PRIMIDONE- primidone tablet 
Amneal Pharmaceuticals of New York LLC

----------

MEDICATION GUIDE

Primidone (prim’ i done) Tablets, USP

Read this Medication Guide before you start taking primidone 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.

What is the most important information I should know about primidone?

Like other antiepileptic drugs, primidone 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:

Do not stop taking primidone 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.

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

What is primidone?

Primidone is a prescription medicine used alone or with other medicines to treat people with:

Who should not take primidone?

Do not take primidone if you:

What should I tell my healthcare provider before taking primidone?

Before you take primidone, 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 primidone 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 each time you get a new medicine.

How should I take primidone tablets?

Take primidone tablets exactly as prescribed. Your healthcare provider will tell you how much primidone tablets to take and when to take it.

What should I avoid while taking primidone?

What are the possible side effects of primidone?

See "What is the most important information I should know about primidone?"

Primidone may cause other serious side effects including:

These are not all the possible side effects of primidone. 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 primidone tablets?

Store primidone tablets at room temperature between 20° to 25°C (68° to 77°F) in a tight, light-resistant container.

Keep primidone tablets and all medicines out of the reach of children.

General Information about primidone

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

For more information, go to www.amneal.com or call 1-877-835-5472.

What are the ingredients in primidone tablets?

Active Ingredient: primidone, USP

Inactive Ingredients: corn starch, lactose monohydrate, magnesium stearate, methyl cellulose, microcrystalline cellulose, sodium lauryl sulfate, and sodium starch glycolate.

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

Manufactured by:
Amneal Pharmaceuticals Pvt. Ltd.
Oral Solid Dosage Unit

Ahmedabad 382213, INDIA

Distributed by:
Amneal Pharmaceuticals LLC
Bridgewater, NJ 08807

Rev. 02-2022-05

Dispense with Medication Guide available at:
documents.amneal.com/mg/primidone-in.pdf

Revised: 10/2021
Amneal Pharmaceuticals of New York LLC