SEROQUEL XR 300 MG

Land: Israel

Sprog: engelsk

Kilde: Ministry of Health

Aktiv bestanddel:

QUETIAPINE AS FUMARATE

Tilgængelig fra:

TZAMAL BIO-PHARMA LTD

ATC-kode:

N05AH04

Lægemiddelform:

TABLETS PROLONGED RELEASE

Sammensætning:

QUETIAPINE AS FUMARATE 300 MG

Indgivelsesvej:

PER OS

Recept type:

Required

Fremstillet af:

ASTRA ZENECA UK LIMITED

Terapeutisk gruppe:

QUETIAPINE

Terapeutisk område:

QUETIAPINE

Terapeutiske indikationer:

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).

Autorisation dato:

2014-10-31

Indlægsseddel

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

Produktets egenskaber

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