MEDICATION GUIDE
Levetiracetam Tablets, USP
Rx Only
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:
- 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
without first talking to a healthcare provider.
- 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.
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?
Levetiracetam is a prescription medicine taken by mouth that is used with
other medicines to treat:
- partial onset seizures in people 1 month 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 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.
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:
- 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 these
registries is to collect information about the safety of levetiracetam and other
antiepileptic medicine during pregnancy.
- are breast feeding. Levetiracetam can pass into your milk and may harm your
baby. You and your healthcare provider should discuss whether you should take
levetiracetam 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?
Take levetiracetam exactly as prescribed.
- Your healthcare provider will tell you how much levetiracetam to take and
when to take it. Levetiracetam is usually taken twice a day. Take levetiracetam
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 with or without food.
- Swallow the tablets whole. Do not chew or crush tablets. Ask your healthcare
provider for levetiracetam oral solution if you cannot swallow tablets.
- 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 miss a dose of levetiracetam, 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, call your local Poison Control Center or
go to the nearest emergency room right away.
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?
- See "What is the most important information I should know about
levetiracetam?"
Levetiracetam 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. 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 include:
- sleepiness
- weakness
- infection
- dizziness
The most common side effects seen in children who take
levetiracetam tablets 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. 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?
- Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° -
86°F). [See USP Controlled Room Temperature] away from heat and light.
-
Keep levetiracetam tablets and all medicines out of the
reach of children.
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 1-269-544-2299.
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.
Manufactured by:
TORRENT PHARMACEUTICALS LTD., Indrad-382 721, Dist. Mehsana, INDIA.
For:
TORRENT PHARMA INC., 5380 Holiday Terrace, Suite 40, Kalamazoo,
Michigan 49009.
8033110 Revised February 2012
Physicians Total Care, Inc.