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SEROQUEL XL 50 MG PROLONGED-RELEASE TABLETS

Active substance(s): QUETIAPINE / QUETIAPINE FUMARATE

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P039036

PACKAGE LEAFLET: INFORMATION FOR THE USER

Seroquel XL 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.
• 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 XL is and what it is used for
2. What you need to know before you take
Seroquel XL
3. How to take Seroquel XL
4. Possible side effects
5. How to store Seroquel XL
6. Contents of the pack and other information
1. What Seroquel XL is and what it is used for
Seroquel XL contains a substance called
quetiapine. This belongs to a group of medicines
called anti-psychotics. Seroquel XL can be used
to treat several illnesses, such as:
• Bipolar depression and major depressive
episodes in major depressive disorder: 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 judgment 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 XL 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 XL
even when you are feeling better.
2. What you need to know before you take
Seroquel XL
Do not take Seroquel XL:
• If you are allergic (hypersensitive) to quetiapine
or any of the other ingredients of Seroquel XL
(see section 6: Further information)
• 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 depression).
Do not take Seroquel XL if the above applies to
you. If you are not sure, talk to your doctor or
pharmacist before taking Seroquel XL.
Warnings and Precautions
Talk to your doctor or pharmacist before taking
Seroquel XL if:
• You, or someone in your family, have or have
had any heart problems, for example heart
rhythm problems, weakening of the heart
muscle or inflammation of the heart or if you
are taking any medicines that may have an
impact on the way your heart beats.
• You have low blood pressure.
• You have had a stroke, especially if you are
elderly.
• You have problems with your liver.
• You have ever had a fit (seizure).
• You have diabetes or have a risk of getting
diabetes. If you do, your doctor may check
your blood sugar levels while you are taking
Seroquel XL.
• You know that you have had low levels of white
blood cells in the past (which may or may not
have been caused by other medicines).
• You are an elderly person with dementia
(loss of brain function). If you are, Seroquel XL
should not be taken because the group of
medicines that Seroquel XL belongs to may
increase the risk of stroke, or in some cases
the risk of death, in elderly people with
dementia.
• You or someone else in your family has
a history of blood clots, as medicines like
these have been associated with formation of
blood clots.
Tell your doctor immediately if you experience any
of the following after taking Seroquel XL:
• A combination of fever, severe muscle
stiffness, sweating or a lowered level of
consciousness (a disorder called “neuroleptic
malignant syndrome”). Immediate medical
treatment may be needed.
• Uncontrollable movements, mainly of your face
or tongue.
• Dizziness or a severe sense of feeling sleepy.
This could increase the risk of accidental injury
(fall) in elderly patients.
• Fits (seizures).
• A long-lasting and painful erection (Priapism).
These conditions can be caused by this type of
medicine.
Tell your doctor as soon as possible if you have:
• A fever, flu-like symptoms, sore throat, or any
other infection, as this could be a result of a
very low white blood cell count, which may
require Seroquel XL to be stopped and/or
treatement to be given.
• Constipation along with persistent abdominal
pain, or constipation which has not responded
to treatment, as this may lead to a more
serious blockage of the bowel.
Thoughts of suicide and worsening of your
depression
If you are depressed you may sometimes have
thoughts of harming or killing yourself. These
may be increased when first starting treatment,
since these medicines all take time to work,
usually about two weeks but sometimes longer.
These thoughts may also be increased if you
suddenly stop taking your medication. You may
be more likely to think like this if you are a young
adult. Information from clinical trials has shown
an increased risk of suicidal thoughts and/or
suicidal behaviour in young adults aged less than
25 years with depression.
If you have thoughts of harming or killing yourself
at any time, contact your doctor or go to a hospital
straight away. You may find it helpful to tell a
relative or close friend that you are depressed,
and ask them to read this leaflet. You might ask
them to tell you if they think your depression
is getting worse, or if they are worried about
changes in your behaviour.
Weight gain
Weight gain has been seen in patients taking
Seroquel XL. You and your doctor should check
your weight regularly.
Children and Adolesecents
Seroquel XL is not for use in children and
adolescents below 18 years of age.

