NALTREXONE HCL ORAL (REVIA) BOXED WARNING: Hepatotoxicity: Naltrexone has the capacity to cause hepatocellular injury when given in excessive doses. Naltrexone is contraindicated in acute hepatitis or liver failure. Carefully consider its use in patients with active liver disease in light of its hepatotoxic effects. The margin of separation between the apparently safe dose of naltrexone and the dose causing hepatic injury appears to be only 5-fold or less. Naltrexone does not appear to be hepatotoxic at the recommended doses. Warn patients of the risk for hepatic injury and advise them to stop the use of naltrexone and seek medical attention if they experience symptoms of acute hepatitis. BEFORE USING THIS MEDICINE: Tell your doctor: TOP If you are PREGNANT. Tell your doctor if you are having any of the following conditions: TOP LIVER PROBLEMS. * 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 * This medicine can be taken with or without food, REGARDLESS of meal times. If stomach upset occurs, take with food. * This medicine should be taken or should be used ONCE DAILY. * DO NOT EXCEED recommended dosage. 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 medication may precipitate mild to severe withdrawal symptoms. * Inform your doctor if you have LIVER DISEASE; monitoring liver enzyme tests and/or dose adjustment and/or discontinue of drug may be necessary. * Notify doctor of any signs suggesting LIVER problems (eg, unusual fatigue, loss of appetite, nausea, vomiting, yellowing of eyes, dark urine). * The risk of suicide attempt is inherent in psychotic illnesses and in patients with substance abuse. Close supervision is necessary. * Patients should wear identification tags (Medic-Alert) to alert medical personnel, in case of an emergency, to your condition or drugs you're taking. * SPECIAL POPULATIONS: * Pediatric: The safety or efficacy of this medicine in pediatric patients below 18 years of age has not been established. Stop taking this medicine and notify your doctor AS SOON AS POSSIBLE if you experience: Sweating; Vomiting; Stomach discomfort or pain; Joint pain; Shakiness. Other Common Side Effects: TOP Headache; Blurred vision; Nervousness; Dizziness; Decreased appetite; Anxiety; Abnormal blood cell count; Difficulty falling asleep; Skin rash; Nausea. 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