Country: Իսրայել
language: անգլերեն
source: Ministry of Health
OLANZAPINE
UNIPHARM LTD, ISRAEL
N05AH03
TABLETS ORODISPERSIBLE
OLANZAPINE 10 MG
PER OS
Required
TRIMA ISRAEL PHARMACEUTICAL PRODUCTS MAABAROT LTD, ISRAEL
OLANZAPINE
OLANZAPINE
Acute and maintenance treatment of schizophrenia. Zappa ODT is indicated for the management of the manifestations of psychotic disorders. Zappa ODT 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 Zappa ODT is indicated for the prevention of recurrence in patients with Bipolar Disorder. Combination therapy in Bipolar I Disorder: The combination of Zappa ODT with lithium or valproate is indicated for the short-term treatment of acute manic episodes associated with Bipolar I Disorder.
2018-06-30
0718E 119948010 PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed with a doctor’s prescription only. ZAPPA 5, 7.5, 10 ZAPPA ODT 5, 10 Tablets Orodispersible tablets COMPOSITION: Each ZAPPA 5 tablet contains: olanzapine 5 mg Each ZAPPA 7.5 tablet contains: olanzapine 7.5 mg Each ZAPPA 10 tablet contains: olanzapine 10 mg Each ZAPPA ODT 5 ORODISPERSIBLE tablet contains: olanzapine 5 mg Each ZAPPA ODT 10 ORODISPERSIBLE tablet contains: olanzapine 10 mg For the list of inactive ingredients, please see section 6. READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. This medicine has been prescribed for the treatment of your ailment. Do not pass it on to others. It may harm them, even if it seems to you that their ailment is similar. Essential information about the preparation: Antipsychotics (like ZAPPA and ZAPPA ODT) may increase the risk of death in elderly patients who suffer from confusion, memory loss and loss of touch with reality (dementia associated with psychosis). The preparation is not intended for treatment of psychosis in elderly patients who suffer from dementia. ZAPPA and ZAPPA ODT are intended for adults above the age of 18, due to the lack of information about its efficacy and safety in children and adolescents below the age of 18. 1. WHAT IS THE MEDICINE INTENDED FOR? ZAPPA and ZAPPA ODT are antipsychotics to treat schizophrenia patients and symptoms of psychotic disorders. In addition, the preparations are intended for the treatment of bipolar affective disorder. THERAPEUTIC GROUP: Atypical antipsychotic medicines. 2. BEFORE USING THE MEDICINE DO NOT USE THE PREPARATION IF: ∙ You are sensitive (allergic) to olanzapine or to any of the additional ingredients of the medicine. Signs of an allergic reaction include: rash, swallowing or breathing difficulties, swelling of the lips, face, read_full_document