Oxtellar XR

Oxcarbazepine is used with other medications to treat seizure disorders (epilepsy).

Read the Medication Guide provided by your pharmacist before you start using oxcarbazepine and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

Take this medication by mouth without food as directed by your doctor, usually once daily. It is very important to take this medication on an empty stomach, at least 1 hour before or 2 hours after food.

Swallow whole. Do not crush or chew extended-release tablets. Doing so can release all of the drug at once, increasing the risk of side effects.

The dosage is based on your medical condition, response to treatment, and other medications you may be taking. Children's dosage is also based on weight. To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor's instructions carefully. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

It is important to take all doses on time to keep the level of medication in your blood constant. Take doses at evenly spaced intervals. Do not skip doses.

Do not suddenly stop taking this drug without your doctor's approval since seizures may reoccur.

Tell your doctor if seizure control worsens.

Dizziness, drowsiness, fatigue, nausea, vomiting, or headache may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A small number of people who take anticonvulsants for any condition (such as seizure, bipolar disorder, pain) may experience depression, suicidal thoughts/attempts, or other mental/mood problems. Tell your doctor right away if you or your family/caregiver notice any unusual/sudden changes in your mood, thoughts, or behavior including signs of depression, suicidal thoughts/attempts, thoughts about harming yourself.

Tell your doctor right away if you have any serious side effects, including: loss of coordination, vision changes (such as double vision), rapid/uncontrollable eye movements, shaking (tremor), easy bleeding/bruising, unusual tiredness.

Get medical help right away if you have any very serious side effects, including: signs of infection (such as fever, swollen lymph nodes, sore throat that doesn't go away, cough), symptoms of low sodium level (severe nausea, extreme drowsiness, confusion, seizures).

Oxcarbazepine may rarely cause very serious (possibly fatal) skin reactions. Some people in certain ethnic groups (including people of Asian/South Asian descent) are at greater risk. Your doctor may order a blood test to measure your risk before prescribing this medication. If the blood test shows you are at greater risk, discuss the risks and benefits of oxcarbazepine and other treatment choices with your doctor. Such skin reactions have developed mostly within the first few months of treatment. Get medical help right away if you develop any of the following symptoms: skin rash/blisters/peeling, itching, or swelling. Ask your doctor or pharmacist for more details.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking oxcarbazepine, tell your doctor or pharmacist if you are allergic to it; or to carbamazepine; or to eslicarbazepine; or to other anti-seizure medications (such as fosphenytoin, phenobarbital, phenytoin, primidone); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, mineral imbalance (low level of sodium in the blood).

This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. However, since untreated seizures are a serious condition that can harm both a pregnant woman and her unborn baby, do not stop taking this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, immediately discuss with your doctor the benefits and risks of using this medication during pregnancy. Since birth control pills, patches, implants, and injections may not work if taken with this medication (see also Drug Interactions section), discuss reliable forms of birth control with your doctor.

This medication passes into breast milk but is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

A product that may interact with this drug is: orlistat.

This medication can speed up or slow down the removal of other medications from your body, which may affect how they work. Examples of affected drugs include cobicistat, elvitegravir, certain drugs used to treat chronic hepatitis C (such as simeprevir, sofosbuvir), rilpivirine, among others.

This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. Discuss with your doctor or pharmacist if you should use additional reliable birth control methods while using this medication. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well.

Tell your doctor or pharmacist if you are taking other products that cause drowsiness including alcohol, marijuana (cannabis), antihistamines (such as cetirizine, diphenhydramine), drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), and opioid pain relievers (such as codeine, hydrocodone).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

Oxcarbazepine is very similar to eslicarbazepine. Do not use medications containing eslicarbazepine while using oxcarbazepine.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

Do not share this medication with others.

Laboratory and/or medical tests (such as sodium levels, complete blood count) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.