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?
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
- Stopping levetiracetam 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.
- 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.
Levetiracetam oral solution is a prescription medicine taken by mouth that is used with other medicines to treat:
- 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.
- 1 month of age to treat partial-onset seizures
- 12 years of age to treat myoclonic seizures
- 6 years of age to treat generalized tonic-clonic seizures
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.
Tell your pharmacist immediately if you think you have been given the wrong medicine.
Do not take levetiracetam oral solution if you are allergic to levetiracetam.
Before taking levetiracetam, 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 will harm your unborn baby. You and your healthcare provider will have to decide if you should take levetiracetam while you are pregnant. If you become pregnant while taking levetiracetam, 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 and other antiepileptic medicine during pregnancy.
- are breastfeeding or plan to breastfeed. Levetiracetam can pass into your breast milk. It is not known if the levetiracetam that passes into your breast milk can harm your baby. Talk to your doctor about the best way to feed your baby while you receive levetiracetam..
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Do not start a new medicine without first talking with your healthcare provider.
How should I take levetiracetam oral solution?
- Take levetiracetam exactly as your healthcare provider tells you to take it.
- Your healthcare provider will tell you how much levetiracetam to take and when to take it. Levetiracetam is usually taken 2 times each day.
- Your healthcare provider may change your dose. Do not change your dose without talking to your healthcare provider.
- Take levetiracetam with or without food.
- If your healthcare provider has prescribed levetiracetam oral solution, be sure to ask your pharmacist for a medicine dropper or medicine cup to help you measure the correct amount of levetiracetam oral solution. Do not use a household teaspoon. Ask your pharmacist for instructions on how to use the measuring device the right way.
- If you take too much levetiracetam, call your local Poison Control Center or go to the nearest emergency room right away.
Do not drive, operate machinery or do other dangerous activities until you know how levetiracetam affects you. Levetiracetam may make you dizzy or sleepy.
Levetiracetam can cause serious side effects including:
- 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
- allergic reactions such as swelling of the face, lips, eyes, tongue, and throat, trouble swallowing or breathing, and hives.
- a skin rash. Serious skin rashes can happen after you start taking levetiracetam. There is no way to tell if a mild rash will become a serious reaction.
- problems with muscle coordination (problems walking and moving)
- acting aggressive
- decreased appetite
- nasal congestion
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 at room temperature, 59°F to 86°F (15°C to 30°C) away from heat and light.
- Keep levetiracetam and all medicines out of the reach of children.
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.
You can ask your pharmacist or healthcare provider for information about levetiracetam that is written for health professionals.
Inactive ingredients: ammonium glycyrrhizinate, citric acid, glycerin, maltitol solution, methylparaben, potassium acesulfame, propylparaben, purified water, sodium citrate dihydrate and natural and artificial flavor.
Levetiracetam does not contain lactose or gluten. Levetiracetam oral solution does contain carbohydrates. The liquid is dye-free.
This Medication Guide has been approved by the US Food and Drug Administration.
Product No.: 8831
Wockhardt USA, LLC.
Parsippany, NJ 07054
Morton Grove Pharmaceuticals, Inc.
Morton Grove, IL 60053
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