Երկիր: Իսրայել
Լեզու: անգլերեն
Աղբյուրը: Ministry of Health
BREXPIPRAZOLE
LUNDBECK ISRAEL LTD.
N05AX16
FILM COATED TABLETS
BREXPIPRAZOLE 1 MG
PER OS
Required
H. LUNDBECK A/S, DENMARK
BREXPIPRAZOLE
REXULTI is indicated for:- As adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults- For treatment of schizophrenia in adults and pediatric patients ages 13 years and older.
2020-01-16
PATIENT LEAFLET IN ACCORDANCE WITH PHARMACIST’S REGULATIONS (PREPARATIONS) 1986 The medicine is marketed according to doctor’s prescription only. REXULTI 0.5 MG, REXULTI 1 MG, REXULTI 2 MG, REXULTI 3 MG, REXULTI 4 MG FILM COATED TABLETS COMPOSITION Each film coated tablet of Rexulti contains the active ingredient: Rexulti 0.5 mg: Brexpiprazole 0.5 mg Rexulti 1 mg: Brexpiprazole 1 mg Rexulti 2 mg: Brexpiprazole 2 mg Rexulti 3 mg: Brexpiprazole 3 mg Rexulti 4 mg: Brexpiprazole 4 mg INACTIVE INGREDIENTS See section 6. - READ THE LEAFLET CAREFULLY UNTIL THE END BEFORE USING THE MEDICATION. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or the pharmacist. - This medicine was prescribed for you. Do not pass it on to others. It may harm them even if their ailment/ medical condition seems similar to yours. 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. REXULTI IS NOT INTENDED FOR THE TREATMENT IN CASES OF DEMENTIA-RELATED PSYCHOSIS. SUICIDAL THOUGHTS AND BEHAVIORS ANTIDEPRESSANTS INCREASED THE RISK OF SUICIDAL THOUGHTS AND BEHAVIORS IN YOUNG PATIENTS AGED UP TO 24 YEARS IN SHORT-TERM STUDIES. MONITOR CLOSELY FOR CLINICAL WORSENING AND FOR EMERGENCE OF SUICIDAL THOUGHTS AND BEHAVIORS. REXULTI IS NOT INTENDED FOR CHILDREN. 1. WHAT IS THE MEDICINE FOR? REXULTI is intended for the treatment of adults with: • Major depressive disorder (MDD) in combination with antidepressant medicines. • Schizophrenia. THERAPEUTIC GROUP: atypical antipsychotic drugs 2. BEFORE USING THE MEDICINE SPECIAL WARNINGS REGARDING THE USE OF THE MEDICINE REXULTI MAY CAUSE SERIOUS SIDE EFFECTS, INCLUDING: • INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS. REXULTI IS NOT INTENDED FOR THE TREATMENT IN CASES OF DEMENTIA-RELATED PSYCHOSIS. (see framed warning at the beginning of the leaflet) • RISK OF SUICIDAL THOUGHT Կարդացեք ամբողջական փաստաթուղթը
REXULTI® 0.5 MG (BREXPIPRAZOLE 0.5 MG FILM COATED TABLETS) REXULTI® 1 MG (BREXPIPRAZOLE 1 MG FILM COATED TABLETS) REXULTI® 2 MG (BREXPIPRAZOLE 2 MG FILM COATED TABLETS) REXULTI® 3 MG (BREXPIPRAZOLE 3 MG FILM COATED TABLETS) REXULTI® 4 MG (BREXPIPRAZOLE 4 MG FILM COATED TABLETS) WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; AND SUICIDAL THOUGHTS AND BEHAVIORS 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. REXULTI IS NOT APPROVED FOR THE TREATMENT OF PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS _[SEE WARNINGS _ _AND PRECAUTIONS (5.1)]_. SUICIDAL THOUGHTS AND BEHAVIORS ANTIDEPRESSANTS INCREASED THE RISK OF SUICIDAL THOUGHTS AND BEHAVIORS IN PATIENTS AGED 24 YEARS AND YOUNGER IN SHORT-TERM STUDIES. MONITOR CLOSELY FOR CLINICAL WORSENING AND FOR EMERGENCE OF SUICIDAL THOUGHTS AND BEHAVIORS. THE SAFETY AND EFFICACY OF REXULTI HAVE NOT BEEN ESTABLISHED IN PEDIATRIC PATIENTS WITH MDD _[SEE WARNINGS _ _AND PRECAUTIONS (5.2)_, _USE IN SPECIFIC POPULATIONS (8.4)]_. 1 INDICATIONS AND USAGE REXULTI is indicated for: • As adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults. • For treatment of schizophrenia in adults and pediatric patients ages 13 years and older. 2 DOSAGE AND ADMINISTRATION 2.1 ADJUNCTIVE TREATMENT OF MAJOR DEPRESSIVE DISORDER (ADULTS) The recommended starting dosage for REXULTI as adjunctive treatment of MDD in adults is 0.5 mg or 1 mg once daily, taken orally with or without food_ [see Clinical Pharmacology (12.3)]._ Titrate to 1 mg once daily, then up to the target dosage of 2 mg once daily. Dosage increases should occur at weekly intervals based on the patient’s clinical response and tolerability. The maximum recommended daily dosage is 3 mg. Periodically reassess to determine the continued need and appropriate dosage for treatment. 2.2 TREATMENT OF SCHIZOPHRENIA (ADULTS AND P Կարդացեք ամբողջական փաստաթուղթը