LEVETIRACETAM - levetiracetam solution 
Sandoz Inc.

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SPL MEDGUIDE

Levetiracetam Oral Solution USP, 100 mg/mL

Read this Medication Guide before you start taking levetiracetam oral solution USP, 100 mg/mL 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 USP, 100 mg/mL?

Like other antiepileptic drugs, levetiracetam oral solution USP, 100 mg/mL 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:

●   thoughts about suicide or dying
●   attempts to commit suicide
●   new or worse depression
●   new or worse anxiety
●   feeling agitated or restless
●   panic attacks
●   trouble sleeping (insomnia)
●   new or worse irritability
●   acting aggressive, being angry, or violent
●   acting on dangerous impulses
●   an extreme increase in activity and talking (mania)
●   other unusual changes in behavior or mood

Do not stop levetiracetam oral solution USP, 100 mg/mL without first talking to a healthcare provider.

●  Stopping levetiracetam oral solution USP, 100 mg/mL suddenly can cause serious problems. Stopping a     seizure medicine suddenly can cause seizures that will not stop (status epilepticus).
●  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?

●  Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.
●  Keep all follow-up visits with your healthcare provider as scheduled.
●  Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

What is levetiracetam oral solution USP, 100 mg/mL?

Levetiracetam oral solution USP, 100 mg/mL is a prescription medicine taken by mouth that is used with other medicines to treat:

●  partial onset seizures in people 4 years of age and older with epilepsy
●  myoclonic seizures in people 12 years of age and older with juvenile myoclonic epilepsy
●  primary generalized tonic-clonic seizures in people 6 years of age and older with certain types of generalized epilepsy.

It is not known if levetiracetam oral solution USP, 100 mg/mL 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 USP, 100 mg/mL 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 USP, 100 mg/mL?

Before taking levetiracetam oral solution USP, 100 mg/mL  tell your healthcare provider about all of your medical conditions, including if you:

●  have or have had depression, mood problems or suicidal thoughts or behavior
●  have kidney problems
●  are pregnant or planning to become pregnant.  It is not known if levetiracetam oral solution USP, 100 mg/mL will harm your unborn baby.  You and your healthcare provider will have to decide if you should take levetiracetam oral solution USP, 100 mg/mL while you  are pregnant.  If you become pregnant while taking levetiracetam oral solution USP, 100 mg/mL  talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry.  You can enroll in this registry by calling 1-888-233-2334.   The purpose of this registry is to collect information about the safety of levetiracetam oral solution USP, 100 mg/mL and other antiepileptic medicine during pregnancy.
●  are breast feeding. Levetiracetam oral solution USP, 100 mg/mL can pass into your milk and may harm your baby.  You and your healthcare provider should discuss whether you should take levetiracetam oral solution USP, 100 mg/mL or breast-feed; you should not do both.

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 USP, 100 mg/mL?

Take levetiracetam oral solution USP, 100 mg/mL exactly as prescribed.

● Your healthcare provider will tell you how much levetiracetam oral solution USP, 100 mg/mL to take and when to take it.  Levetiracetam oral solution USP, 100 mg/mL is usually taken twice a day. Take levetiracetam oral solution USP, 100 mg/mL at the same times each day.
● Your healthcare provider may change your dose.  Do not change your dose without talking to your healthcare provider.
● Take levetiracetam oral solution USP, 100 mg/mL with or without food.
● If your healthcare provider has prescribed levetiracetam oral solution USP, 100 mg/mL be sure to ask your pharmacist for a medicine dropper or medicine cup to help you measure the correct amount of levetiracetam oral solution USP, 100 mg/mL. Do not use a household teaspoon. Ask your pharmacist for instructions on how to use the measuring device the right way.
● If you miss a dose of levetiracetam oral solution USP, 100 mg/mL take it as soon as you remember.  If it is almost time for your next dose, just skip the missed dose. Take the next dose at your regular time.  Do not take two doses at the same time.
● If you take too much levetiracetam oral solution USP, 100 mg/mL call your local Poison Control Center or go to the nearest emergency room right away.

What should I avoid while taking levetiracetam oral solution USP, 100 mg/mL?

Do not drive, operate machinery or do other dangerous activities until you know how levetiracetam oral solution USP, 100 mg/mL affects you. Levetiracetam oral solution USP, 100 mg/mL may make you dizzy or sleepy.

What are the possible side effects of levetiracetam oral solution USP, 100 mg/mL?

● See “What is the most important information I should know about levetiracetam oral solution USP, 100 mg/mL?”

Levetiracetam oral solution USP, 100 mg/mL can cause serious side effects.

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

● mood and behavior changes such as aggression, agitation, anger, anxiety, apathy, mood swings, depression, hostility, and irritability.  A few people may get psychotic symptoms such as hallucinations (seeing or hearing things that are really not there), delusions (false or strange thoughts or beliefs) and unusual behavior. 
● extreme sleepiness, tiredness, and weakness
● problems with muscle coordination (problems walking and moving)
● a skin rash.  Serious skin rashes can happen after you start taking levetiracetam oral solution USP, 100 mg/mL.  There is no way to tell if a mild rash will become a serious reaction.

The most common side effects seen in people who take levetiracetam oral solution USP, 100 mg/mL include:

● sleepiness
● weakness
● infection
● dizziness

The most common side effects seen in children who take levetiracetam oral solution USP, 100 mg/mL include, in addition to those listed above:

● tiredness
● acting aggressive
● nasal congestion
● decreased appetite
● irritability

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 USP, 100 mg/mL.  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 USP, 100 mg/mL?

● Store levetiracetam oral solution USP, 100 mg/mL at room temperature, 59°F to 86°F (15°C to 30°C) away from heat and light.
Keep levetiracetam oral solution USP, 100 mg/mL and all medicines out of the reach of children.

General information about levetiracetam oral solution USP, 100 mg/mL.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.  Do not use levetiracetam oral solution USP, 100 mg/mL for a condition for which it was not prescribed.  Do not give levetiracetam oral solution USP, 100 mg/mL 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 USP, 100 mg/mL. 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 USP, 100 mg/mL that is written for health professionals.

What are the ingredients of levetiracetam oral solution USP, 100 mg/mL?

Active ingredient: levetiracetam

Inactive ingredients: ammonium glycyrrhizinate, citric acid monohydrate, glycerin, maltitol solution, methylparaben, potassium acesulfame, propylparaben, purified water, sodium citrate dihydrate and natural and artificial flavor.

Levetiracetam oral solution USP, 100 mg/mL does not contain lactose or gluten. Levetiracetam oral solution USP, 100 mg/mL 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 tablets and 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 by

TOLMAR Inc.
Fort Collins, CO 80526 for
Sandoz Inc.
Princeton, NJ 08540

44512 Rev. 6 03/14

Revised: 05/2014
 
Sandoz Inc.