Oxcarbazepine

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY

PREGNANCY

LABOR & DELIVERY

NURSING MOTHERS

PEDIATRIC USE

GERIATRIC USE

OXCARBAZEPINE ADVERSE REACTIONS

DRUG ABUSE AND DEPENDENCE

OVERDOSAGE

DOSAGE & ADMINISTRATION

HOW SUPPLIED

STORAGE AND HANDLING

INFORMATION FOR PATIENTS

SPL MEDGUIDE

• ●     nausea

• ●     tiredness, lack of energy

• ●     headache

• ●     confusion

• ●     more frequent or more severe seizures.

• ●     swelling of your face, eyes, lips, or tongue

• ●     trouble swallowing or breathing

• ●     a skin rash

• ●     hives

• ●     fever, swollen glands, or sore throat that do not go away or come and go

• ●     painful sores in the mouth or around your eyes

• ●     yellowing of your skin or eyes

• ●     unusual bruising or bleeding

• ●     severe fatigue or weakness

• ●     severe muscle pain

• ●     frequent infections or infections that do not go away

• ●     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

• ●     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.

• ●     alone or with other medicines to treat partial seizures in adults.

• ●     alone to treat partial seizures in children 4 years and older.

• ●     with other medicines to treat partial seizures in children 2 years and older.

• ●      Do not take oxcarbazepine tablets if you are allergic to oxcarbazepine or any of the other ingredients in oxcarbazepine tablets. See the end of this leaflet for a complete list of ingredients in oxcarbazepine tablets.

• ●     Many people who are allergic to carbamazepine are also allergic to oxcarbazepine. Tell your healthcare provider if you are allergic to carbamazepine.

• ●     have or have had suicidal thoughts or actions, depression or mood problems

• ●     have liver problems

• ●     have kidney problems

• ●     are allergic to carbamazepine. Many people who are allergic to carbamazepine are also allergic to oxcarbazepine.

• ●     use birth control medicine. Oxcarbazepine tablets may cause your birth control medicine to be less effective. Talk to your healthcare provider about the best birth control method to use.

• ●     are pregnant or plan to become pregnant. Oxcarbazepine tablets may harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking oxcarbazepine tablets. You and your healthcare provider will decide if you should take oxcarbazepine tablets while you are pregnant.

• ●               If you become pregnant while taking oxcarbazepine tablets, talk to your healthcare provider about registering with the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The purpose of this registry is to collect information about the safety of antiepileptic medicine during pregnancy. You can enroll in this registry by calling 1-888-233-2334.

• ●

• ●      Do not stop taking oxcarbazepine tablets without talking to your healthcare provider. Stopping oxcarbazepine tablets suddenly can cause serious problems, including seizures that will not stop (status epilepticus).

• ●     Take oxcarbazepine tablets exactly as prescribed. Your healthcare provider may change your dose. Your healthcare provider will tell you how much oxcarbazepine to take.

• ●     Take oxcarbazepine tablets 2 times a day.

• ●     Take oxcarbazepine tablets with or without food.

• ●     If you take too much oxcarbazepine, call your healthcare provider or local Poison Control Center right away.

• ●      Do not drive, operate heavy machinery, or do other dangerous activities until you know how oxcarbazepine tablets affect you. Oxcarbazepine tablets may slow your thinking and motor skills.

• ●     Do not drink alcohol or take other drugs that make you sleepy or dizzy while taking oxcarbazepine tablets until you talk to your healthcare provider. Oxcarbazepine tablets taken with alcohol or drugs that cause sleepiness or dizziness may make your sleepiness or dizziness worse.

• ●     your seizures can happen more often or become worse

• ●     trouble concentrating

• ●     problems with your speech and language

• ●     feeling confused

• ●     feeling sleepy and tired

• ●     trouble walking and with coordination

• ●     dizziness

• ●     sleepiness

• ●     double vision

• ●     tiredness

• ●     nausea

• ●     vomiting

• ●     problems with vision

• ●     stomach pain

• ●     trembling

• ●     upset stomach

• ●     problems with walking and coordination (unsteadiness)

• ●     rash

• ●     infections (especially in children)

• ●      Store at 20to 25(68to 77to 30(59to 86

• ●               Keep oxcarbazepine tablets dry.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION