Seroquel XR 150mg prolonged-release tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Quetiapine

Available from:

AstraZeneca AB

ATC code:

N05AH; N05AH04

INN (International Name):

Quetiapine

Dosage:

150 milligram(s)

Pharmaceutical form:

Prolonged-release tablet

Prescription type:

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

Therapeutic area:

Diazepines, oxazepines, thiazepines and oxepines; quetiapine

Authorization status:

Marketed

Authorization date:

2009-01-30

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
SEROQUEL XR 50 MG, 150 MG, 200 MG, 300 MG, 400 MG PROLONGED-RELEASE
TABLETS
quetiapine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.

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 only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.

If you get any side effects talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Seroquel XR is and what it is used for
2.
What you need to know 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. 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.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE SEROQUEL XR
DO NOT TAKE SEROQUEL XR:

if you ar

Summary of Product characteristics

Health Products Regulatory Authority
14 July 2023
CRN00DQ1Q
Page 1 of 19
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Seroquel XR 150mg prolonged-release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Seroquel XR 150 mg contains 150 mg quetiapine (as quetiapine fumarate)
Excipients with known effect:
Seroquel XR 150 mg contains 71 mg lactose (anhydrous) per tablet
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release tablet
Seroquel XR 150 mg tablets are white and engraved with “XR 150” on
one side
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Seroquel XR is indicated for:

treatment of schizophrenia

treatment of bipolar disorder:
o For the treatment of moderate to severe manic episodes in bipolar
disorder
o For the treatment of major depressive episodes in bipolar disorder
o For the prevention of recurrence of manic or depressed episodes in
patients with bipolar disorder who previously 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 be adjusted within