Other medicines and Seroquel XL
Tell your doctor if you are taking or have recently
taken any other medicines.
Do not take Seroquel XL 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 depression).
Tell your doctor if you are taking any of the
following medicines:
• Epilepsy medicines (like phenytoin or
carbamazepine).
• High blood pressure medicines.
• Barbiturates (for difficulty sleeping).
• Thioridazine or Lithium (other anti-psychotic
medicines).
• Medicines that have an impact on the way
your heart beats, for example, drugs that can
cause an imbalance in electrolytes (low levels
of potassium or magnesium) such as diuretics
(water pills) or certain antibiotics (drugs to treat
infections).
• Medicines that can cause constipation.
Before you stop taking any of your medicines,
please talk to your doctor first.
Seroquel XL with food, drink and alcohol
• Seroquel XL can be affected by food and you
should therefore take your tablets at least
one hour before a meal or prior to bedtime.
• Be careful how much alcohol you drink. This is
because the combined effect of Seroquel XL
and alcohol can make you sleepy.
• Do not drink grapefruit juice while you are
taking Seroquel XL. It can affect the way the
medicine works.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think
you may be pregnant or planning to have a
baby ask your doctor for advice before taking
Seroquel XL. You should not take Seroquel XL
during pregnancy unless this has been discussed
with your doctor. Seroquel should not be taken if
you are breast-feeding.
The following symptoms which can represent
withdrawal may occur in newborn babies of
mothers that have used Seroquel in the last
trimester (last three months of their pregnancy):
shaking, muscle stiffness and/or weakness,
sleepiness, agitation, breathing problems, and
difficulty in feeding. If your baby develops any
of these symptoms you may need to contact
your doctor.
Driving and using machines
Your tablets may make you feel sleepy. Do not
drive or use any tools or machines until you know
how the tablets affect you.
Seroquel XL contains lactose
Seroquel XL contains lactose which is a type of
sugar. If you have been told by your doctor that
you have an intolerance to some sugars, talk to
your doctor before taking this medicine.
Effect on Urine Drug Screens
If you are having a urine drug screen, taking
Seroquel may cause positive results for
methadone or certain drugs for depression called
tricyclic antidepressants (TCAs) when some test
methods are used, even though you may not be
taking methadone or TCAs. If this happens, a
more specific test can be performed.
3. How to take Seroquel XL
Always take Seroquel XL exactly as your doctor
has told you. You should check with your doctor
or pharmacist if you are not sure. Your doctor will
decide on your starting dose. The maintenance
dose (daily dose) will depend on your illness and
needs but usually between 150 mg and 800 mg.
• You will take your tablets once a day.
• Do not split, chew or crush the tablets.
• Swallow your tablets whole with a drink
of water.
• Take your tablets without food (at least
one hour before a meal or at bedtime, your
doctor will tell you when).
• Do not drink grapefruit juice while you are
taking Seroquel XL. It can affect the way the
medicine works.
• Do not stop taking your tablets even if you feel
better, unless your doctor tells you.
Liver problems
If you have liver problems your doctor may
change your dose.
Elderly people
If you are elderly your doctor may change your
dose dose.
Use in children and adolescents
Seroquel XL should not be used by children and
adolescents aged under 18 years.
If you take more Seroquel XL than you should
If you take more Seroquel XL than prescribed by
your doctor, you may feel sleepy, feel dizzy and
experience abnormal heart beats. Contact your
doctor or nearest hospital straight away. Take the
Seroquel XL tablets with you.
If you forget to take a dose of Seroquel XL
If you forget to take a dose, take it as soon as
you remember. If it is almost time to take the next
dose, wait until then. Do not take a double dose to
make up for a forgotten tablet.
If you stop taking Seroquel XL
If you suddenly stop taking Seroquel XL, you may
be unable to sleep (insomnia), or you may feel
sick (nausea), or you may experience headache,
diarrhoea, being sick (vomiting), dizziness or
irritability. Your doctor may suggest you reduce
the dose gradually before stopping treatment.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Seroquel XL can cause side
effects, although not everybody gets them.
Very common side effects (may affect more
than 1 in 10 people):
• Dizziness (may lead to falls), headache,
dry mouth.
• Feeling sleepy (this may go away with time, as
you keep taking Seroquel) (may lead to falls).
• Discontinuation symptoms (symptoms which
occur when you stop taking Seroquel) include
not being able to sleep (insomnia), feeling sick
(nausea), headache, diarrhoea, being sick
(vomiting), dizziness and irritability. Gradual
withdrawal over a period of at least 1 to 2 weeks
is advisable.
• Putting on weight.
• Abnormal muscle movements. These
include difficulty starting muscle movements,
shaking, feeling restless or muscle stiffness
without pain.
• Changes in the amount of certain fats
(trigylcerides and total cholesterol).

