OLANZAPINE DISINT. TAB (ZYPREXA ZYDIS) BOXED WARNINGS: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS and SUICIDALITY AND ANTIDEPRESSANT DRUGS See full prescribing information for complete boxed warning. • Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. This medication is not approved for the treatment of patients with dementia-related psychosis. • Children, adolescents, and young adults taking antidepressants for major depressive disorder (MDD) and other psychiatric disorders are at increased risk of suicidal thinking and behavior. ******************************************************************************************************************************** * This medication is not for use in psychotic conditions related to dementia. * This medication may cause heart failure, sudden death, or pneumonia in older adults with dementia-related conditions. * You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment. * Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself. * Olanzapine is not for use in psychotic conditions related to dementia. * Olanzapine may cause heart failure, sudden death, or pneumonia in older adults with dementia-related conditions. 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 LOW BLOOD PRESSURE; KIDNEY DISEASE; LIVER PROBLEMS; EPILEPSY; DIABETES. * 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. * Peel blister pack with dry hands. Place orally disintegrating tablet on tongue and allow tablet to dissolve. * For orally disintegrating tablets, DO NOT remove the blister from the outer pouch until just before taking dose. WARNINGS/PRECAUTIONS: TOP * This medicine may cause dizziness, lightheadedness or fainting. Avoid sudden changes in posture. BE CAREFUL and slowly sit up or stand up. * This medicine may impair judgement, thinking or motor skills; DO NOT drive or operate machinery until reasonably certain that you can do so safely. * AVOID concurrent use of alcohol or other CNS depressants as it may intensify the drowsiness, dizziness, or lightheadedness effect of this medicine. * The risk of suicide attempt is inherent in psychotic illnesses and in patients with substance abuse. Close supervision is necessary. * Inform your doctor if you have KIDNEY DISEASE; monitoring of renal function and/or dose adjustment may be necessary. * Because of INTERACTIONS, report the use of any other prescription or nonprescription medicines, including natural/herbal remedies, to your doctor. * Inform your doctor if you have a history of SEIZURES or conditions that lower the seizure threshold e.g. Alzheimer dementia. * Notify doctor if you are pregnant, if pregnancy is suspected, or if you intend to become pregnant. * The results of some MEDICAL or LAB tests may be affected by this medicine. Inform the doctor in charge that you are taking this medicine. * Orally disintegrating tablets contain phenylalanine. * Notify your doctor if signs of HYPERGLYCEMIA develops [eg, excessive thirst or urination, positive test for glucose or ketones in urine]. * This medicine may affect BLOOD SUGAR levels in diabetics, dose adjustment of antidiabetic agents may be necessary. * It is not known if this drug is excreted in breast milk. Notify your doctor if you are breastfeeding. Stop taking this medicine and notify your doctor AS SOON AS POSSIBLE if you experience: Blurred vision; Unusual movements of eye, face, limb; Yellowing of eyes or skin; Muscle cramps; Skin rash; Shakiness; Rigidity; Movement problems; High blood sugar level; Weight gain. Other Common Side Effects: TOP Sleepiness; Jitteriness; Dizziness; Suicidal tendency; Rapid heart rate; Stomach discomfort or pain; Anxiety; Constipation; Dry mouth; Fever; Dizziness when getting up; Nasal congestion; Headache; Difficulty falling asleep; Nervousness. 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