TIAGABINE ORAL (GABITRIL) **SUICIDAL BEHAVIOR AND IDEATION Healthcare professionals should closely monitor all patients currently taking or starting any antiepileptic drug for notable changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior or depression. **USAGE IN PREGNANCY Patients should be encouraged to enroll in the 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. DISCOLORATION: FDA is warning the public that the anti-seizure medication Potiga (Ezogabine) can cause blue skin discoloration and eye abnormalities characterized by pigment changes in the retina. HOW MEDICINE IS ADMINISTERED? TOP Use this medicine exactly as directed on the label, unless instructed differently by your doctor * Take this medicine WITH food, a meal, or a snack. Do not take on an empty stomach. WARNINGS/PRECAUTIONS: TOP * Safety of use during pregnancy has not been established. This medicine SHOULD NOT BE USED DURING PREGNANCY unless benefit justifies potential risk to the fetus. CALL YOUR DOCTOR. * This medicine may cause drowsiness, dizziness, or blurred vision. DO NOT drive or operate machines until you know how you react to this medicine. * Notify doctor if you are pregnant, if pregnancy is suspected, or if you intend to become pregnant. * SPECIAL POPULATIONS: * Pediatric: The appropriate dosing and safety have not been established below the age of 13 years old. * Patients with Hepatic Impairment: A lower dose is recommended. * It is not known if this drug is excreted in human milk. Because of the potential for serious harm DO NOT breast feed. Other Common Side Effects: TOP Lightheadedness; Dizziness; Sleepiness; Muscle weakness; Nervousness; Nausea; Shakiness; Confusion; Stomach discomfort or pain; Speech difficulty; Irritability; Lack of concentration; Diarrhea; Vasodilatation; Walking abnormalities; Jitteriness; Feeling uncoordinated; Depression; Memory difficulty; Emotional lability; Hostility; Difficulty falling asleep; Language difficulty; Pendular or jerky eye movement; Burning pain, tingling, or numbness; Allerg. Reactions: rash, itch, urticaria; Increased appetite; Mouth ulcers; Vomiting; Cough; Inflammation of the pharynx; Generalized pain; Myasthenia gravis; . Other Common Side Effects: If symptoms are mild but do not go away or are bothersome, check with your doctor. IF ANY OF THE ABOVE SIDE EFFECTS IS SEVERE, CALL YOUR DOCTOR IMMEDIATELY. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. This leaflet has been developed by CliniDATA Source, Inc. based primarily on labeling information provided by the manufacturer. The information does not cover all possible uses, actions, precautions, side effects, or interactions of this medicine. It is not intended as medical advice for individual patients. Copyright © CliniDATA Source, Inc. 03/14. All rights reserved