ELEPSIA XR - levetiracetam tablet, extended release
Sun Pharma Advanced Research Company Limited
Read this Medication Guide before you start taking ELEPSIA XR 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 ELEPSIA XR?
Like other antiepileptic drugs, ELEPSIA XR 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 ELEPSIA XR without first talking to a healthcare provider.
How can I watch for early symptoms of suicidal thoughts and actions?
What is ELEPSIA XR?
ELEPSIA XR is a prescription medicine taken by mouth that is used with other medicines to treat partial onset seizures in people 12 years of age and older.
It is not known if ELEPSIA XR is safe or effective in people under 12 years of age.
Who should not take ELEPSIA XR?
Do not take ELEPSIA XR if you are allergic to levetiracetam.
What should I tell my healthcare provider before starting ELEPSIA XR?
Before taking ELEPSIA XR, 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 over -the-counter 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 ELEPSIA XR?
Take ELEPSIA XR exactly as your healthcare provider tells you take it.
What should I avoid while taking ELEPSIA XR?
Do not drive, operate machinery or do other dangerous activities until you know how ELEPSIA XR affects you. ELEPSIA XR may make you dizzy or sleepy.
What are the possible side effects of ELEPSIA XR?
See “What is the most important information I should know about ELEPSIA XR?”
Call your healthcare provider right away if you have any of these symptoms:
Common side effects seen in people who take ELEPSIA XR:
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 ELEPSIA XR. 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 ELEPSIA XR?
Store ELEPSIA XR at room temperature, between 68°F to 77°F (20°C to 25°C) away from light.
Keep ELEPSIA XR and all medicines out of the reach of children.
General information about the safe and effective use of ELEPSIA XR.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ELEPSIA XR for a condition for which it was not prescribed. Do not give ELEPSIA XR 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 ELEPSIA XR that is written for health professionals.
What are the ingredients of ELEPSIA XR?
Active ingredient: levetiracetam
Inactive ingredients: amino methyacrylate copolymer, colloidal silicon dioxide, crospovidone, dibutyl sebacate, ethyl cellulose, FD&C Blue #1 aluminum lake, hypromellose, magnesium stearate, polyethylene glycol, polysorbate 20, polysorbate 80, polyvinyl alcohol, povidone, silicified microcrystalline cellulose, sodium lauryl sulfate, talc, and triethyl citrate. The imprinting ink contains ammonium hydroxide, iron oxide black, N-butyl alcohol, propylene glycol, and shellac glaze.
Manufactured for Sun Pharma Global FZE
by Sun Pharmaceutical Industries, Ltd.
Halol 389350, Gujarat, India
Sun Pharmaceutical Industries, Inc.
Cranbury, NJ 08512
Copyright 2020, Sun Pharma Global FZE
All rights reserved
For more information, call Sun Pharmaceutical Industries, Inc. at 833-SUN-INFO (833-786-4636).
This Medication Guide has been approved by the U.S. Food and Drug Administration.