Seroquel XR 400mg prolonged-release tablets

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Quetiapine fumarate

Tilgjengelig fra:

Imbat Limited

ATC-kode:

N05AH; N05AH04

INN (International Name):

Quetiapine fumarate

Dosering :

400 milligram(s)

Legemiddelform:

Prolonged-release tablet

Resept typen:

Product subject to prescription which may not be renewed (A)

Terapeutisk område:

Diazepines, oxazepines, thiazepines and oxepines; quetiapine

Autorisasjon status:

Authorised

Autorisasjon dato:

2010-01-25

Informasjon til brukeren

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
SEROQUEL
® XR 400MG
PROLONGED-RELEASE TABLETS
(quetiapine)
Your medicine is available using the name Seroquel XR 400mg
prolonged-release tablets but will be referred to as Seroquel XR
throughout this leaflet.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START TAKING THIS MEDICINE.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or
pharmacist.

This medicine has been prescribed for you. Do not pass it on
to others. It may harm them, even if their symptoms are the
same as yours.

If you get any side effects talk to your doctor or pharmacist.
This includes any side effects not listed in this leaflet.
See Section 4.
IN THIS LEAFLET:
1.
What Seroquel XR is and what it is used for
2.
Before you take Seroquel XR
3.
How to take Seroquel XR
4.
Possible side effects
5.
How to store Seroquel XR
6.
Contents of the pack and other information
1.
WHAT SEROQUEL XR IS AND WHAT IT IS USED
FOR
Seroquel XR contains a substance called quetiapine. This belongs
to a group of medicines called anti-psychotics. Seroquel XR can be
used to treat several illnesses, such as:

Bipolar depression and major depressive episodes in major
depressive disorder: where you may feel sad or you may
find that you feel depressed, feel guilty, lack energy, lose
your appetite or can’t sleep.

Mania: where you may feel very excited, elated, agitated,
enthusiastic or hyperactive or have poor judgement
including being aggressive or disruptive.

Schizophrenia: where you may hear or feel things that are
not there, believe things that are not true or feel unusually
suspicious, anxious, confused, guilty, tense or depressed.
When Seroquel XR is being taken to treat major depressive
episodes in major depressive disorder, it will be taken in addition
to another drug being used to treat this illness.
Your doctor may continue to prescribe Seroquel XR even when
you are feeling better.
2.
BEFORE YOU TAKE SEROQUEL XR
DO NOT TAKE SEROQUEL XR

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Seroquel XR 400mg prolonged-release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 400mg quetiapine (as quetiapine fumarate)
Excipients: Also contains lactose.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Prolonged-release tablet
_Product imported from Italy and the UK:_
The tablet are white and engraved with “XR 400” on one side and
plain on the other.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Seroquel XR is indicated for:
treatment of Schizophrenia, including
•
preventing relapse in stable schizophrenic patients who have been
maintained on Seroquel XR.
treatment of bipolar disorder :
•
For the treatment of moderate to severe manic episodes in bipolar
disorder
•
For the treatment of major depressive episodes in bipolar disorder
•
For the prevention of recurrence in patients with bipolar disorder, in
patients whose manic or depressive episode
has responded to quetiapine treatment.
•
add-on treatment of major depressive episodes in patients with Major
Depressive Disorder (MDD) who have had
sub-optimal response to antidepressant monotherapy (see section 5.1).
Prior to initiating treatment, clinicians
should consider the safety profile of Seroquel XR (see section 4.4).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Different dosing schedules exist for each indication. It must
therefore be ensured that patients receive clear information
on the appropriate dosage for their condition.
Seroquel XR should be administered once daily, without food. The
tablets should be swallowed whole and not split,
chewed or crushed.
_ADULTS:_
FOR THE TREATMENT OF SCHIZOPHRENIA AND MODERATE TO SEVERE MANIC
EPISODES IN BIPOLAR DISORDER
Seroquel XR should be administrated at least one hour before a meal.
The daily dose at the start of therapy is 300 mg
on Day 1 and 600 mg on Day 2. The recommended daily dose is 600 mg,
however if clinically justified the dose may
be increased to 800 mg daily. The dose should