Seroquel 25 mg film-coated tablets

Pajjiż: Irlanda

Lingwa: Ingliż

Sors: HPRA (Health Products Regulatory Authority)

Ingredjent attiv:

Quetiapine

Disponibbli minn:

Imbat Limited

Kodiċi ATC:

N05AH04

INN (Isem Internazzjonali):

Quetiapine

Dożaġġ:

25 milligram(s)

Għamla farmaċewtika:

Film-coated tablet

Tip ta 'preskrizzjoni:

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

Żona terapewtika:

quetiapine

L-istatus ta 'awtorizzazzjoni:

Authorised

Data ta 'l-awtorizzazzjoni:

2008-02-01

Fuljett ta 'informazzjoni

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
SEROQUEL
® 25MG FILM-COATED 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 is and what it is used for
2.
What you need to know before you take Seroquel
3.
How to take Seroquel
4.
Possible side effects
5.
How to store Seroquel
6.
Contents of the pack and other information
1.
WHAT SEROQUEL IS AND WHAT IT IS USED FOR
Seroquel contains a substance called quetiapine. This belongs
to a group of medicines called anti-psychotics. Seroquel can
be used to treat several illnesses such as:

Bipolar depression: where you 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.
Your doctor may continue to prescribe Seroquel even when
you are feeling better.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
SEROQUEL
DO NOT TAKE SEROQUEL:

if you are allergic to quetiapine or any of the other
ingredients of this medicine (listed in section 6).

if you are taking any of the following medicines:

some medicines for HIV

azole medicines (for fungal infections)

erythromycin or clarithromycin (for infections)

nefazodone (for d

Karatteristiċi tal-prodott

Health Products Regulatory Authority
14 November 2019
CRN0094Q0
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Seroquel 25 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Seroquel 25 mg contains 25 mg quetiapine (as quetiapine fumarate)
Excipients: lactose monohydrate
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet
_Product imported from Italy and Austria_
Peach coloured, round tablets engraved with ‘SEROQUEL 25’ on one
side and plain on the other.
4 CLINICAL PARTICULARS
As per PA1019/019/001
5 PHARMACOLOGICAL PROPERTIES
As per PA1019/019/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
TABLET CORE :
Povidone
Calcium Hydrogen Phosphate Dihydrate
Microcrystalline Cellulose
Sodium Starch Glycollate Type A
Lactose Monohydrate
Magnesium Stearate
FILM-COATING :
Hypromellose
Macrogol 400
Titanium Dioxide (E171)
Ferric Oxide Yellow (E172)
Ferric Oxide Red (E172)
6.2 INCOMPATIBILITIES
Not Applicable
6.3 SHELF LIFE
The shelf life expiry date of this product shall be the date shown on
the container and outer package of the product on the
market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Health Products Regulatory Authority
14 November 2019
CRN0094Q0
Page 2 of 2
Do not store above 30°C. Store in the original package.
6.5 NATURE AND CONTENTS OF CONTAINER
Cardboard outer containing blister strips. Pack size : 30 or 60
tablets.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No special requirements
7 PARALLEL PRODUCT AUTHORISATION HOLDER
Imbat Limited
Unit L2
North Ring Business Park
Santry
Dublin 9
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1151/036/002
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 1st February 2008
10 DATE OF REVISION OF THE TEXT
November 2019