RANOLAZINE ORAL ER (RANEXA) BEFORE USING THIS MEDICINE: Tell your doctor if you are having any of the following conditions: TOP KIDNEY DISEASE; LIVER PROBLEMS; HISTORY OF QTc PROLONGATION. * 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. * Swallow whole, DO NOT chew or break tablets. * 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. * AVOID GRAPEFRUIT while taking this medicine. * Because of INTERACTIONS, report the use of any other prescription or nonprescription medicines, including natural/herbal remedies, to your doctor. * This medicine may cause dizziness, lightheadedness or fainting. Avoid sudden changes in posture. BE CAREFUL and slowly sit up or stand up. * CAUTION: Do not drive or operate machinery until you are reasonably certain that this medicine will not adversely affect your ability to do so safely. * Watch for signs in changing heart rate or alterations in heart rate. Notify physician immediately. * SPECIAL POPULATIONS: * Pediatric: The safety or efficacy of this medicine in pediatric patients below 18 years of age has not been established. * This medicine SHOULD NOT BE USED during pregnancy UNLESS the potential benefit justifies the potential risk to the fetus. * Patients with Renal Impairment: Not recommended for use in patients with severe renal impairment (Creatinine Clearance <30 ml/minute). * GERIATRIC: Dose selection should be cautious reflecting decreased renal, hepatic and cardiac function; concomitant disease and drugs. * Patients with Hepatic Impairment: Administer with CAUTION to patients with liver disease. Other Common Side Effects: TOP Constipation; Dizziness; Nausea; Headache; Irregular heartbeat; Ringing in ears; Vertigo; Stomach discomfort or pain; Loss of consciousness (fainting); Dry mouth; Vomiting; Swelling of the extremities; Difficulty breathing; Slowness of heartbeat; Bloody or dark urine; Partial loss of sensation; Low blood pressure; Burning pain, tingling, or numbness; Shakiness; Blurred vision. 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