Patients and caregivers should be informed of the availability of a Medication Guide, and they should be instructed to read the Medication Guide prior to taking Trileptal. 

Patients should be advised that Trileptal may reduce the serum sodium concentrations especially if they are taking other medications that can lower sodium. Patients should be advised to report symptoms of low sodium like nausea, tiredness, lack of energy, confusion, and more frequent or more severe seizures [see Warnings and Precautions (5.1)].

Anaphylactic reactions and angioedema may occur during treatment with Trileptal. Patients should be advised to report immediately signs and symptoms suggesting angioedema (swelling of the face, eyes, lips, tongue or difficulty in swallowing or breathing) and to stop taking the drug until they have consulted with their physician [see Warnings and Precautions (5.2)].

Patients who have exhibited hypersensitivity reactions to carbamazepine should be informed that approximately 25%-30% of these patients may experience hypersensitivity reactions with Trileptal. Patients should be advised that if they experience a hypersensitivity reaction while taking Trileptal they should consult with their physician immediately [see Warnings and Precautions (5.3)].

Patients should be advised that serious skin reactions have been reported in association with Trileptal. In the event a skin reaction should occur while taking Trileptal, patients should consult with their physician immediately [see Warnings and Precautions (5.4)].

Patients should be instructed that a fever associated with other organ system involvement (rash, lymphadenopathy, etc.) may be drug related and should be reported to the physician immediately [see Warnings and Precautions (5.8)].

Patients should be advised that there have been rare reports of blood disorders reported in patients treated with Trileptal. Patients should be instructed to immediately consult with their physician if they experience symptoms suggestive of blood disorders [see Warnings and Precautions (5.9)]. 

Female patients of childbearing age should be warned that the concurrent use of Trileptal with hormonal contraceptives may render this method of contraception less effective [see Drug Interactions (7.2)]. Additional non-hormonal forms of contraception are recommended when using Trileptal.

Patients, their caregivers, and families should be counseled that AEDs, including Trileptal, may increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern should be reported immediately to healthcare providers.

Caution should be exercised if alcohol is taken in combination with Trileptal therapy, due to a possible additive sedative effect.

Patients should be advised that Trileptal may cause dizziness and somnolence. Accordingly, patients should be advised not to drive or operate machinery until they have gained sufficient experience on Trileptal to gauge whether it adversely affects their ability to drive or operate machinery.

Patients should be encouraged to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry if they become pregnant. This registry is collecting information about the safety of antiepileptic drugs during pregnancy. To enroll, patients can call the toll free number 1-888-233-2334 [see Use in Specific Populations (8.1)].