Land: Ísrael
Tungumál: enska
Heimild: Ministry of Health
ARIPIPRAZOLE
UNIPHARM LTD, ISRAEL
N05AX12
TABLETS
ARIPIPRAZOLE 15 MG
PER OS
Required
UNIPHARM LTD, ISRAEL
ARIPIPRAZOLE
Ariply is indicated for the treatment of schizophrenia, for the treatment of moderate to severe manic episodes in Bipolar I disorder and for the prevention of a new manic episode in patient who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment.Ariply is indicated for use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD). Efficacy was established in two 6-week trials in adults with MDD who had an inadequate response to antidepressant therapy during the current episode.Ariply is indicated for the treatment of irritability associated with autistic disorder. Efficacy was established in two 8-week trials in pediatric patients (aged 6 to 17 years) with irritability associated with autistic disorder (including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods).
2018-09-03
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS )PREPARATIONS( – 1986 The medicine is dispensed with a doctor’s prescription only. ARIPLY 5, 10, 15, 30 TABLETS COMPOSITION: ARIPLY 5: Each tablet contains: Aripiprazole 5 mg ARIPLY 10: Each tablet contains: Aripiprazole 10 mg ARIPLY 15: Each tablet contains: Aripiprazole 15 mg ARIPLY 30: Each tablet contains: Aripiprazole 30 mg Inactive and allergenic ingredients in the preparation – see in section 2 “Important information about some of the ingredients of the medicine” and section 6 “Further information”. READ THE 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 medical condition is similar. Elderly patients with dementia-related psychosis treated with antipsychotics are at high risk of death. ARIPLY is not intended for the treatment of dementia- related psychosis. Antidepressants increase the risk of suicidal thoughts in children, adolescents and young adults up to the age of 25. When starting treatment with the medicine, patients of all ages and their relatives must monitor for behavioral changes, such as: worsening of depression, suicidal thoughts, aggressiveness and the like (see in section 2 “Special warnings regarding use of the medicine”). 1. WHAT IS THE MEDICINE INTENDED FOR? ARIPLY 5, 10, 15, 30 are intended: For treatment of schizophrenia. For treatment of moderate to severe manic states in bipolar disorder type 1 and for the prevention of new manic episodes in patients who experience predominantly manic episodes and who had previous manic episodes that responded to aripiprazole treatment. In addition, ARIPLY 5, 10, 15 are intended: For combined treatment of clinical depression (major depressive disorder [MDD]) for patients who Lestu allt skjalið
ARIPLY 5;10;15;30 1. NAME OF THE MEDICINAL PRODUCT: ARIPLY 5; ARIPLY 10; ARIPLY 15 and ARIPLY 30 1.1 QUALITATIVE AND QUANTITATIVE COMPOSITION • ARIPLY 5- Aripiprazole 5 mg, Tablet • ARIPLY 10 - Aripiprazole 10 mg, Tablet • ARIPLY 15- Aripiprazole 15 mg, Tablet • ARIPLY 30- Aripiprazole 30 mg, Tablet 2. THERAPEUTIC INDICATIONS : Ariply 5;10;15 and 30 Oral Tablets are indicated for the treatment of: • For the treatment of schizophrenia. • Acute Treatment of Manic and Mixed Episodes associated with Bipolar I [see Clinical Studies (15.2)] Ariply 5;10 and 15 Oral Tablets are indicated for the treatment of: • use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD). Efficacy was established in two 6- week trials in adults with MDD who had an inadequate response to antidepressant therapy during the current episode. • Irritability Associated with Autistic Disorder in Pediatric Patients (6 to 17 years) [see Clinical Studies (14.4)] WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS AND SUICIDAL THOUGHTS AND BEHAVIORS WITH ANTIDEPRESSANT DRUGS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Aripiprazole is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions (6.1)]. Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24 years; there was a reduction in risk with antidepressant use in patients aged 65 years and older [see Warnings and Precautions (6.3)]. In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber [see Lestu allt skjalið