TIRATAM 500 MG ( LEVETIRACETAM ) 30 FILM-COATED TABLETS

WHAT IS LEVETIRACETAM?
Levetiracetam is used to treat partial onset seizures in adults and children who are at least 1 month old. The Spritam brand of this medicine is not for use in children younger than 4 years old or children who weigh less than 44 pounds.

Levetiracetam is also used to treat tonic-clonic seizures in people who are at least 6 years old, and myoclonic seizures in people who are at least 12 years old.

Levetiracetam may also be used for purposes not listed in this medication guide.

WHAT ARE THE POSSIBLE SIDE EFFECTS OF LEVETIRACETAM?
Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, depression, anxiety, panic attacks, trouble sleeping, or if you feel agitated, hostile, irritable, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

unusual changes in mood or behavior (unusual risk-taking behavior, being irritable or talkative);
confusion, hallucinations, loss of balance or coordination;
extreme drowsiness, feeling very weak or tired;
problems with walking or movement;
the first sign of any skin rash, no matter how mild;
easy bruising, unusual bleeding; or
fever, chills, weakness, or other signs of infection.
Common side effects may include:

dizziness, drowsiness, tiredness;
weakness;
feeling aggressive or irritable;
loss of appetite;
stuffy nose; or
infection.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT LEVETIRACETAM?
Some people have thoughts about suicide when first taking this medicine. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

Keppra Patient Information including How Should I Take

WHAT SHOULD I DISCUSS WITH MY HEALTHCARE PROVIDER BEFORE TAKING LEVETIRACETAM?
You should not use levetiracetam if you are allergic to it.

Tell your doctor if you have ever had:

kidney disease (or if you are on dialysis);
depression or other mood problems;
mental illness or psychosis; or
suicidal thoughts or actions.
You may have thoughts about suicide while taking this medicine. Your doctor should check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Follow your doctor's instructions about taking seizure medication if you are pregnant. Seizure control is very important during pregnancy, and having a seizure could harm both mother and baby. Your dose needs may be different during pregnancy. Do not start or stop taking this medicine without your doctor's advice, and tell your doctor right away if you become pregnant.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of levetiracetam on the baby.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Do not give this medicine to a child without medical advice.

HOW SHOULD I TAKE LEVETIRACETAM?
Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Take the medicine at the same time each day, with or without food.

Levetiracetam doses are based on weight in children. Your child's dose needs may change if the child gains or loses weight.

Your dose needs may change if you switch to a different brand, strength, or form of this medicine. Avoid medication errors by using only the form and strength your doctor prescribes.

Measure liquid medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Swallow the extended-release tablet whole and do not crush, chew, or break it.

To take the Spritam dissolvable tablet:

Remove a tablet from the package only when you are ready to take the medicine.
Use dry hands to remove the tablet and place it on your tongue. Then take a sip of liquid and hold it in your mouth.
Do not swallow the tablet whole. Allow it to dissolve in your mouth with the sip of liquid.
Swallow only after the tablet has completely dissolved, which should take less than 30 seconds.
You should not stop using levetiracetam suddenly, unless your doctor tells you to stop the medicine because of a serious side effect. Stopping suddenly may cause increased seizures. Follow your doctor's instructions very carefully.

Use all seizure medications as directed and read all medication guides you receive. Do not change your dose or dosing schedule without your doctor's advice.

In case of emergency, wear or carry medical identification to let others know you use seizure medication.

Your kidney function may need to be tested often.

Store at room temperature away from moisture, heat, and light.

Keppra Patient Information including If I Miss a Dose

WHAT HAPPENS IF I MISS A DOSE?
Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Get your prescription refilled before you run out of medicine completely.

WHAT HAPPENS IF I OVERDOSE?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include extreme drowsiness, agitation, aggression, shallow breathing, weakness, or fainting.

WHAT SHOULD I AVOID WHILE TAKING LEVETIRACETAM?
Drinking alcohol with this medicine can cause side effects and may also increase the risk of seizures.

Avoid driving or hazardous activity until you know how this medicine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

WHAT OTHER DRUGS WILL AFFECT LEVETIRACETAM?
Other drugs may affect levetiracetam, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

WHERE CAN I GET MORE INFORMATION?
Your pharmacist can provide more information about levetiracetam.

REMEMBER, KEEP THIS AND ALL OTHER MEDICINES OUT OF THE REACH OF CHILDREN, NEVER SHARE YOUR MEDICINES WITH OTHERS, AND USE THIS MEDICATION ONLY FOR THE INDICATION PRESCRIBED.

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