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Common side effects (may affect up to 1 in
10 people):
• Rapid heartbeat.
• Feeling like your heart is pounding, racing or
has skipped beats.
• Constipation, upset stomach (indigestion).
• Feeling weak.
• Swelling of arms or legs.
• Low blood pressure when standing up. This may
make you feel dizzy or faint (may lead to falls).
• Increased levels of sugar in the blood.
• Blurred vision.
• Abnormal dreams and nightmares.
• Feeling more hungry.
• Feeling irritated.
• Disturbance in speech and language.
• Thoughts of suicide and worsening of your
depression.
• Shortness of breath.
• Vomiting (mainly in the elderly).
• Fever.
• Changes in the amount of thyroid hormones in
your blood.
• Decreases in the number of certain types of
blood cells.
• Increases in the amount of liver enzymes
measured in the blood.
• Increases in the amount of the hormone prolactin
in the blood. Increases in the hormone prolactin
could in rare cases lead to the following:
- men and women to have swelling of breasts
and unexpectedly produce breast milk.
- women to have no monthly period or irregular
periods.
Uncommon side effects (may affect up to 1 in
100 people):
• Fits or seizures
• Allergic reactions that may include raised
lumps (weals), swelling of the skin and swelling
around the mouth.
• Unpleasant sensation in the legs (also called
restless legs syndrome).
• Difficulty swallowing
• Uncontrollable movements, mainly of your face
or tongue.
• Sexual dysfunction.
• Diabetes.
• Change in electrical activity of the heart seen
on ECG (QT prolongation).
• A slower than normal heart rate which may
occur when starting treatment and which may be
associated with low blood pressure and fainting.
• Difficulty in passing urine.
• Fainting (may lead to falls).
• Stuffy nose.
• Decrease in the amount of red blood cells.
• Decrease in the amount of sodium in the blood.
Rare side effects (may affect up to 1 in
1,000 people):
• A combination of high temperature (fever),
sweating, stiff muscles, feeling very drowsy or
faint (a disorder called “neuroleptic malignant
syndrome”).
• Yellowing of the skin and eyes (jaundice).
• Inflammation of the liver (hepatitis).
• A long-lasting and painful erection (priapism).
• Swelling of breasts and unexpected production
of breast milk (galactorrhoea).
• Menstrual disorder.
• Blood clots in the veins especially in the legs
(symptoms include swelling, pain and redness
in the leg), which may travel through blood
vessels to the lungs causing chest pain and
difficulty in breathing. If you notice any of these
symptoms seek medical advice immediately.
• Walking, talking, eating or other activities while
you are asleep.
• Body temperature decreased (hypothermia).
• Inflammation of the pancreas.
• A condition (called “metabolic syndrome”)
where you may have a combination of 3 or
more of the following: an increase in the fat
around your abdomen, a decrease in “good
cholesterol” (HDL-C), an increase in a type of
fat in your blood called trigylcerides, high blood
pressure and an increase in your blood sugar.
• Combination of fever, flu-like symptoms, sore
throat, or any other infection with very low
white blood cell count, a condition called
agranulocytosis.
• Bowel obstruction.
• Increased blood creatine phosphokinase
(a substance from muscles).
Very rare side effects (may affect up to 1 in
10,000 people):
• Severe rash, blisters, or red patches on the skin.
• A severe reaction (called anaphylaxis) which
may cause difficulty in breathing or shock.
• Rapid swelling of the skin, usually around the
eyes, lips and throat (angioedema).
• A serious blistering condition of the skin, mouth,
eyes and genitals (Stevens-Johnson syndrome)
• Inappropriate secretion of a hormone that
controls urine volume.
• Breakdown of muscle fibers and pain in
muscles (rhabdomyolysis).
• Worsening of pre-existing diabetes.
Not known (frequency cannot be estimated
from the available data)
• Skin rash with irregular red spots (erythema
multiforme).
• Serious, sudden allergic reaction with symptoms
such as fever and blisters on the skin and
peeling of the skin (toxic epidermal necrolysis).
• Symptoms of withdrawal may occur in newborn
babies of mothers that have used Seroquel XL
during their pregnancy.
The class of medicines to which Seroquel XL
belongs can cause heart rhythm problems, which
can be serious and in severe cases fatal.
Some side effects are only seen when a blood test
is taken. These include changes in the amount
of certain fats (triglycerides and total cholesterol)
