Country: Ísrael
Tungumál: enska
Heimild: Ministry of Health
QUETIAPINE AS FUMARATE
TZAMAL BIO-PHARMA LTD
N05AH04
TABLETS PROLONGED RELEASE
QUETIAPINE AS FUMARATE 400 MG
PER OS
Required
ASTRA ZENECA UK LIMITED
QUETIAPINE
QUETIAPINE
Seroquel XR is indicated for the treatment of Schizophrenia .Seroquel XR is effective in preventing relapse in stable schizophrenic patients who have been maintained on Seroquel XR. Seroquel XR is indicated for the treatment of moderate to severe manic episodes associated with bipolar disorder.Treatment of acute mania associated with bipolar I disorder as monotherapy or in combination with lithium or sodium valproate.Seroquel XR is indicated for the treatment of major depressive episodes in bipolar disorder. Seroquel XR is indicated for preventing recurrence in bipolar disorder in patients whose manic, mixed or depressive episode has responded to quetiapine treatment as monotherapy or in combination with lithium or sodium valproate. Seroquel XR is indicated for add-on treatment of major depressive episods in patients with Major Depressive Disorder (MDD) who have had sub-optimal response to antidepressant monotherapy (see section 5.1 Pharmacodynamic properties). Prior to initiating treatment, clinicians should consider the safety profile of Seroquel XR (see section 4.4 Special warnings and precautions for use).
2014-10-31
Patient Package Leaflet in Accordance With the Pharmacists’ Regulations (Preparations) – 1986 The medicine is dispensed with a doctor’s prescription only SEROQUEL XR ® SEROQUEL XR ® SEROQUEL XR ® 50 mg 150 mg 200 mg Prolonged -release Prolonged -release Prolonged -release tablets tablets tablets Composition: Each tablet contains: Each tablet contains: Each tablet contains: Quetiapine Quetiapine Quetiapine (as fumarate) (as fumarate) (as fumarate) 50 mg 150 mg 200 mg SEROQUEL XR ® SEROQUEL XR ® 300 mg 400 mg Prolonged -release Prolonged -release tablets tablets Composition: Each tablet contains: Each tablet contains: Quetiapine Quetiapine (as fumarate) (as fumarate) 300 mg 400 mg For inactive and allergenic ingredients please refer to 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. The medicine is not intended for children and adolescents below the age of 18 years. This medicine is not intended for elderly people who suffer from dementia. • Antidepressants and antianxiety medicines increase the risk of suicidal behavior and thoughts among children, adolescents and young adults up to 25 years of age. When starting treatment with this medicine, patients of all ages and their relatives, must monitor behavioral changes such as: worsening of depression, suicidal thoughts, aggressiveness etc. If changes such as these occur, refer immediately to the doctor. • Elderly patients who suffer from dementia-related psychosis, and are been treated with antipsychotics, have an increased risk of death. 1. WHAT IS THE MEDICINE INTENDED FOR? • to treat schizophrenia. • to treat Lestu allt skjalið
1. NAME OF THE MEDICINAL PRODUCT Seroquel XR 50 mg prolonged-release tablets Seroquel XR 150 mg prolonged-release tablets Seroquel XR 200 mg prolonged-release tablets Seroquel XR 300 mg prolonged-release tablets Seroquel XR 400 mg prolonged-release tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Seroquel XR 50 mg contains 50 mg quetiapine (as quetiapine fumarate) Seroquel XR 150 mg contains 150 mg quetiapine (as quetiapine fumarate) Seroquel XR 200 mg contains 200 mg quetiapine (as quetiapine fumarate) Seroquel XR 300 mg contains 300 mg quetiapine (as quetiapine fumarate) Seroquel XR 400 mg contains 400 mg quetiapine (as quetiapine fumarate) Excipients with known effect: Seroquel XR 50 mg contains 125.72 mg lactose monohydrate per tablet Seroquel XR 150 mg contains 74.65 mg lactose monohydrate per tablet Seroquel XR 200 mg contains 52.87 mg lactose monohydrate per tablet Seroquel XR 300 mg contains 49.31 mg lactose monohydrate per tablet Seroquel XR 400 mg contains15.50 mg lactose monohydrate per tablet For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Prolonged-release tablet Seroquel XR 50 mg tablets are peach-coloured and engraved with “XR 50” on one side Seroquel XR 150 mg: White, bi-convex, capsule shaped tablets, marked with XR150. 3 Seroquel XR 200 mg tablets are yellow and engraved with “XR 200” on one side Seroquel XR 300 mg tablets are pale yellow and engraved with “XR 300” on one side Seroquel XR 400 mg tablets are white and engraved with “XR 400” on one 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 XR 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 Lestu allt skjalið