Trileptal

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IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This drug may also be used for certain types of nerve pain (such as trigeminal neuralgia).

Before taking oxcarbazepine, tell your doctor or pharmacist if you are allergic to it; or to carbamazepine or 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).

Younger children may be more sensitive to the side effects of this drug, especially infections.

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, discuss with your doctor right away the benefits and risks of using this medication during pregnancy. Since hormonal birth control 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 breastfeeding.

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 cabotegravir, cobicistat, elvitegravir, 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 reliable backup 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 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Lab and/or medical tests (such as sodium levels, complete blood count) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

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

Shake the bottle well before each dose. Carefully measure the dose using the oral measuring syringe provided. Do not use a household spoon because you may not get the correct dose. The medication may be swallowed directly from the oral syringe or mixed in a small glass of water. Take this medication by mouth with or without food as directed by your doctor, usually twice daily.

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).

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.

Do not stop taking this medication without consulting your doctor. Some conditions (such as seizures) may become worse when this drug is suddenly stopped. Your dose may need to be gradually decreased.

Tell your doctor if your seizures get worse.

Dizziness, drowsiness, tiredness, nausea/vomiting, stomach/abdominal pain, headache, trouble sleeping, or constipation may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor 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 sore throat that doesn't go away, fever, swollen lymph nodes, chills), 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 you start this medication. If the blood test shows you are at greater risk, your doctor should discuss the risks and benefits of oxcarbazepine and other treatment choices with you. Such skin reactions have developed mostly within the first few months of treatment. Get medical help right away if you develop symptoms of a serious skin reaction such as 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/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program.

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