or sugar in the blood, changes in the amount of
thyroid hormones in your blood, increased liver
enzymes, decreases in the number of certain types
of blood cells, decrease in the amount of red blood
cells, increased blood creatine phosphokinase
(a substance in the muscles), decrease in the
amount of sodium in the blood, and increases in
the amount of the hormone prolactin in the blood.
Increases in the hormone prolactin could in rare
cases lead to the following:
• Men and women to have swelling of breasts
and unexpectedly produce breast milk.
• Women to have no monthly period or irregular
periods.
Your doctor may ask you to have blood tests from
time to time.
Side effects in children and adolescents
The same side effects that may occur in adults
may also occur in children and adolescents.
The following side effects have been seen more
often in children and adolescents or have not
been seen in adults:
Very Common side effects (may affect more
than 1 in 10 people):
• Increase in the amount of a hormone called
prolactin, in the blood. Increases in the hormone
prolactin could in rare cases lead to the following:
- boys and girls to have swelling of breasts
and unexpectedly produce breast milk
- girls to have no monthly period or irregular
periods.
• Increased appetite.
• Vomiting.
• Abnormal muscle movements. These include
difficulty starting muscle movements, shaking,
feeling restless or muscle stiffness without pain.
• Increase in blood pressure.
Common side effects (may affect up to 1 in
10 people):
• Feeling weak, fainting (may lead to falls).
• Stuffy nose.
• Feeling irritated.
Reporting of side effects
If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet. You can also report
side effects directly via the Yellow Card Scheme
(Website: www.mhra.gov.uk/yellowcard). By
reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Seroquel XL
• Keep this medicine out of the reach and sight
of children.
• Do not use Seroquel XL after the expiry date
which is stated on the container after EXP. The
expiry date refers to the last day of that month.
• Seroquel XL does not require any special
storage conditions.
• Do not throw away medicines via wastewater or
household waste. Ask your pharmacist how to
throw away medicines you no longer use. These
measures will help to protect the environment.
6. Contents of the pack and other information
What Seroquel XL contains
• The active substance is quetiapine. Seroquel XL
tablets contain 50 mg, 150 mg, 200 mg, 300 mg
or 400 mg of quetiapine (as quetiapine fumarate).
• The other ingredients are:
Tablet core: microcrystalline cellulose, sodium
citrate, lactose monohydrate, magnesium
stearate, hypromellose.
Tablet coating: hypromellose , macrogol,
titanium dioxide (E171). The 50 mg, 200 mg
and 300 mg tablets also contain iron oxide
yellow (E172) and the 50 mg tablets contain
iron oxide red (E172).
What Seroquel XL looks like and contents of
the pack
All prolonged-release tablets are capsule shaped
and marked with XR and the strength. 50 mg
tablets are peach coloured; 150 mg tablets
are white coloured; 200 mg tablets are yellow
coloured; 300 mg tablets are pale yellow coloured
and 400 mg tablets are white coloured.
Pack sizes of 10, 30, 50, 60 and 100 tablets are
registered for all strengths. Not all pack sizes may
be available.
Marketing Authorisation Holder and Manufacturer
• The marketing authorisations for
Seroquel XL are held by AstraZeneca UK Ltd,
600 Capability Green, Luton, LU1 3LU,
United Kingdom.
• The tablets are made by AstraZeneca UK Ltd,
Silk Road Business Park, Macclesfield,
Cheshire, SK10 2NA, United Kingdom.
This medicinal product is authorised in
the Member States of the EEA under the
following names:
Country
Trade name
Austria
Seroquel XR
Belgium
Seroquel XR
Cyprus
Seroquel XR
Czech Republic Seroquel Prolong
Denmark
Seroquel Prolong
Estonia
Seroquel XR
Finland
Seroquel Prolong
France
Xeroquel LP
Germany
Seroquel Prolong® 50 mg
Retardtabletten,
Seroquel Prolong® 150 mg
Retardtabletten,
Seroquel Prolong® 200 mg
Retardtabletten,
Seroquel Prolong® 300 mg
Retardtabletten,
Seroquel Prolong® 400 mg
Retardtabletten
Greece
Seroquel XR
Hungary
Seroquel XR
Iceland
Seroquel Prolong
Ireland
Seroquel XR
Italy
Seroquel compresse a rilascio
prolungato
Latvia
Seroquel XR
Lithuania
Seroquel XR
Luxembourg
Seroquel XR
Malta
Seroquel XR
Netherlands
Seroquel XR
Norway
Seroquel Depot
Portugal
Seroquel SR
Romania
Seroquel XR
Slovakia
Seroquel XR
Slovenia
Seroquel SR
Spain
Seroquel Prolong
Sweden
Seroquel Depot
United Kingdom Seroquel XL

