Levetiracetam

REMEDYREPACK INC.

FULL PRESCRIBING INFORMATION: CONTENTS*

• LEVETIRACETAM DESCRIPTION
• CLINICAL PHARMACOLOGY
• PHARMACOKINETICS
• USE IN SPECIFIC POPULATIONS
• CLINICAL STUDIES
• INDICATIONS & USAGE
• LEVETIRACETAM CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
• INFORMATION FOR PATIENTS
• LABORATORY TESTS
• DRUG INTERACTIONS
• CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
• PREGNANCY
• LABOR & DELIVERY
• NURSING MOTHERS
• PEDIATRIC USE
• GERIATRIC USE
• LEVETIRACETAM ADVERSE REACTIONS
• DRUG ABUSE AND DEPENDENCE
• OVERDOSAGE
• DOSAGE & ADMINISTRATION
• HOW SUPPLIED
• STORAGE AND HANDLING
• SPL MEDGUIDE
• PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

FULL PRESCRIBING INFORMATION

LEVETIRACETAM DESCRIPTION

CLINICAL PHARMACOLOGY

PHARMACOKINETICS

USE IN SPECIFIC POPULATIONS

CLINICAL STUDIES

INDICATIONS & USAGE

LEVETIRACETAM CONTRAINDICATIONS

WARNINGS

PRECAUTIONS

INFORMATION FOR PATIENTS

LABORATORY TESTS

DRUG INTERACTIONS

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY

PREGNANCY

LABOR & DELIVERY

NURSING MOTHERS

PEDIATRIC USE

GERIATRIC USE

LEVETIRACETAM ADVERSE REACTIONS

DRUG ABUSE AND DEPENDENCE

OVERDOSAGE

DOSAGE & ADMINISTRATION

HOW SUPPLIED

STORAGE AND HANDLING

SPL MEDGUIDE

• ●     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 TABLETS 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.

• ●     Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

• ●     partial onset seizures in people 4 years of age and older with epilepsy

• ●     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 TABLETS will harm your unborn baby. You and your healthcare provider will have to decide if you should take LEVETIRACETAM TABLETS while you are pregnant. If you become pregnant while taking LEVETIRACETAM TABLETS, 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.

• ●     are breast feeding. LEVETIRACETAM TABLETS can pass into your milk and may harm your baby. You and your healthcare provider should discuss whether you should take LEVETIRACETAM TABLETS or breast-feed; you should not do both.

• ●     Your healthcare provider will tell you how much LEVETIRACETAM TABLETS to take and when to take it. LEVETIRACETAM TABLETS is usually taken twice a day. Take LEVETIRACETAM TABLETS 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 TABLETS with or without food.

• ●     Swallow the tablets whole. Do not chew or crush tablets.

• ●     If you miss a dose of LEVETIRACETAM TABLETS, 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 TABLETS, call your local Poison Control Center or go to the nearest emergency room right away.

• ●     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)

• ●     sleepiness

• ●     weakness

• ●     dizziness

• ●     infection

• ●     accidental injury

• ●     irritability

• ●     hostility

• ●     Store LEVETIRACETAM TABLETS at room temperature away from heat and light.

• ●      Keep LEVETIRACETAM TABLETS and all medicines out of the reach of children.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION