Country: Iżrael
Lingwa: Ingliż
Sors: Ministry of Health
OLANZAPINE
ELI LILLY ISRAEL LTD, ISRAEL
N05AH03
TABLETS
OLANZAPINE 5 MG
PER OS
Required
LILLY S.A., SPAIN
OLANZAPINE
OLANZAPINE
Acute and maintenance treatment of schizophrenia. Zyprexa is indicated for the management of the manifestations of psychotic disorders. Zyprexa is indicated for the short-term treatment of acute manic episodes associated with Bipolar I Disorder. Prevention of recurrence in Bipolar Disorder : In patients whose manic episode has responded to olanzapine treatment Zyprexa is indicated for the prevention of recurrence in patients with Bipolar Disorder. Combination therapy in Bipolar I Disorder: The combination of Zyprexa with lithium or valproate is indicated for the short-term treatment of acute manic episodes associated with Bipolar I Disorder.
2022-03-31
I ZYPRTB A 12 Page 1 of 8 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 This medicine is to be supplied by a doctor’s prescription only ZYPREXA 5 MG Tablets COMPOSITION: Each tablet contains: olanzapine 5 mg ZYPREXA 7.5 MG Tablets COMPOSITION: Each tablet contains: olanzapine 7.5 mg ZYPREXA 10 MG Tablets COMPOSITION: Each tablet contains: olanzapine 10 mg INACTIVE INGREDIENTS AND ALLERGENS: See section 6 “Additional information” and “Important information regarding some of the ingredients of this medicine” in section 2. READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have any further questions, refer to the doctor or pharmacist. This medicine has been prescribed to treat your illness. Do not pass it on to others. It may harm them even if it seems to you that their illness is similar. VITAL INFORMATION ABOUT THIS MEDICINE: Antipsychotics (like ZYPREXA) can increase the risk of death in elderly people who are experiencing confusion, memory loss, and loss of touch with reality (dementia-related psychosis). This medicine is not intended for adult patients who suffer from dementia-related psychosis. ZYPREXA is intended for adults over 18 years of age. 1. WHAT IS THIS MEDICINE INTENDED FOR? Acute and maintenance treatment of schizophrenia. ZYPREXA is indicated for the management of the manifestations of psychotic disorders. ZYPREXA is indicated for the short-term treatment of acute manic episodes associated with Bipolar I Disorder. Prevention of recurrence in Bipolar Disorder: In patients whose manic episode has responded to olanazapine treatment, ZYPREXA is indicated for the prevention of recurrence in patients with Bipolar Disorder. Combination therapy in Bipolar I Disorder: The combination of ZYPREXA with lithium or valproate is indicated for the short-term treatment of acute manic episodes associated with Bipolar I Disorder. THERAPEUTIC GROUP: Atypical antipsychotic medic Aqra d-dokument sħiħ
X ZYPRTBVT A 13 Draft2 Page 1 of 24 ZYPREXA ZYPREXA® VELOTAB® 1 DOSAGE FORMS AND STRENGTHS ZYPREXA 5 mg, 7.5 mg, and 10 mg tablets ZYPREXA Velotab 5 mg and 10 mg orodispersible tablets (orally disintegrating tablets) WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS TREATED WITH ANTIPSYCHOTIC DRUGS ARE AT AN INCREASED RISK OF DEATH. ANALYSES OF SEVENTEEN PLACEBO-CONTROLLED TRIALS (MODAL DURATION OF 10 WEEKS), LARGELY IN PATIENTS TAKING ATYPICAL ANTIPSYCHOTIC DRUGS, REVEALED A RISK OF DEATH IN DRUG-TREATED PATIENTS OF BETWEEN 1.6 TO 1.7 TIMES THE RISK OF DEATH IN PLACEBO-TREATED PATIENTS. OVER THE COURSE OF A TYPICAL 10-WEEK CONTROLLED TRIAL, THE RATE OF DEATH IN DRUG-TREATED PATIENTS WAS ABOUT 4.5%, COMPARED TO A RATE OF ABOUT 2.6% IN THE PLACEBO GROUP. ALTHOUGH THE CAUSES OF DEATH WERE VARIED, MOST OF THE DEATHS APPEARED TO BE EITHER CARDIOVASCULAR (E.G., HEART FAILURE, SUDDEN DEATH) OR INFECTIOUS (E.G., PNEUMONIA) IN NATURE. OBSERVATIONAL STUDIES SUGGEST THAT, SIMILAR TO ATYPICAL ANTIPSYCHOTIC DRUGS, TREATMENT WITH CONVENTIONAL ANTIPSYCHOTIC DRUGS MAY INCREASE MORTALITY. THE EXTENT TO WHICH THE FINDINGS OF INCREASED MORTALITY IN OBSERVATIONAL STUDIES MAY BE ATTRIBUTED TO THE ANTIPSYCHOTIC DRUG AS OPPOSED TO SOME CHARACTERISTIC(S) OF THE PATIENTS IS NOT CLEAR. ZYPREXA (OLANZAPINE) IS NOT APPROVED FOR THE TREATMENT OF PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS [SEE WARNINGS AND PRECAUTIONS (5.1, USE IN SPECIFIC POPULATIONS (8.5)]. 2 INDICATIONS AND USAGE Zyprexa tablets and velotabs: Acute and maintenance treatment of schizophrenia. Zyprexa is indicated for the management of the manifestations of psychotic disorders. Zyprexa is indicated for the short-term treatment of acute manic episodes associated with Bipolar I Disorder. Prevention of recurrence in Bipolar Disorder: In patients whose manic episode has responded to olanzapine treatment Zyprexa is indicated for the prevention of recurrence in patients with Bipolar Disorder. Combinat Aqra d-dokument sħiħ