LEVETIRACETAM - levetiracetam solution 
Silarx Pharmaceuticals, Inc

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MEDICATION GUIDE

Levetiracetam 100 mg/mL Oral Solution

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?

Like other antiepileptic drugs, Levetiracetam 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 without first talking to a healthcare provider.

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

What is Levetiracetam?
Levetiracetam is a medicine taken by mouth that is used with other medicines to treat:

It is not known if Levetiracetam is safe or effective in children under 4 years 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 provided below. Contact your pharmacist immediately if you believe a dispensing error may have occurred.

Levetiracetam oral solution is a clear, colorless, grape-flavored liquid.

What should I tell my healthcare provider before starting Levetiracetam?

Before taking Levetiracetam, 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, 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?

Take Levetiracetam exactly as prescribed.

What should I avoid while taking Levetiracetam?
Do not drive, operate machinery or do other dangerous activities until you know how Levetiracetam affects you. Levetiracetam may make you dizzy or sleepy.

What are the possible side effects of Levetiracetam?

Levetiracetam 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 include:

The most common side effects seen in children who take Levetiracetam 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. 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.

How should I store Levetiracetam Oral Solution?
• Store Levetiracetam Oral Solution at room temperature, 59º to 86ºF (15ºC to 30ºC) away from heat and light.
• Keep Levetiracetam Oral Solution and all medicines out of the reach of children.

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

What are the ingredients of Levetiracetam?
Levetiracetam oral solution contains 100 mg of levetiracetam per mL. Inactive ingredients are acesulfame potassium, citric acid, flavor, glycerin, methylparaben, propylparaben, purified water, sodium citrate, and sorbitol solution.

Levetiracetam does not contain lactose or gluten. Levetiracetam Oral Solution does contain carbohydrates. The liquid is dye-free.

Rx Only

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


Manufactured by:
Silarx Pharmaceuticals, Inc.
Carmel, NY 10512 USA

Revised: 01/2014
 
Silarx Pharmaceuticals, Inc