable 
Mylan Institutional Inc.

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MEDICATION GUIDE

PHENYTOIN CHEWABLE TABLETS, USP 

(fen′ i toin)

50 mg

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

What is the most important information I should know about phenytoin chewable tablets?

Do not stop taking phenytoin chewable tablets without first talking to your healthcare provider.

Stopping phenytoin chewable tablets suddenly can cause serious problems.

Phenytoin chewable tablets can cause serious side effects including:

1. Like other antiepileptic drugs, phenytoin chewable tablets 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 phenytoin chewable tablets without first talking to a healthcare provider.

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. Phenytoin chewable tablets 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 phenytoin chewable tablets?

Phenytoin chewable tablets 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 phenytoin chewable tablets?

Do not take phenytoin chewable tablets if you:

What should I tell my healthcare provider before taking phenytoin chewable tablets?

Before you take phenytoin chewable 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 phenytoin chewable 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 phenytoin chewable tablets?

What should I avoid while taking phenytoin chewable tablets?

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

Do not drive, operate heavy machinery, or do other dangerous activities until you know how phenytoin affects you. Phenytoin can slow your thinking and motor skills.

What are the possible side effects of phenytoin chewable tablets?

See "What is the most important information I should know about phenytoin chewable tablets?".

Phenytoin chewable tablets 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 phenytoin chewable tablets include:

These are not all the possible side effects of phenytoin chewable 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 phenytoin chewable tablets?

Keep phenytoin chewable tablets and all medicines out of the reach of children.

General information about phenytoin chewable tablets

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

For more information about phenytoin chewable tablets, call Mylan Pharmaceuticals Inc. at 1-877-446-3679 (1-877-4-INFO-RX).

What are the ingredients in phenytoin chewable tablets?

The 50 mg tablets are pink, round tablets debossed with M above the score and P50 below the score on one side of the tablet and blank on the other side.

Active ingredient: 50 mg phenytoin

Inactive ingredients: colloidal silicon dioxide, compressible sugar, corn starch, D&C Red No. 30 Aluminum Lake, magnesium stearate, peppermint flavor and talc.

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

*These are registered trademarks of their respective manufacturers.

Manufactured by:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Distributed by:
Mylan Institutional Inc.
Rockford, IL 61103 U.S.A.

S-11355
12/12

Revised: 12/2012
 
Mylan Institutional Inc.