PHENTERMINE+TOPIRAMATE ER ORAL (QSYMIA) ------------------------CONTRAINDICATIONS-------------------------- • Pregnancy • Glaucoma • Hyperthyroidism • During or within 14 days of taking monoamine oxidase inhibitors • Known hypersensitivity or idiosyncrasy to sympathomimetic amines ----------------WARNINGS AND PRECAUTIONS--------------------- • Fetal Toxicity: Females of reproductive potential: Obtain negative pregnancy test before treatment and monthly thereafter; use effective contraception. Qsymia is available through a limited program under a Risk Evaluation and Mitigation Strategy (REMS) • Increase in Heart Rate: Monitor heart rate in all patients, especially those with cardiac or cerebrovascular disease • Suicidal Behavior and Ideation: Monitor for depression or suicidal thoughts. Discontinue Qsymia if symptoms develop • Acute Myopia and Secondary Angle Closure Glaucoma: Discontinue Qsymia • Mood and Sleep Disorders: Consider dose reduction or withdrawal for clinically significant or persistent symptoms • Cognitive Impairment: May cause disturbances in attention or memory. Caution patients about operating automobiles or hazardous machinery when starting treatment • Metabolic Acidosis: Measure electrolytes before/during treatment •Elevated Creatinine: Measure creatinine before/during treatment • Use of Antidiabetic Medications: Weight loss may cause hypoglycemia. Measure serum BEFORE USING THIS MEDICINE: Tell your doctor if you are having any of the following conditions: TOP HEART CONDITION or HIGH BLOOD PRESSURE; THYROID problem; GLAUCOMA. * Inform your Doctor or Pharmacist if you are allergic to any prescription or non-prescription medicine; taking other medicines or have other medical problems; pregnant, planning a pregnancy, or breastfeeding. * Check with your Doctor, Pharmacists, or Nurse if information in this leaflet causes you special concern or if you want additional information about your medicine and its use. HOW MEDICINE IS ADMINISTERED? TOP Use this medicine exactly as directed on the label, unless instructed differently by your doctor * Take this medicine 30-60 minutes BEFORE MEAL(S). * DO NOT EXCEED recommended dosage. * Do not DISCONTINUE this medicine ABRUPTLY after prolonged usage. * To reduce risk of interactions with other medications, take at least 2 hours before or 1 hour after other medications. * Do not take this medicine after the evening meal or less than 4 hours before bedtime (not later than 6 pm). * A reduced-calorie DIET and increased physical activity are usually part of the treatment regimen. Follow prescribed diet and exercise programs. 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. * DO NOT exceed recommended dosage. Stop taking this medicine and notify your doctor AS SOON AS POSSIBLE if you experience: Dizziness; Burning pain, tingling, or numbness; Nervousness; Irregular heartbeat; Visual disturbances; Blurred vision; Eye pain; Chest pain; Decreased sweating; Urinary calculus (kidney stones). Other Common Side Effects: TOP Nausea; Sleepiness; Decreased appetite; Confusion; High blood pressure; Depression; Euphoria; Feeling uncoordinated; Shakiness; Difficulty falling asleep; Weight loss; Diarrhea; Restlessness; Stomach discomfort or pain; Jitteriness; Muscle weakness; Back pain; Speech difficulty; Constipation; Dry mouth; Indigestion; Flu-like symptoms; Skin rash; Menstrual irregularities; Swollen tongue; Increased thirst; ; Decreased sexual desire; Abnormal blood cell count; Increased sexual desire; Vomiting. 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