SEROQUEL 25 MG

国: イスラエル

言語: 英語

ソース: Ministry of Health

有効成分:

QUETIAPINE AS FUMARATE

から入手可能:

TZAMAL PHARMA

ATCコード:

N05AH04

医薬品形態:

FILM COATED TABLETS

構図:

QUETIAPINE AS FUMARATE 25 MG

投与経路:

PER OS

処方タイプ:

Required

製:

CHEPLAPHARM ARZNEIMITTEL GMBH, GERMANY

治療群:

QUETIAPINE

治療領域:

QUETIAPINE

適応症:

Indicated for the treatment of schizophrenia. Treatment of manic episodes associated with bipolar disorder.Treatment of major depressive episodes in bipolar disorders.

承認日:

2023-02-28

情報リーフレット

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

製品の特徴

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