LEVETIRACETAM- levetiracetam solution 
Lupin Pharmaceuticals, Inc.

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                                                                            MEDICATION GUIDE

                                                                     Levetiracetam Oral Solution USP

                                                                                          Rx only

Read this Medication Guide before you start taking levetiracetam oral solution 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 levetiracetam oral solution?

Like other antiepileptic drugs, levetiracetam oral solution may cause suicidal thoughts or actions in a very small number of people, about 1 in 500 people taking it.

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 levetiracetam oral solution without first talking to a healthcare provider.

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

What is levetiracetam oral solution?

Levetiracetam oral solution is a prescription medicine taken by mouth that is used with other medicines to treat:

It is not known if levetiracetam oral solution is safe or effective in children under 1 month of age.

Before taking your medicine, make sure you have received the correct medicine. Compare the name above with the name on your bottle and the appearance of your medicine with the description of levetiracetam oral solution provided below. Tell your pharmacist immediately if you think you have been given the wrong medicine.

Levetiracetam oral solution USP, 100 mg/mL is a clear, colorless, grape-flavored liquid.

What should I tell my healthcare provider before starting levetiracetam oral solution?

Before taking levetiracetam oral solution, 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 nonprescription medicines, vitamins, and herbal supplements. Do not start a new medicine without first talking with your healthcare provider.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist each time you get a new medicine.

How should I take levetiracetam oral solution?

Take levetiracetam oral solution exactly as prescribed.

What should I avoid while taking levetiracetam oral solution?

Do not drive, operate machinery or do other dangerous activities until you know how levetiracetam oral solution affect you. Levetiracetam oral solution may make you dizzy or sleepy.

What are the possible side effects of levetiracetam oral solution?

Levetiracetam oral solution can cause serious side effects.

Call your healthcare provider right away if you have any of these symptoms:

The most common side effects seen in people who take levetiracetam oral solution include:

The most common side effects seen in children who take levetiracetam oral solution include, in addition to those listed above:

These side effects can happen at any time but happen more often within the first 4 weeks of treatment except for infection.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of levetiracetam oral solution. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Lupin Pharmaceuticals, Inc. at 1-800-399-2561.

How should I store levetiracetam oral solution?

General information about levetiracetam oral solution.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use levetiracetam oral solution for a condition for which it was not prescribed. Do not give levetiracetam oral solution 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 levetiracetam oral solution. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about levetiracetam oral solution that is written for health professionals. You can also get information about levetiracetam oral solution at www.lupinpharmaceuticals.com or call 1-800-399-2561.

What are the ingredients of levetiracetam oral solution USP?

Levetiracetam Oral Solution USP

Active Ingredient: Levetiracetam USP

Inactive Ingredients: ammonium glycyrrhizinate, acesulfame potassium, citric acid monohydrate, glycerin, maltitol solution, methyl paraben, propyl paraben, purified water, sodium citrate dihydrate and artificial flavor.

Levetiracetam oral solution does not contain lactose or gluten. It does contain carbohydrates. The liquid is dye-free.

Information on the use of levetiracetam in pediatric patients less than 4 years of age as adjunctive therapy in the treatment of partial onset seizures is approved for UCB, Inc.'s levetiracetam oral solution. However, due to UCB, Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

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

Manufactured for:

Lupin Pharmaceuticals, Inc.

Baltimore, Maryland 21202

United States.

Manufactured by:

Lupin Limited

Aurangabad 431 210

INDIA.

Revised: May 2014                                                                              ID# 237570

Revised: 05/2014
 
Lupin Pharmaceuticals, Inc.