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This document provides essential safety information related to the use of Lamotrigine (Lamictal). It is crucial to understand the potential risks and necessary precautions. Discuss any concerns with your healthcare provider.

• Severe Skin Reactions and Allergic Reactions: Lamotrigine can cause severe skin reactions, including rashes that may require hospitalization. The risk increases if taken with divalproex (Depakote) or valproic acid, if doses are too high, or if increased too quickly. Children face a higher risk. Symptoms can appear anytime but are most common within 2 to 8 weeks of starting treatment. Seek medical help immediately if you notice a rash, blistering, peeling skin, painful sores, facial swelling, or breathing difficulties.

• Overactive Immune System (HLH): Some patients may develop hemophagocytic lymphohistiocytosis, a rare but life-threatening immune condition. Symptoms, which can appear within 8 to 24 days of starting Lamotrigine, include fever, rash, abdominal pain or swelling, dark urine, or jaundice. Immediate medical attention is necessary if these symptoms occur.

• Irregular Heartbeat: This medication may cause irregular heartbeats, especially in individuals with a history of heart disease or those at risk for coronary artery disease (CAD). Inform your healthcare provider if you have any heart conditions or are taking medications affecting heart rhythm.

• Suicidal Thoughts and Behavior: There is a potential increase in suicidal thoughts or behaviors, particularly within the first week of treatment. This risk is higher for those with a history of such thoughts or actions. It's important for friends and family to monitor for any mood changes, and to contact a healthcare provider if suicidal thoughts or actions occur.

• Meningitis: Although rare, Lamotrigine may increase the risk of meningitis, an inflammation of the brain lining. Symptoms can appear 1 to 45 days after starting treatment and include headache, stiff neck, fever, chills, nausea, rash, drowsiness, confusion, or light sensitivity. Seek medical care immediately if symptoms arise.

• Withdrawal Seizures: Abruptly stopping Lamotrigine can lead to withdrawal seizures. Do not discontinue the medication without consulting your healthcare provider, who can guide a gradual reduction in dosage.

• Eye Problems: Long-term use of Lamotrigine may pose a risk for eye problems due to its melanin-binding properties. Report any vision changes to your healthcare provider, who may recommend an eye examination.

• Drug Interactions: Certain medications can alter how Lamotrigine is processed in your body, affecting its efficacy and increasing side effects. Similarly, Lamotrigine can affect other medications. Inform your healthcare provider about all medications you are taking to manage these interactions effectively.

Always follow your healthcare provider's guidance and report any adverse symptoms promptly for appropriate management.

Common side effects:

• Dizziness
• Headache
• Double vision
• Loss of coordination
• Nausea
• Blurry vision
• Sleepiness
• Stuffy nose
• Sore throat
• Rash

Less common but important to monitor:

• Vomiting
• Tremor
• Feeling tired
• Diarrhea

Serious side effects:

• Indigestion
• Severe vomiting
• Constipation
• Diarrhea
• Dry mouth
• Cough
• Flu-like symptoms
• Trouble sleeping
• Back pain
• Worsening seizures
• Anxiety

When taking Lamictal ODT (lamotrigine), it's important to be aware of potential interactions with other medications and substances, as these can affect how the drug works or increase the risk of side effects.

Medications That May Increase Lamotrigine Levels:

• Valproate (Valproic Acid): This medication can more than double lamotrigine concentrations in the blood, potentially increasing the risk of side effects.

Medications That May Decrease Lamotrigine Levels:

• Carbamazepine, Phenytoin, Phenobarbital, Primidone, and Rifampin: These drugs can reduce lamotrigine concentrations by approximately 40%, which may decrease its effectiveness.

• Estrogen-Containing Oral Contraceptives: Birth control pills with estrogen can lower lamotrigine levels by about 50%, potentially reducing its efficacy.

• Protease Inhibitors (e.g., Lopinavir/Ritonavir, Atazanavir/Ritonavir): These medications can decrease lamotrigine exposure by approximately 50% and 32%, respectively.

Medications That May Be Affected by Lamotrigine:

• Hormonal Contraceptives: Lamotrigine may decrease the effectiveness of hormonal birth control methods, such as pills, patches, or rings, potentially leading to unintended pregnancy.

Other Considerations:

• Alcohol: Consuming alcohol while taking lamotrigine can enhance side effects like dizziness, drowsiness, and difficulty concentrating. It's advisable to avoid or limit alcohol intake during treatment.

• Central Nervous System Depressants: Combining lamotrigine with other CNS depressants, such as certain antihistamines, sleep aids, or muscle relaxants, can increase drowsiness and impair thinking or motor skills.

Always inform your healthcare provider about all medications, supplements, and substances you are using to ensure safe and effective use of Lamictal ODT.