ZILEUTON ORAL (ZYFLO) BEFORE USING THIS MEDICINE: 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. * Patient should read specific "MEDICATION GUIDE" provided with this medicine before starting treatment and each time their prescription is renewed. * This medicine is NOT meant to relieve ACUTE asthmatic symptoms, which should be treated with inhaled, short-acting bronchodilator (e.g. albuterol). * Take regularly as prescribed, even during symptom-free periods. * Do not decrease the dose or stop taking any other prescribed medicines for this condition unless instructed by your physician. * Seek medical attention if short-acting bronchodilators are needed more often than usual or if more than the maximum number of inhalations is needed. 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. * Notify doctor of any signs suggesting LIVER problems (eg, unusual fatigue, loss of appetite, nausea, vomiting, yellowing of eyes, dark urine). * Because of INTERACTIONS, report the use of any other prescription or nonprescription medicines, including natural/herbal remedies, to your doctor. Stop taking this medicine and notify your doctor AS SOON AS POSSIBLE if you experience: Stomach discomfort or pain; Liver toxicity (yellow eyes or skin); Nausea. Other Common Side Effects: TOP Indigestion; Headache; Generalized pain; Muscle pain; Muscle weakness. 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