LEVETIRACETAM- levetiracetam tablet 
A-S Medication Solutions

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MEDICATION GUIDE

Levetiracetam (LEE-ve-tye-RA-se-tam) Tablets, USP

Read this Medication Guide before you start taking levetiracetam 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 prescription 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 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 tablets provided below. Tell your pharmacist immediately if you think you have been given the wrong medicine.

 

250 mg levetiracetam tablets, USP are blue colored, oval shaped, film-coated tablets debossed with breakline separating '250' and 'MG' on one side and '1014' on other side.

500 mg levetiracetam tablets, USP are yellow colored, oval shaped, film-coated tablets debossed with breakline separating '500' and 'MG' on one side and '1015' on other side.

750 mg levetiracetam tablets, USP are orange colored, oval shaped, film-coated tablets debossed with breakline separating '750' and 'MG' on one side and '1016' on other side.

1000 mg levetiracetam tablets, USP are white to off white, oval shaped, film-coated tablets debossed with breakline separating '1000' and 'MG' on one side and '1017' on other side.

Who should not take levetiracetam?

Do not take levetiracetam tablets if you are allergic to levetiracetam.

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 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?

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 tablets affect you. Levetiracetam tablets 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 tablets 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 tablets?

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. You can also get information about levetiracetam tablets by calling 1-800-912-9561.  

What are the ingredients of levetiracetam tablets?

Levetiracetam tablet, USP active ingredient: levetiracetam, USP

Inactive ingredients: colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, polyethylene glycol 400, povidone, sodium starch glycolate, talc, titanium dioxide, and additional agents listed below:

      250 mg tablets: FD&C Blue #2 Lake of indigo carmine

      500 mg tablets: Ferric oxide yellow

      750 mg tablets: Ferric oxide red and FD&C #6 lake of sunset yellow

Levetiracetam tablets do not contain lactose or gluten.

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

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Manufactured by:

TORRENT PHARMACEUTICALS LTD., Indrad-382 721, Dist. Mehsana, INDIA.

8067180                                                                                              Revised January 2018

OR

TORRENT PHARMACEUTICALS LTD., Bharuch-392130, INDIA.

8067428                                                                                              Revised January 2018

Manufactured For:

TORRENT PHARMA INC., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920.

Revised: 8/2018
A-S Medication Solutions