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The following safety information outlines important warnings about the use of Trileptal (oxcarbazepine). Please read carefully and discuss any concerns with your healthcare provider.

• Low Blood Sodium Levels: Trileptal can lead to low sodium levels in the blood, typically within the first three months of treatment. While many do not show symptoms, it can be detected through blood tests. Symptoms such as weakness, confusion, headaches, or memory issues require immediate medical attention, as they may indicate a medical emergency. Those at higher risk include older adults and individuals taking other medications that may lower sodium levels.

• Severe Allergic and Skin Reactions: There is a possibility of severe allergic reactions, including life-threatening conditions like facial swelling or anaphylaxis. Individuals with allergies to carbamazepine (Tegretol) or carrying certain genetic markers, especially those of Asian descent, are at increased risk. Notify your healthcare provider if you have a known allergy to carbamazepine.

• Risk of Suicidal Thoughts: Trileptal may increase the risk of suicidal thoughts or behaviors. These can occur as soon as a week after beginning the medication. Seek immediate medical attention if you experience suicidal thoughts, anxiety, panic attacks, difficulty sleeping, or any unusual behavior. This risk is heightened in individuals with a history of depression or other mental health issues.

• Cognitive and Motor Impairments: Some patients may experience difficulties with speech, concentration, and movement. Trileptal can cause significant dizziness and sleepiness, affecting your ability to think, react, and focus. These effects may be intensified by alcohol or other medications, such as benzodiazepines and muscle relaxants. Avoid driving or engaging in activities that require full concentration until you understand how Trileptal affects you. Consult your healthcare provider if excessive sleepiness occurs.

• Increased Seizure Risk: While effective in controlling seizures, Trileptal may exacerbate them, particularly in children, though adults can be affected too. If you observe seizure activity, discontinue use and seek medical assistance immediately.

• Withdrawal Concerns: Abruptly stopping Trileptal can elevate seizure risk. Always consult your healthcare provider before discontinuing the medication. They will guide you in tapering off safely to reduce seizure risk.

Contraindications:

• Do not use Trileptal if you have a history of allergic reactions to Aptiom (eslicarbazepine), as this could pose serious health risks. Consult your healthcare provider if this applies to you.

Common side effects:

• Dizziness
• Nausea
• Headache
• Vomiting
• Diarrhea
• Runny nose
• Sore throat

Less common but important to monitor:

• Constipation
• Heartburn
• Poor balance or coordination
• Nervousness

Serious side effects:

• Severe allergic reactions
• Hives
• Rashes
• Blisters
• Fever
• Swelling of the lips or tongue
• Breathing difficulties
• Skin reddening
• Low blood sodium levels
• Fatigue
• Confusion
• Hallucinations
• Seizures
• Unconsciousness
• Depression
• Suicidal thoughts
• Serious skin reactions
• Peeling skin

Interactions with high risk of serious adverse effects and should be avoided:

• Eslicarbazepine
• Cabotegravir
• Doravirine
• Rilpivirine

Interactions with moderate risk that may require dose adjustment, closer monitoring, or timing changes:

• Alfentanil
• Amiodarone
• Benzhydrocodone
• Buprenorphine
• Cobicistat
• Codeine
• Elvitegravir
• Hydrocodone
• Orlistat

Interactions with low risk that usually do not require a change in therapy:

• Felodipine
• Ginkgo
• Lamotrigine
• Simvastatin
• Valproic Acid
• Verapamil