To listen to, or request
a copy of this leaflet in
Braille, large print or audio
please call, free of charge:
0800 198 5000 (UK only).
Please be ready to give the
following information:
Product
Reference
name
number
Seroquel XL PL 17901/0249
prolonged
release tablets
50 mg
Seroquel XL PL 17901/0259
prolonged
release tablets
150 mg
Seroquel XL PL 17901/0250
prolonged
release tablets
200 mg
Seroquel XL PL 17901/0251
prolonged
release tablets
300 mg
Seroquel XL PL 17901/0252
prolonged
release tablets
400 mg
This is a service provided
by the Royal National
Institute of Blind People.
This leaflet was last revised in August 2014.
CNS 14 0014
Seroquel XL is a trade mark of the AstraZeneca
group of companies.
© AstraZeneca 2014
You can also get information on mental health
from the following national organisations:
• MIND (National Association for Mental Health):
Mindinfoline: 0845 7660163
• RETHINK (Formerly the National
Schizophrenia Fellowship) Advice Service:
0208 9746814
• National Schizophrenia Fellowship (Scotland):
0131 662 4359
• SANELINE Helpline: 0845 7678000

P039036

442307-A01
02-10-14
P039036

Black

Technical Info

630170L4
1229

Profile

Seroquel XR 50mg, 150mg, 200mg,
300mg, 400mg Leaflet: Patient GB
KL

Body text size

Smallest text size

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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