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P1512013 levetiracetam os mg

Levetiracetam Oral Solution USP
(lee'' va tye ra' se tam)
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
Before taking your medicine, make sure you have received the levetiracetam oral solution?
correct medicine. Compare the name above with the name on your Like other antiepileptic drugs, levetiracetam oral solution may
bottle and the appearance of your medicine with the description of cause suicidal thoughts or actions in a very small number of
levetiracetam oral solution provided below. Tell your pharmacist people, about 1 in 500 people taking it.
immediately if you think you have been given the wrong medicine.
Call a healthcare provider right away if you have any of these
Levetiracetam oral solution is a clear, colorless grape flavored liquid.
symptoms, especially if they are new, worse, or worry you:
What should I tell my healthcare provider before starting
• thoughts about suicide or dying levetiracetam oral solution?
• attempts to commit suicide Before taking levetiracetam oral solution, tell your healthcare provider about all of your medical conditions, including if you: • new or worse depression • have or have had depression, mood problems or suicidal • new or worse anxiety thoughts or behavior • feeling agitated or restless • have kidney problems • panic attacks • are pregnant or planning to become pregnant. It is not known if • trouble sleeping (insomnia) levetiracetam oral solution will harm your unborn baby. You and • new or worse irritability your healthcare provider will have to decide if you should take levetiracetam oral solution while you are pregnant. If you become • acting aggressive, being angry, or violent pregnant while taking levetiracetam oral solution, talk to your • acting on dangerous impulses healthcare provider about registering with the North American • an extreme increase in activity and talking (mania) Antiepileptic Drug Pregnancy Registry. You can enroll in this • other unusual changes in behavior or mood registry by calling 1-888-233-2334. The purpose of this registry is to collect information about the safety of levetiracetam oral Do not stop levetiracetam oral solution without first talking to a
solution and other antiepileptic medicine during pregnancy.
• are breast feeding. Levetiracetam can pass into your milk and may • Stopping levetiracetam oral solution suddenly can cause serious harm your baby. You and your healthcare provider should discuss problems. Stopping a seizure medicine suddenly can cause whether you should take levetiracetam oral solution or breast- seizures that will not stop (status epilepticus).
feed; you should not do both.
• Suicidal thoughts or actions can be caused by things other than Tell your healthcare provider about all the medicines you take, medicines. If you have suicidal thoughts or actions, your including prescription and nonprescription medicines, vitamins, and healthcare provider may check for other causes.
herbal supplements. Do not start a new medicine without first talking How can I watch for early symptoms of suicidal thoughts and
with your healthcare provider.
Know the medicines you take. Keep a list of them to show your • Pay attention to any changes, especially sudden changes, in healthcare provider and pharmacist each time you get a new mood, behaviors, thoughts, or feelings.
• Keep all follow-up visits with your healthcare provider as How should I take levetiracetam oral solution?
Take levetiracetam oral solution exactly as prescribed.
• Call your healthcare provider between visits as needed, especially if you are worried about symptoms.
• Your healthcare provider will tell you how much levetiracetam oral solution to take and when to take it. Levetiracetam oral solution is What is levetiracetam oral solution?
usually taken twice a day. Take levetiracetam oral solution at the Levetiracetam oral solution is a prescription medicine taken by same times each day.
mouth that is used with other medicines to treat: • Your healthcare provider may change your dose. Do not change • partial onset seizures in people 1 month of age and older with your dose without talking to your healthcare provider.
• Take levetiracetam oral solution with or without food.
• myoclonic seizures in people 12 years of age and older with • If your healthcare provider has prescribed levetiracetam oral juvenile myoclonic epilepsy solution, be sure to ask your pharmacist for a medicine dropper or • primary generalized tonic-clonic seizures in people 6 years of age medicine cup to help you measure the correct amount of and older with certain types of generalized epilepsy.
levetiracetam oral solution. Do not use a household teaspoon. It is not known if levetiracetam oral solution is safe or effective in Ask your pharmacist for instructions on how to use the children under 1 month of age.
measuring device the right way.
A/s: 200 x 260 mm n Black 22.03.2016 & 05.30 pm A/s : 200 x 260 mm Supersedes Code : P1510827 • If you miss a dose of levetiracetam oral solution, take it as soon as How should I store levetiracetam oral solution?
you remember. If it is almost time for your next dose, just skip the • Store levetiracetam oral solution at room temperature, 15° to missed dose. Take the next dose at your regular time. Do not take
30°C (59° to 86°F) away from heat and light. two doses at the same time.
• Keep levetiracetam oral solution and all medicines out of the
• If you take too much levetiracetam oral solution, call your local reach of children.
Poison Control Center or go to the nearest emergency room right away.
General information about levetiracetam oral solution
What should I avoid while taking levetiracetam oral solution?
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use levetiracetam oral solution Do not drive, operate machinery or do other dangerous activities for a condition for which it was not prescribed. Do not give until you know how levetiracetam oral solution affects you. levetiracetam oral solution to other people, even if they have the Levetiracetam oral solution may make you dizzy or sleepy.
same symptoms that you have. It may harm them.
What are the possible side effects of levetiracetam oral solution?
This Medication Guide summarizes the most important information • See "What is the most important information I should know
about levetiracetam oral solution. If you would like more about levetiracetam oral solution?"
information, talk with your healthcare provider. You can ask your Levetiracetam oral solution can cause serious side effects.
pharmacist or healthcare provider for information about levetiracetam oral solution that is written for health professionals. Call your healthcare provider right away if you have any of these You can also get information about levetiracetam oral solution by • mood and behavior changes such as aggression, agitation, anger, What are the ingredients of levetiracetam oral solution?
anxiety, apathy, mood swings, depression, hostility, and irritability. A few people may get psychotic symptoms such as Active ingredient: levetiracetam hallucinations (seeing or hearing things that are really not there), Inactive ingredients: maltitol solution, glycerin, propylene glycol, delusions (false or strange thoughts or beliefs) and unusual methylparaben, propylparaben, citric acid monohydrate, sodium citrate (dihydrate), acesulfame potassium, ammonium • extreme sleepiness, tiredness, and weakness glycyrrhizinate, artificial grape flavor, and purified water.
• problems with muscle coordination (problems walking and Levetiracetam oral solution does not contain lactose or gluten. Levetiracetam oral solution does contain carbohydrates. The liquid is dye-free.
• a skin rash. Serious skin rashes can happen after you start taking levetiracetam oral solution. There is no way to tell if a mild rash This Medication Guide has been approved by the U.S. Food and Drug will become a serious reaction.
The most common side effects seen in people who take Medication Guides available at www.northstarrxllc.com/products
levetiracetam oral solution include: or call 1-800-206-7821.
Manufactured for: Northstar Rx LLC Memphis, TN 38141.
Toll Free: 1-800-206-7821 Aurobindo Pharma Limited Hyderabad-500 090, India.
The most common side effects seen in children who take levetiracetam oral solution include, in addition to those listed above: M.L.No.: 19/HD/AP/95/F/R • 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. 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.

Source: http://www.northstarrxllc.com/medguides/Levetiracetam%20Oral%20Solution,%20USP.pdf