国: イスラエル
言語: 英語
ソース: Ministry of Health
QUETIAPINE AS FUMARATE
TZAMAL PHARMA
N05AH04
FILM COATED TABLETS
QUETIAPINE AS FUMARATE 300 MG
PER OS
Required
CHEPLAPHARM ARZNEIMITTEL GMBH, GERMANY
QUETIAPINE
QUETIAPINE
Indicated for the treatment of schizophrenia. Treatment of manic episodes associated with bipolar disorder.Treatment of major depressive episodes in bipolar disorders.
2021-09-30
Patient Package Leaflet in Accordance With the Pharmacists’ Regulations (Preparations) – 1986 The medicine is dispensed with a doctor’s prescription only SEROQUEL® 25 mg SEROQUEL® 100 mg SEROQUEL® 200 mg SEROQUEL® 300 mg Film-coated tablets Film-coated tablets Film-coated tablets Film-coated tablets Composition - Each tablet contains: Quetiapine Quetiapine Quetiapine Quetiapine (as fumarate) (as fumarate) (as fumarate) (as fumarate) 25 mg 100 mg 200 mg 300 mg For inactive and allergenic ingredients, please see Section 2 "Important information about some of the ingredients of the medicine" and Section 6 – "Further Information". 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. This medicine is not intended for children and adolescents below the age of 18 years. This medicine is not intended for elderly people that suffer from dementia. • Antidepressants and anti-anxiety medicines increase the risk of suicidal behavior and thoughts in children, adolescents and young adults up to the age of 25. Upon initiation of treatment with the medicine, patients of all ages, and their relatives, must monitor behavioral changes such as: worsening of depression, suicidal thoughts, aggressiveness and the like. If such changes occur, refer to a doctor immediately. • Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. 1. WHAT IS SEROQUEL AND WHAT IS IT INTENDED FOR? - Treatment of schizophrenia. - Treatment of manic episodes associated with bipolar disorder. - Treatment of major depressive episodes in bipolar disorder. Seroquel is not indicated for the prevention of recurrence of manic or depressive episodes. Therapeutic group – antipsyc 完全なドキュメントを読む
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Seroquel 25 mg film-coated tablets Seroquel 100 mg film-coated tablets Seroquel 200 mg film-coated tablets Seroquel 300 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Seroquel 25 mg contains 25 mg quetiapine (as quetiapine fumarate) Seroquel 100 mg contains 100 mg quetiapine (as quetiapine fumarate) Seroquel 200 mg contains 200 mg quetiapine (as quetiapine fumarate) Seroquel 300 mg contains 300 mg quetiapine (as quetiapine fumarate) Excipients with known effect: Seroquel 25 mg contains 19 mg lactose monohydrate per tablet. Seroquel 100 mg contains 20.70 mg lactose monohydrate per tablet. Seroquel 200 mg contains 41.40 mg lactose monohydrate per tablet Seroquel 300 mg contains 62.10 mg lactose monohydrate per tablet. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet Seroquel 25 mg tablets are peach coloured, round biconvex and engraved with SEROQUEL 25 on one side Seroquel 100 mg tablets are yellow, round biconvex and engraved with SEROQUEL 100 on one side Seroquel 200 mg tablets are white, round biconvex and engraved with SEROQUEL 200 on one side Seroquel 300 mg tablets are white, capsule-shaped and engraved with SEROQUEL on one side and 300 on the other side 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. SEROQUEL IS NOT APPROVED FOR THE TREATMENT OF PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS SUICIDAL THOUGHTS AND BEHAVIOR 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; THERE WAS A REDUCTION IN RISK WITH ANTIDEPRESSANT U 完全なドキュメントを読む